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Modafinil

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Modafinil does in the body

Modafinil blocks the pump that clears dopamine out of the synapse, which leaves more dopamine sitting between neurons.

That is the same direction of effect as a stimulant, which is why it is a controlled substance, though it is much weaker and does not trigger dopamine release. It also raises orexin and histamine signalling, the systems that hold the brain in a waking state, which is why it produces wakefulness rather than agitation. It does not replace sleep; it postpones the experience of needing it.

Why people take it. Prescribed for excessive sleepiness; taken off-label to think better

What happened in people

Pooled cognitive effect in healthy non-sleep-deprived adults of SMD 0.12 (p = .01), with memory updating the only significant domain at SMD 0.28

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.

The limit that matters most

That an effect size of 0.12 in laboratory tasks corresponds to a meaningful advantage in real work, which the meta-analysts explicitly decline to conclude

Where it acts
Dopamine transporters in caudate, putamen and nucleus accumbens; orexin and histamine systems in the hypothalamus
Kind of result
Symptoms and quality of life
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.

What the registries record it as

  • Its recorded molecular formula is C15H15NO2S, weighing 273.35.

    US prescribing information · 5b8496fe-b647-4ce6-aeef-71245712e46f · read 2026-08-30

Where each sentence above came from

A person wrote this explanation into the record, with the studies named in the path below.

The recorded use, written for a reader without medical training. Not signed off.

A limit recorded against this substance. Not signed off as a reviewed claim.

The four opening statements run to 118 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Stand-in result

A stand-in result is a number measured because the real result takes too long.

A picture of it, and where the picture fails

It is like judging a journey by the speedometer rather than by arriving.

Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.

What people get wrong. A stand-in result is often reported as the result itself.

A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.

Randomisation

Randomisation means chance decides who gets which treatment.

A picture of it, and where the picture fails

It is like a coin toss deciding the groups.

Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.

What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.

Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.

Absolute difference

An absolute difference is how many more people in a hundred were affected.

A picture of it, and where the picture fails

It is like counting heads in two rooms of a hundred.

Where that stops being true. Heads are easy to count. Study results carry a margin of error too.

What people get wrong. It is confused with a percentage change, which can look far larger.

The arithmetic difference in event rates between arms.

Confidence interval

A confidence interval is the range the true answer is likely to sit in.

A picture of it, and where the picture fails

It is like a weather forecast giving a range rather than one number.

Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.

What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.

An interval estimate that would contain the true parameter in a stated proportion of repeated studies.

What happened in peopleRead from sources, not yet reviewed

What was measured, goal by goal

One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.

Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.

There is no single score. A strong test result and a weak life result are different facts.

Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
EnergyNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Waiting for a reviewer3 registered symptom measure.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
SleepNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
FocusNothing in the sources checkedNo registered study lists a life outcome for this goal.Waiting for a reviewer1 registered performance measure of this kind.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
PainNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Waiting for a reviewer1 registered symptom measure.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Energy
fatigue severity scale; fatigue; multidimensional fatigue inventory
Sleep
sleep latency; multiple sleep latency test; total sleep time
Focus
cognitive test scores at end of treatment period; cognitive performance
Pain
pain

Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.

What each mark on this table means
Nothing in the sources checked
No registered study lists a life outcome for this goal.
Waiting for a reviewer
3 registered symptom measure.
Not recorded
Harms were not a registered measure for this goal.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Change in dopamine D2/D3 receptor and dopamine transporter availability after modafinil versus placebo

The study showed what it set out to show

Who was studied
Volkow 2009 positron emission tomography study in healthy men
How many people
10
Study design
Phase 1 mechanistic imaging, placebo-controlled within subject
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Nucleus accumbens [11C]raclopride binding potential down 19.4% (95% CI 5-35, P = .02); caudate dopamine transporter occupancy 53.8% (95% CI 43.9-63.6, P < .001)
Repeated elsewhere
Partially Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. The authors flag abuse and dependence potential in vulnerable populations as the clinical implication, which was not the framing under which the drug was being prescribed at the time.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, 100 mg and 200 mg, once daily in the morning or one hour before a shift

Interval reported. 95% CI 5-35, P =

Written into the record, not signed off as a reviewed claim.

Cognitive performance against placebo by domain: executive function, spatial working memory, recall, selective attention, sustained attention

The study showed what it set out to show

Who was studied
Roberts 2020 meta-analysis of modafinil in healthy non-sleep-deprived adults
How many people
0
Study design
Meta-analysis of 14 randomised placebo-controlled studies, 64 effect sizes
Compared against
A dummy treatment
Kind of result
What a body can do day to day
What was found
Overall SMD 0.12 (p = .01); memory updating SMD 0.28 (p = .03); no other domain significant. Methylphenidate SMD 0.21 overall; D-amphetamine no effect
Repeated elsewhere
Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. The authors note that the experiments do not accurately reflect actual use in the wider population and that user perception of effectiveness is not supported by the evidence.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, 100 mg and 200 mg, once daily in the morning or one hour before a shift

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

Cognitive effects of modafinil by testing paradigm complexity

The study showed what it set out to show

Who was studied
Battleday 2015 systematic review, 1990 to 2014
How many people
0
Study design
Systematic review of primary studies in healthy non-sleep-deprived humans
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Most basic-paradigm studies showed enhanced executive function; only half showed improved attention or learning and memory; a few reported impaired divergent creative thinking. Complex assessments showed more consistent enhancement
Repeated elsewhere
Partially Replicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, 100 mg and 200 mg, once daily in the morning or one hour before a shift

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

Incidence of rash resulting in discontinuation

The study did not show it

Who was studied
Paediatric clinical trial programme, rash safety
How many people
1585
Study design
Pooled paediatric clinical trials supporting the label safety statement
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
13 of 1,585 (approximately 0.8%) discontinued for rash, including one possible Stevens-Johnson syndrome and one apparent multi-organ hypersensitivity reaction; 0 of 380 placebo recipients. Median time to rash 13 days
Repeated elsewhere
Replicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. Modafinil is not approved for paediatric use in any indication, and no factor is known that predicts occurrence or severity of the rash.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, 100 mg and 200 mg, once daily in the morning or one hour before a shift

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

What we know
RNAWiki holds 4 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What happened in peopleRead from sources, not yet reviewed

How close this is to real life

The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.

  1. Living longer, or avoiding a major event No evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
  2. What a body can do day to day Evidence recorded. Walking, dressing, breathing, recovering.1 registered measure of this kind.
  3. Measured performance Evidence recorded. How much was lifted, how far was run, how fast.1 registered measure of this kind.
  4. Symptoms and quality of life Evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.5 registered measures of this kind.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.7 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

Higher on these steps means closer to something a person would feel. It does not mean better done.

What it changes in the bodyRead from sources, not yet reviewed

The path through the body

From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.

Where a source records it acting

  • Brain: Binds to the dopamine transporter and inhibits dopamine reuptake in vitro; the label records that this has been associated in vivo with increased extracellular dopamine levels in some brain regions of animals, and states that the mechanism through which modafinil promotes wakefulness is unknown

    US prescribing information · 013450dd-cd42-46c7-98d6-9a2925761978 · read 2026-08-28

  1. Start

    Modafinil

    What a person takes: Oral tablet, 100 mg and 200 mg, once daily in the morning or one hour before a shift.

    The measurement behind this step

    A simple immediate-release tablet. The approved regimens are once daily in the morning for narcolepsy and sleep apnoea, and one hour before the start of a shift for shift work disorder. Off-label use spans a wide dose range and indefinite duration, neither of which has been studied.

  2. Getting in

    Absorbed orally, once daily

    A tablet taken in the morning, or an hour before a night shift. It lasts most of a working day.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Well absorbed orally with a half-life supporting once-daily dosing at 200 mg. Cleared mainly by amide hydrolysis to modafinil acid and by oxidation to modafinil sulfone, both inactive. Armodafinil, the R-enantiomer, has a longer effective half-life and is a separate approved product.

  3. Reaching the cell

    Crosses into the brain

    It is small and lipophilic enough to reach the brain from the bloodstream without help.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Passive diffusion across the blood-brain barrier; distribution to striatal, hypothalamic and cortical regions. The positron emission tomography work established that at clinically used doses it reaches concentrations sufficient to occupy roughly half of striatal dopamine transporters.

  4. What it acts on

    Blocks the dopamine pump without forcing dopamine out

    It jams the transporter that recycles dopamine, so dopamine lingers. It does not push dopamine out of the neuron the way amphetamine does.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Low-affinity, atypical inhibition of the dopamine transporter with 47-54% occupancy in caudate and putamen at 200-400 mg. Unlike amphetamine it does not reverse the transporter or trigger vesicular release, which is the pharmacological basis for its lower — but not absent — abuse liability. The label records that it is nonetheless reinforcing in cocaine-trained primates.

  5. The change it makes

    Wake-promoting networks are reinforced downstream

    Raised dopamine and noradrenaline feed into the orexin and histamine systems, which are what hold the brain awake.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Increased cortical catecholamines with indirect upregulation of serotonin, glutamate, orexin and histamine and indirect reduction of GABA. Orexinergic and histaminergic tone in the tuberomammillary and lateral hypothalamic systems is what distinguishes a eugeroic effect from generalised stimulation, and is why the drug promotes wakefulness without the peripheral sympathetic load of amphetamine.

  6. What that does for a person

    Reliable wakefulness, marginal cognition

    It works well for the thing it is approved for. For making a rested person smarter, the pooled effect across trials is small.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    Approved on objective and subjective sleepiness measures in narcolepsy, obstructive sleep apnoea and shift work disorder. In healthy non-sleep-deprived adults the pooled cognitive effect is a standardised mean difference of 0.12, significant but small, with memory updating the only domain reaching significance on its own.

No suggested links are held for this record, so nothing is hidden from this path.

What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.

What it would be like to takeRead from sources, not yet reviewed

Felt, measured, or meaningful

Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.

Felt

Things a person could notice without a test.

  • fatigue severity scale
  • fatigue
  • pain
  • cocaine craving
  • multidimensional fatigue inventory

Measured

Things only a test, a scale or a device shows.

  • urine toxicology for cocaine
  • increase in heart rate standing
  • urine toxicology
  • ma urine samples
  • heart rate
  • systolic blood pressure
  • diastolic blood pressure

Meaningful

Things that change how a life goes, not only a number.

  • cognitive performance

A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.

Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.

Measured, but not felt. A number moves. The person notices nothing. Both can be true.

Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.

Matters, but takes years. The result that counts may take longer than anyone would keep watching.

Names that fit none of the three (27)
  • primary efficacy variable was the mean apnea hypopnea index
  • cocaine abstinence
  • boost in language learning success through neuromodulation
  • adverse events
  • compliance
  • retention
  • cocaine use
  • sleep latency
  • epworth sleepiness scale
  • multiple sleep latency test
  • psychomotor vigilance task
  • cardiovascular
  • sedation
  • cognitive test scores at end of treatment period
  • abstinence
  • total sleep time
  • weight
  • bioequivalence
  • combined auc for selected symptoms
  • average daytime napping minutes in a week

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What it would be like to takeRead from sources, not yet reviewed

How long anything takes

Nine different lengths of time that get confused with each other. None of them is worked out from another.

  1. Before anything is noticed. RNAWiki does not store this separately, and never works it out from another figure on this page.

  2. Before a test result moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  3. Before performance moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  4. How long the result was watched. No finished study window is recorded for a study that tested this substance.

  5. How long people took it. How long people actually took it is not stored. The study window is not the same thing.

  6. How long people were followed. Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.

  7. How fast the body clears it. about 15 hours hours

    Read from the label, which states: “The effective elimination half-life of modafinil after multiple doses is about 15 hours.”

  8. How long effects linger. RNAWiki does not store this separately, and never works it out from another figure on this page.

  9. Beyond the studies. Nothing is recorded about the long term.

    The longest finished study sets the edge of what anyone measured.

A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • On label: adults with narcolepsy, sleep apnoea on CPAP, and shift workers. Off label: students, doctors, programmers, military personnel and anyone buying it online for focus, in doses and durations no trial has studied.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “Safety and effectiveness in pediatric patients have not been established.”

    US prescribing information · 5b8496fe-b647-4ce6-aeef-71245712e46f · read 2026-08-30

  • On older people, the label states: “In clinical trials, experience in a limited number of modafinil-treated patients who were greater than 65 years of age showed an incidence of adverse reactions similar to other age groups.”

    US prescribing information · 5b8496fe-b647-4ce6-aeef-71245712e46f · read 2026-08-30

  • On people who are pregnant, the label states: “Intrauterine growth restriction and spontaneous abortion have been reported in association with modafinil (a mixture of R-and S-modafinil) and armodafinil (the R-enantiomer of modafinil).”

    US prescribing information · 5b8496fe-b647-4ce6-aeef-71245712e46f · read 2026-08-30

  • On people who are breastfeeding, the label states: “It is not known whether modafinil or its metabolites are excreted in human milk.”

    US prescribing information · 5b8496fe-b647-4ce6-aeef-71245712e46f · read 2026-08-30

  • On people with reduced liver function, the label states: “In patients with severe hepatic impairment, the dose of modafinil should be reduced to one-half of that recommended for patients with normal hepatic function [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)] .”

    US prescribing information · 5b8496fe-b647-4ce6-aeef-71245712e46f · read 2026-08-30

Where the result stopped carrying

  • Modafinil is not approved for use in anyone under 17 for any indication, and the paediatric rash signal is the reason the label says so twice
  • The user perception of substantial cognitive enhancement is, in the meta-analysts own words, not supported by the evidence so far
  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied for a different goal

The studies measured something else entirely.

On this record: Some registered studies measured things that match no goal on this page.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Prescription only

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Oral tablet, 100 mg and 200 mg, once daily in the morning or one hour before a shift

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

RNAWiki has not recorded a supervision or regulatory status for this substance.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

No register row and no identity class settled the question.

No source is stored against this line.

What is in the pack

A simple immediate-release tablet. The approved regimens are once daily in the morning for narcolepsy and sleep apnoea, and one hour before the start of a shift for shift work disorder. Off-label use spans a wide dose range and indefinite duration, neither of which has been studied.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeRead from sources, not yet reviewed

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Worth asking a clinician aboutWritten into the record from the studies named on this page

Labelled warnings: serious rash including Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS, with discontinuation at the first sign of rash; angioedema and anaphylaxis; multi-organ hypersensitivity; persistent sleepiness with advice to avoid driving; psychiatric symptoms with caution in a history of psychosis, depression or mania; and increased monitoring in known cardiovascular disease. It induces CYP3A4, which reduces the effectiveness of hormonal contraception. Schedule IV, with documented reinforcing properties. The pregnancy position is Category C on the US label, with a series of registry and national cohort studies published since 2020 examining malformation risk.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

Reports sent to a regulator

  • These are reports people sent to a regulator. They do not show the medicine caused the reaction.
  • Nobody counted how many people took the medicine and reported nothing.
  • The same event can be reported more than once, and many reports are incomplete.
  • News coverage, lawsuits and new warnings change how often people report.
  • A count is not a rate and not a risk.

Modafinil appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 667 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • anxiety — 100 reaction mentions
  • drug interaction — 94 reaction mentions
  • somnolence — 91 reaction mentions
  • insomnia — 73 reaction mentions
  • depression — 62 reaction mentions
  • psychotic disorder — 55 reaction mentions
  • agitation — 49 reaction mentions
  • irritability — 49 reaction mentions
  • suicidal ideation — 49 reaction mentions
  • mania — 45 reaction mentions
  • open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Oral tablet, 100 mg and 200 mg, once daily in the morning or one hour before a shift

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

The approved regimens are once daily in the morning for narcolepsy and sleep apnoea, and one hour before the start of a shift for shift work disorder. Off-label use spans a wide dose range and indefinite duration, neither of which has been studied.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on which forms are sold and how they compare.

No source is stored against this line.

What is recorded as being sold

  • 76 products list this as an active ingredient in the United States drug directory. 76 of them contain it and nothing else.

    FDA National Drug Code directory · 0904-6791 · read 2026-08-29

  • They are sold as powder and tablet, taken oral.

    FDA National Drug Code directory · 0904-6791 · read 2026-08-29

  • The regulator's established pharmacologic class for it is central nervous system stimulation [pe], increased sympathetic activity [pe] and sympathomimetic-like agent [epc].

    FDA National Drug Code directory · 0904-6791 · read 2026-08-29

  • 35 published labels name it as an active ingredient. 35 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 5b8496fe-b647-4ce6-aeef-71245712e46f · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 5b8496fe-b647-4ce6-aeef-71245712e46f · read 2026-08-29

  • 1 marketed supplement label lists this ingredient, classed as other combinations.

    NIH Dietary Supplement Label Database · 318240 · read 2026-08-29

  • Those labels carry all other and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.

    NIH Dietary Supplement Label Database · 318240 · read 2026-08-29

  • Modafinil is tablets at Tablets: 100 mg and 200 mg, recorded as prescription product; fda label in effect 2026-07-14 in the United States.

    US prescribing information · 013450dd-cd42-46c7-98d6-9a2925761978 · read 2026-08-28

  • Recorded price in US: 0.24196–0.3483 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 42 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..

    Recorded source · 2026-08-26 · read 2026-08-28

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.

Questions worth asking

  • Which of the trials of Modafinil studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

Claims that go past the evidence

Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.

Goes past the evidence

That an effect size of 0.12 in laboratory tasks corresponds to a meaningful advantage in real work, which the meta-analysts explicitly decline to conclude

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That being non-amphetamine makes it free of abuse liability, when the label documents reinforcement in cocaine-trained primates and Schedule IV placement

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That approval for sleepiness implies safety or benefit for cognitive enhancement in healthy adults, an indication no regulator has assessed

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That two decades on the market without a controlled pregnancy study amounts to reassurance about pregnancy

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Modafinil are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Every line above can be traced to the study named beside it. Follow the link and read it.

It blocks half the striatal dopamine transporters at a normal dose
In plain words
Brain imaging in ten healthy men showed that 200 to 400 mg of modafinil occupied about half the dopamine transporters in the striatum and raised dopamine in the reward centre by about a fifth.
What was measured
Change in [11C]raclopride and [11C]cocaine binding potential in caudate, putamen and nucleus accumbens after 200 and 400 mg
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Volkow et al. used positron emission tomography with [11C]raclopride, sensitive to changes in endogenous dopamine, and [11C]cocaine, a dopamine transporter ligand, in 10 healthy male participants at Brookhaven National Laboratory over 2007-2008. Modafinil at therapeutic doses of 200 mg and 400 mg decreased [11C]raclopride binding potential by 6.1% in caudate (95% CI 1.5-10.8, P = .02), 6.7% in putamen (95% CI 3.2-10.3, P = .002) and 19.4% in nucleus accumbens (95% CI 5-35, P = .02), reflecting increased extracellular dopamine. It decreased [11C]cocaine binding potential by 53.8% in caudate (95% CI 43.9-63.6, P < .001), 47.2% in putamen (95% CI 39.1-55.4, P < .001) and 39.3% in nucleus accumbens (95% CI 30-49, P = .001), reflecting transporter occupancy. The authors concluded that because drugs raising dopamine in the nucleus accumbens have abuse potential, the results highlight a need for awareness of abuse and dependence in vulnerable populations.
Source
Volkow ND et al., JAMA 2009;301:1148-1154
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The pooled cognitive effect in healthy adults is 0.12
In plain words
A meta-analysis of 14 modafinil studies in healthy rested adults found an overall effect size of 0.12 — small — driven by a single narrow domain, memory updating.
What was measured
Standardised mean difference in cognitive performance against placebo, pooled across 14 modafinil studies and 64 effect sizes
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Roberts et al. ran three PRISMA-compliant meta-analyses of modafinil, methylphenidate and D-amphetamine against placebo in healthy non-sleep-deprived adults, with subgroup analysis by cognitive domain: executive functions, spatial working memory, recall, selective attention and sustained attention. For modafinil, 14 studies yielded 64 effect sizes and an overall standardised mean difference of 0.12 (p = .01), with the only significant domain being memory updating at SMD 0.28 (p = .03). Methylphenidate produced SMD 0.21 overall; D-amphetamine produced no effect at all. The authors conclude that effects are small, that the experiments do not reflect actual use in the wider population, and that the user perception of effectiveness is not supported by the evidence so far.
Source
Roberts CA et al., Eur Neuropsychopharmacol 2020;38:40-62
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
Whether it helps depends on which test you run
In plain words
A systematic review found that simple cognitive tests showed inconsistent results — including some evidence that modafinil worsens creative thinking — while more complex tests showed more consistent benefit.
What was measured
That the review demonstrates cognitive enhancement, when its own conclusion is that the effect observed depends heavily on the test paradigm chosen
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Battleday and Brem reviewed all primary English-language studies from January 1990 to December 2014 of modafinil in healthy non-sleep-deprived humans. With basic testing paradigms, most studies showed enhanced executive function, only half showed improvements in attention and in learning and memory, and a few reported impairments in divergent creative thinking. With more complex assessments, modafinil appeared to consistently enhance attention, executive function and learning. They found no preponderance of side effects or mood changes. Their central methodological point is that much of this literature relies on psychometric tests designed to detect deficits in ill populations rather than gains in healthy ones, which is why the same drug looks different depending on the battery. That is a statement about measurement, not a demonstration of benefit, and it cuts both ways.
Source
Battleday RM, Brem AK, Eur Neuropsychopharmacol 2015;25:1865-1881
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Serious rash: 0.8% discontinuation rate in the paediatric trials
In plain words
In children given modafinil in trials, 13 of 1,585 stopped because of rash, including one possible case of Stevens-Johnson syndrome. None of 380 children on placebo did.
What was measured
Incidence of rash resulting in discontinuation in paediatric trials, and reporting rate of SJS and TEN against background incidence
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Provigil label reports that in clinical trials the incidence of rash resulting in discontinuation was approximately 0.8% — 13 per 1,585 — in paediatric patients under 17, including one case of possible Stevens-Johnson syndrome and one apparent multi-organ hypersensitivity reaction, several associated with fever, vomiting or leukopenia. Median time to rash causing discontinuation was 13 days. No such cases occurred among 380 paediatric placebo recipients. Modafinil is not approved for use in paediatric patients for any indication. The label further states that rare cases of serious or life-threatening rash including SJS, toxic epidermal necrolysis and DRESS have been reported in adults and children in worldwide postmarketing experience, and that the reporting rate for TEN and SJS exceeds the background incidence, which is 1 to 2 cases per million person-years. No factor is known to predict who is at risk, and nearly all cases occurred within one to five weeks of starting.
Source
PROVIGIL (modafinil) tablets prescribing information, NDA 020717, section 5.1 Serious Rash including Stevens-Johnson Syndrome
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
A Schedule IV drug with measured reinforcing properties
In plain words
The label states modafinil produces euphoric effects typical of stimulants, is self-administered by monkeys previously trained on cocaine, and is a Schedule IV controlled substance.
What was measured
Self-administration in cocaine-trained primates, stimulant discrimination, and controlled substance scheduling
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Provigil label, section 9, records that modafinil is a Schedule IV controlled substance; that in humans it produces psychoactive and euphoric effects and alterations in mood, perception, thinking and feeling typical of other central nervous system stimulants; that it binds the dopamine reuptake site and increases extracellular dopamine without increasing dopamine release; that it is reinforcing, as shown by self-administration in monkeys previously trained to self-administer cocaine; and that in some studies it was partially discriminated as stimulant-like. Its abuse potential at 200, 400 and 800 mg was assessed against methylphenidate at 45 and 90 mg in an inpatient study in individuals experienced with drugs of abuse. The manufacturer own document is more candid about the pharmacological family this drug belongs to than most of the writing about it.
Source
PROVIGIL (modafinil) tablets prescribing information, NDA 020717, section 9 Drug Abuse and Dependence
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
A pregnancy safety question that opened after twenty years on the market
In plain words
Registry and national cohort studies published from 2020 onward examined malformation rates after modafinil exposure in early pregnancy, a question the original approval left open.
What was measured
That an absence of controlled pregnancy data on a long-marketed drug is the same as an absence of risk
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The US label still classifies modafinil as Pregnancy Category C and states that there are no adequate and well-controlled studies in pregnant women, that intrauterine growth restriction and spontaneous abortion have been reported in association with modafinil and armodafinil, and that developmental toxicity was observed in rats and rabbits at clinically relevant plasma exposures. Since 2020 a series of epidemiological studies have addressed the question directly: a Scandinavian registry analysis of births in Norway and Sweden, a cohort from the manufacturer own Provigil/Nuvigil pregnancy registry, a 14-year registry study of modafinil and armodafinil, and a French nationwide cohort. The direction of the field has been from an absence of data to an active safety question, which is the shape of a conclusion shift even where the individual studies disagree.
Source
Cesta CE et al., JAMA 2020;324:895-897; Kaplan S et al., JAMA Intern Med 2021;181:275-277; Kaplan S et al., Neurol Clin Pract 2025;15:e200551; Kaplan S et al., Drug Saf 2026 (French nationwide cohort)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim

How many documents were read

  • 34 documents were read for this substance.

    RNAWiki source record

  • 28 of them state the same halfLife, and they agree.

    RNAWiki source record

  • 28 of them state the same tMax, and they agree.

    RNAWiki source record

  • 34 of them state the same proteinBinding, and they agree.

    RNAWiki source record

  • 34 of them state the same volumeOfDistribution, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
R3UK8X3U3D
CAS registry number
68693-11-8
PubChem compound
4236
RxNorm concept
30125

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Not passed

    Safety mode resolved

    No register row and no identity class settled the question.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 14 approved applications cover products containing this substance. The earliest was NDA020717, approved 19981224 to NUVO PHARMS.

    Drugs@FDA application register · NDA020717 · read 2026-08-29

  • Marketing status on the register: discontinued, none (tentative approval) and prescription.

    Drugs@FDA application register · NDA020717 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19981224.

    FDA National Drug Code directory · 0904-6791 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

3 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

The older medicine-wide conclusion held in this record

Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.

A Schedule IV wakefulness drug that occupies more than half of striatal dopamine transporters at a therapeutic dose, improves cognition in healthy rested adults by a pooled standardised mean difference of 0.12, and carries a labelled rate of rash requiring discontinuation of 0.8% in children with one possible Stevens-Johnson case.

Recorded evidence blocks (15)

What did Modafinil's largest trial (7500 people) and its longest (33 years) measure?


7500 people in Modafinil's largest registered study, 33 years in its longest registered window, measuring Gross motor function measure (GMFM). ClinicalTrials.gov · 2026-09-01

49 phase2, 30 phase3, 27 phase1, 21 na, 21 phase4, 4 early phase1, 4 na or unstated; NCT00262470; 2029-12; no ageing endpoint recorded. Last human test completed 2026, NCT06404099.

Interpretation These counts include studies where Modafinil was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.

Show the evidence
  • phase2
    49
  • phase3
    30
  • phase1
    27
  • na
    21
  • phase4
    21
  • early phase1
    4
2 more recorded rows
  • na or unstated
    4
  • Last recorded human test NCT06404099
    2026-04-20

recorded 2026-09-01 · last checked 2026-09-04

Modafinil was tested only in human — what did it show?


human: healthspan (148): the rungs where Modafinil has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Gross motor function measure (GMFM) — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human healthspan
Show the evidence
  • human NCT05675098
    healthspan; Gross motor function measure (GMFM); 148

recorded 2026-09-01 · last checked 2026-09-04

18 of Modafinil's trials stopped: safety, accrual/recruitment, funding/business, sponsor decision unspecified, other?


safety (1), accrual/recruitment (9), funding/business (2), sponsor decision unspecified (1) and other (5): Modafinil's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"PI left institution, end of funding, clinic relocation, recruitment issues"; 18 of 148 registered studies

Show the evidence

Trial

  • NCT00218036
    terminated; "PI left institution, end of funding, clinic relocation, recruitment issues"
  • NCT00233090
    terminated; "Insufficient recruitment"
  • NCT00267332
    terminated; "Low accrual"
  • NCT00393562
    withdrawn; "Unable to recruit any subjects for this study"
  • NCT00396734
    suspended; "Grant was not renewed"
  • NCT00418691
    terminated; "Closed early due to slow accrual."
12 further recorded trials
  • NCT00591019
    terminated; "Terminated early due to lack of change in primary and secondary outcome measures."
  • NCT00838227
    withdrawn; "No source of funding to implement the study."
  • NCT00859573
    terminated; "Terminated due to lack of funding."
  • NCT01048983
    withdrawn; "No accrual."
  • NCT01348607
    terminated; "Study only randomized 1 subject and was determined not feasible by DSMB"
  • NCT01792583
    terminated; "The study is no longer feasible."
  • NCT01800097
    terminated; "Slow recruitment"
  • NCT01913327
    terminated; "Insufficient Funds and Inadequate Subject Recruitment"
  • NCT02028260
    withdrawn; "unable to enroll"
  • NCT02857244
    withdrawn; "Site did not obtain LIRB approval due to medication usage."
  • NCT03620253
    terminated; "Principal Investigator left study site"
  • NCT04317001
    withdrawn; "Researcher leading the study moved institutions study not feasible"

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Modafinil used Modafinil 200mg — over how long?


Human studies of Modafinil used "Modafinil 200mg". ClinicalTrials.gov · 2026-09-01

15 recorded entries; human; tablet; also "Modafinil 400mg", "PROVIGIL 200 mg", "Armodafinil 250 mg"

Show the evidence

human

  • NCT00218036
    Modafinil 200mg
  • NCT00218036
    Modafinil 400mg
  • NCT00236080
    PROVIGIL 200 mg
  • NCT00236080
    Armodafinil 250 mg
  • NCT00236080
    Armodafinil 200 mg
  • NCT00236080
    Armodafinil 150 mg
9 more recorded rows
  • human NCT00650000
    Modafinil Tablets 200 mg
  • human NCT00650000
    Provigil® Tablets 200 mg
  • human NCT01778010
    Modafinil 0 mg
  • human NCT01778010
    Modafinil 200 mg
  • human NCT01778010
    Modafinil 400 mg
  • human NCT02071615
    tablet; modafinil 200mg tablet given once by mouth
  • human NCT02376257
    100 mg Modafinil
  • human NCT02821715
    Modafinil 300 mg
  • human NCT03083132
    modafinil 50mg

recorded 2026-09-01 · last checked 2026-09-04

More Modafinil was worse in human: at what point?


U-shaped in human: "The dose-response curve for modafinil is U-shaped; feeding decreases after doses of 20 and 40 mg/kg, but no effects were seen after doses of 10 and 80 mg/kg. When feeding is resumed, no compensatory effect is seen, and body weight remains lower during the 24-h session." Europe PMC · dose-response search · 2019-08-16

5 recorded sentences naming Modafinil; U-shaped, dose-response, biphasic, dose response

Show the evidence
  • U-shaped PMID 8102316
    "The dose-response curve for modafinil is U-shaped; feeding decreases after doses of 20 and 40 mg/kg, but no effects were seen after doses of 10 and 80 mg/kg. When feeding is resumed, no compensatory effect is seen, and body weight remains lower during the 24-h session."

dose-response

  • PMID 31425678
    "Hyperactivity increased with a dose-response effect of modafinil in the PS group; meanwhile, this behavior increased only with the dose of 60 mg/kg in the PA group."
  • "In the PiezoSleep dose-response study, the ED 50 for wake-promotion by modafinil was approximately 50 mg/kg in both genotypes."
  • biphasic PMID 19663523
    "After reaching C(max), plasma concentrations appeared to decline in a monophasic manner with armodafinil, but in a biphasic manner with modafinil due to the initial rapid elimination of its S-isomer."
  • dose response
    "The solubility, dissolution, bioavailability, dose response, and stability of modafinil can be modulated to improve efficacy in pharmaceutical compositions."

recorded 2019-08-16 · last checked 2026-09-04

Modafinil's half-life is about 15 hours — which schedules were studied?


about 15 hours, the half-life Modafinil's label states. openfda-label · 944daf47-49a6-93ca-e348-4a0f1b6d937e · 2026-08-28

Show the evidence
  • half life
    about 15 hours hours; The effective elimination half-life of modafinil after multiple doses is about 15 hours.
  • tmax
    Food has no effect on overall modafinil tablets bioavailability; however, time to reach peak concentration (t max ) may be delayed by approximately one hour if taken with food.
  • bioavailability
    The bioavailability of modafinil tablets is approximately equal to that of an aqueous suspension.
  • metabolism
    Auto-induction of metabolizing enzymes, most importantly cytochrome P-450 CYP3A4, has also been observed in vitro after incubation of primary cultures of human hepatocytes with modafinil and in vivo after extended administration of modafinil at 400 mg/day.

recorded 2026-08-28 · last checked 2026-09-04

Could one person measure Modafinil's effect on primary efficacy variable was the mean apnea hypopnea index?


Primary efficacy variable was the mean apnea hypopnea index: measured in Modafinil's trials.

Interpretation primary efficacy variable was the mean apnea hypopnea index is the recorded endpoint.

Show the evidence

biomarkers

  • primary efficacy variable was the mean apnea hypopnea index; 2026-09-01
  • cocaine abstinence; 2026-09-01
  • boost in language learning success through neuromodulation; 2026-09-01
  • fatigue severity scale; 2026-09-01
  • adverse events; 2026-09-01
  • compliance; 2026-09-01
14 more recorded rows
  • biomarkers
    retention; 2026-09-01
  • biomarkers
    urine toxicology for cocaine; 2026-09-01
  • biomarkers
    cocaine use; 2026-09-01
  • biomarkers
    sleep latency; 2026-09-01
  • biomarkers
    epworth sleepiness scale; 2026-09-01
  • biomarkers
    fatigue; 2026-09-01
  • biomarkers
    multiple sleep latency test; 2026-09-01
  • biomarkers
    psychomotor vigilance task; 2026-09-01
  • biomarkers
    increase in heart rate standing; 2026-09-01
  • biomarkers
    cardiovascular; 2026-09-01
  • biomarkers
    sedation; 2026-09-01
  • biomarkers
    pain; 2026-09-01
  • biomarkers
    cognitive test scores at end of treatment period; 2026-09-01
  • biomarkers
    urine toxicology; 2026-09-01
  • half life
    2026-09-04; halfLife; hours; about 15 hours; 2026-08-28
  • human trials at or under30
    57
  • smallest human trial
    0; NCT00393562; NA; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN

Which of abstinence, adverse events and average daytime napping minutes in a week did Modafinil's trials measure?


abstinence, adverse events and average daytime napping minutes in a week lead 40 outcome terms across Modafinil's trials. ClinicalTrials.gov · 2026-09-01

Interpretation fatigue severity scale, adverse events, compliance, retention, urine toxicology for cocaine and cocaine use follow.

Show the evidence
  • primary efficacy variable was the mean apnea hypopnea index
    1
  • cocaine abstinence
    1
  • boost in language learning success through neuromodulation
    1
  • fatigue severity scale
    1
  • adverse events
    1
  • compliance
    1
14 more recorded rows
  • retention
    1
  • urine toxicology for cocaine
    1
  • cocaine use
    1
  • sleep latency
    1
  • epworth sleepiness scale
    1
  • fatigue
    1
  • multiple sleep latency test
    1
  • psychomotor vigilance task
    1
  • increase in heart rate standing
    1
  • cardiovascular
    1
  • sedation
    1
  • pain
    1
  • cognitive test scores at end of treatment period
    1
  • urine toxicology
    1

recorded 2026-09-01 · last checked 2026-09-04

Which of Modafinil's 11 ongoing trials reports first?


11 registered trials of Modafinil are open; earliest completion 2026-12. ClinicalTrials.gov · 2026-09-01

Increase in heart rate with standing; Visual Attention Performance Speed; latest 2033-03-01

Show the evidence

Trial

  • NCT00262470
    "Treatment of Orthostatic Intolerance"; n 150; "Increase in heart rate with standing"; 2029-12
  • NCT01988883
    "Modafinil and Cognitive Function in POTS"; n 20; "Visual Attention Performance Speed"; 2026-12
  • NCT05333250
    "Modafinil to Improve Fatiguability"; n 40; "Fatigue"; 2028-03
  • NCT05675098
    "Central Nervous System Stimulants and Physical Function in Children With Cerebral Palsy"; n 30; "Gross motor function measure (GMFM)"; 2027-02-01
  • NCT06041048
    "Investigation of Locus Coeruleus Function in Sustained Attention"; n 40; "Brain activity - BOLD response"; 2026-12-19
  • NCT06354985
    "Modafinil and Exercise for Post Stroke Fatigue"; n 212; "Severity of Fatigue Symptoms"; 2027-09
5 further recorded trials
  • NCT07231497
    "Cognitive Strategies in Early Psychosis 1"; n 103; "Test My Brain - Digit Symbol Coding"; 2030-04-30
  • NCT07263022
    "Cognitive Strategies in Early Psychosis 2"; n 24; "Test My Brain - Digit Symbol Coding"; 2030-04-30
  • NCT07295834
    "Modafinil For Fatigue in IBD: A Feasibility Randomised Controlled Trial"; n 70; "Recruitment rate"; 2028-02-01
  • NCT07568574
    "Impact of Medically Supervised Performance-Enhancing Substances (PES) on Elite Athletes"; n 60; "The incidence and severity of Treatment-related adverse events (TRAEs), including adverse events (AEs) and serious adverse events (SAEs), as assessed by the study physicians from baseline to 5.5 years after enrollment."; 2033-03-01
  • NCT07582458
    "Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease MODIFI-IBD Trial)"; n 60; "The mean difference in section I of the IBD-F questionnaire at week 8"; 2027-06

recorded 2026-09-01 · last checked 2026-09-04

Which 54 trials of Modafinil posted no result?


Posted no result
54 of 54 completed trials
Registrations
NCT00650000, NCT00650286, NCT00208715, NCT00702637, NCT00215176 and NCT00107796, and 48 more
Completion dates
oldest 2002-10; newest 2024-07-16
Show the evidence

Trial

  • NCT00650000
    2002-10
  • NCT00650286
    2002-10
  • NCT00208715
    2004-10
  • NCT00702637
    2005-03
  • NCT00215176
    2005-04
  • NCT00107796
    2005-09
14 further recorded trials
  • NCT00107809
    2005-09
  • NCT00107848
    2005-09
  • NCT00214968
    2005-10
  • NCT00178373
    2006-03
  • NCT00142402
    2006-09
  • NCT00214981
    2006-09
  • NCT00228540
    2006-09
  • NCT00343811
    2006-09
  • NCT00100100
    2006-12
  • NCT00315276
    2007-01
  • NCT00344565
    2007-03
  • NCT00895570
    2007-04
  • NCT00124384
    2007-08
  • NCT00636896
    2007-08

At the median, Modafinil's trials enrolled 41 people — anything larger?


Median enrolment
41
Largest enrolment
7500
Registered trials counted
145

What do 667 spontaneous reports say about Modafinil — and not say?


These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Modafinil appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 667 reaction mentions were counted: anxiety 100; drug interaction 94; somnolence 91; insomnia 73. open-targets-adr · CHEMBL1373 · 2026-06-24

Show the evidence
  • anxiety
    100
  • drug interaction
    94
  • somnolence
    91
  • insomnia
    73
  • depression
    62
  • psychotic disorder
    55
4 more recorded rows
  • agitation
    49
  • irritability
    49
  • suicidal ideation
    49
  • mania
    45

recorded 2026-06-24 · last checked 2026-09-04

Modafinil and CYP2C19, CYP3A4 and CYP1A2: shared by which compounds?


CYP2C19, CYP3A4 and CYP1A2 appear in Modafinil's recorded interaction sentences, 16 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics

Show the evidence

CYP1A2

  • pharmacokinetics
    Drug Interactions In vitro data demonstrated that modafinil weakly induces CYP1A2, CYP2B6, and possibly CYP3A activities in a concentration-related manner and that CYP2C19 activity is reversibly inhibited by modafinil.
  • pharmacokinetics
    Quetiapine -In a separate clinical study, concomitant administration of armodafinil 250 mg with quetiapine (300 mg to 600 mg daily doses) resulted in a reduction in the mean systemic exposure of quetiapine by approximately 29%. · Drugs Metabolized by CYP1A2 In vitro data demonstrated that modafinil is a weak inducer of CYP1A2 in a concentration-related manner.
  • CYP2B6 pharmacokinetics
    Drug Interactions In vitro data demonstrated that modafinil weakly induces CYP1A2, CYP2B6, and possibly CYP3A activities in a concentration-related manner and that CYP2C19 activity is reversibly inhibited by modafinil.

CYP2C19

  • pharmacokinetics
    Drug Interactions In vitro data demonstrated that modafinil weakly induces CYP1A2, CYP2B6, and possibly CYP3A activities in a concentration-related manner and that CYP2C19 activity is reversibly inhibited by modafinil.
  • pharmacokinetics
    In tricyclic-treated patients deficient in CYP2D6 (i.e., those who are poor metabolizers of debrisoquine; 7 to 10% of the Caucasian population; similar or lower in other populations), the amount of metabolism by CYP2C19 may be substantially increased.
  • pharmacokinetics
    However, since only a single dose of warfarin was tested in this study, an interaction cannot be ruled out [see Drug Interactions (7)] . · Drugs Metabolized by CYP2C19 In vitro data demonstrated that modafinil is a reversible inhibitor of CYP2C19 activity.
  • pharmacokinetics
    CYP2C19 is also reversibly inhibited, with similar potency, by a circulating metabolite, modafinil sulfone.
  • pharmacokinetics
    CYP2C19 also provides an ancillary pathway for the metabolism of certain tricyclic antidepressants (e.g., clomipramine and desipramine) and selective serotonin reuptake inhibitors that are primarily metabolized by CYP2D6.
  • pharmacokinetics
    Therefore, exposure to some drugs that are substrates for CYP2C19 (e.g., phenytoin, diazepam, propranolol, omeprazole, and clomipramine) may be increased when used concomitantly with modafinil [see Drug Interactions (7)] .
  • CYP2C9 pharmacokinetics
    In vitro data also demonstrated that modafinil produced an apparent concentration-related suppression of expression of CYP2C9 activity.

CYP2D6

  • pharmacokinetics
    In tricyclic-treated patients deficient in CYP2D6 (i.e., those who are poor metabolizers of debrisoquine; 7 to 10% of the Caucasian population; similar or lower in other populations), the amount of metabolism by CYP2C19 may be substantially increased.
  • pharmacokinetics
    CYP2C19 also provides an ancillary pathway for the metabolism of certain tricyclic antidepressants (e.g., clomipramine and desipramine) and selective serotonin reuptake inhibitors that are primarily metabolized by CYP2D6.

CYP3A4

  • pharmacokinetics
    However, due to the partial involvement of CYP3A enzymes in the metabolic elimination of modafinil, coadministration of potent inducers of CYP3A4/5 (e.g., carbamazepine, phenobarbital, rifampin) or inhibitors of CYP3A4/5 (e.g., ketoconazole, erythromycin) could alter the plasma concentrations of modafinil.
  • pharmacokinetics
    The Potential of Modafinil to Alter the Metabolism of Other Drugs by Enzyme Induction or Inhibition · Drugs Metabolized by CYP3A4/5 In vitro data demonstrated that modafinil is a weak inducer of CYP3A activity in a concentration-related manner.
  • pharmacokinetics
    Auto-induction of metabolizing enzymes, most importantly cytochrome P-450 CYP3A4, has also been observed in vitro after incubation of primary cultures of human hepatocytes with modafinil and in vivo after extended administration of modafinil at 400 mg/day.
  • pharmacokinetics
    Cyclosporine -One case of an interaction between modafinil and cyclosporine, a substrate of CYP3A4, has been reported in a 41 year old woman who had undergone an organ transplant.

recorded 2026-08-30 · last checked 2026-09-04

Was Modafinil studied with exercise?


exercise is named in Modafinil's label sentences: "We included one pharmacological (modafinil) study and three non-pharmacological studies (resistance exercise, respiratory exercise, and repetitive transcranial magnetic stimulation (rTMS)), involving a total of 86 participants with ALS/MND." openfda-label+europepmc · 2026-08-30

1 recorded statement; exercise

Show the evidence
  • exercise
    We included one pharmacological (modafinil) study and three non-pharmacological studies (resistance exercise, respiratory exercise, and repetitive transcranial magnetic stimulation (rTMS)), involving a total of 86 participants with ALS/MND.

recorded 2026-08-30 · last checked 2026-09-04

What is recorded about Modafinil and mTOR?


"Modafinil improved learning and memory in sleep-deprived mice, associated with the inhibition of excessive autophage and apoptosis and an enhanced activation of the PI3K/Akt/mTOR/P70S6K signalling pathway in hippocampal neurons." — where Modafinil and mTOR appear together. Europe PMC · pathway abstract search · 2019-04-02

mTOR, autophagy; PMID 30767208

Show the evidence
  • mTOR PMID 30767208
    "Modafinil improved learning and memory in sleep-deprived mice, associated with the inhibition of excessive autophage and apoptosis and an enhanced activation of the PI3K/Akt/mTOR/P70S6K signalling pathway in hippocampal neurons."
  • autophagy PMID 30767208
    "Modafinil improved learning and memory in sleep-deprived mice, associated with the inhibition of excessive autophage and apoptosis and an enhanced activation of the PI3K/Akt/mTOR/P70S6K signalling pathway in hippocampal neurons."

recorded 2019-04-02 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1373
PubChem CID
11173366
CAS number
112111-47-4
RxCUI
30125
InChIKey
YFGHCGITMMYXAQ-UHFFFAOYSA-N
Development code
CEP 1538, CRC-40476, CRL 40476, DEP-1538, MODAFINIL COMPONENT OF THN-102, MODAFINIL COMPONENT OF THN102, NSC-751178, NSC-759110
Also called
Modafinil civ, Modafinilo, Modaphonil, Modiodal, alertec, vigil, MODAFINIL CIV [USP-RS], MODAFINIL [EP MONOGRAPH], MODAFINIL [HSDB], MODAFINIL [JAN]
Trade name
Provigil, Provigil; Alertec, Modiodal and Modavigil outside the United States
Sources (10)

Sources

4 more sources
  • open-targets-adr CHEMBL1373 ·
  • openfda-label 944daf47-49a6-93ca-e348-4a0f1b6d937e ·
  • openfda-label+europepmc K1:R3UK8X3U3D ·
  • national registers US, CA ·

ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 10 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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