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Armodafinil

  • 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 Armodafinil does in the body

Wakefulness

From the FDA-approved label: The mechanism(s) through which armodafinil promotes wakefulness is unknown. Armodafinil (R-modafinil) has pharmacological properties similar to those of modafinil (a mixture of R- and S-modafinil), to the extent tested in animal and in vitro studies. The R- ‑and S-enantiomers have similar pharmacological actions in animals. Armodafinil and modafinil have wake-promoting actions similar to sympathomimetic agents including amphetamine and methylphenidate, although their pharmacologic profile is not identical to that of the sympathomimetic amines.

What happened in people

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

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · V63XWA605I · read 2026-08-29

  • Its recorded molecular formula is C15H15NO2S, weighing 273.35.

    US prescribing information · 93b9f9a4-66d9-4ed9-8f2f-903e416e900d · read 2026-08-30

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

No statement of the main limit is recorded.

The four opening statements run to 91 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.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

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.

Formulation

A formulation is the exact made-up form a substance comes in.

A picture of it, and where the picture fails

It is like the difference between a whole bean and instant coffee.

Where that stops being true. Coffee tastes different. A formulation can change how much reaches the blood.

What people get wrong. Two products with the same name are assumed to behave the same. They often do not.

The specific composition and physical form of a product, including salt, excipients and release profile.

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 20 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
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.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.
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 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
Sleep
multiple sleep latency test; insomnia severity index
Energy
brief fatigue inventory

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
1 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.

Participants With Treatment-Emergent Adverse Events (TEAE)

The study did not show it

Who was studied
NCT01121536
How many people
867
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. 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

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Safety and Tolerability in This Patient Population (Narcolepsy, OSAHS, SWSD) Over Time (up to 2 Years)

The study did not show it

Who was studied
NCT00228553
How many people
743
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. 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

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

The study did not show it

Who was studied
NCT01072630
How many people
492
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. 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

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

The study did not show it

Who was studied
NCT01072929
How many people
433
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. 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

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Mean Sleep Latency (Minutes) From the Multiple Sleep Latency Test (MSLT)- Average of Four Scheduled Naps Across Days 1 and 2

The study did not show it

Who was studied
NCT00758498
How many people
427
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. 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

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)

The study did not show it

Who was studied
NCT01305408
How many people
399
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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. 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

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 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 No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life Evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.3 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.2 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 No evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
  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 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.

  • clinical global impression of change
  • brief fatigue inventory
  • insomnia severity index

Measured

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

  • apparent total plasma clearance
  • maximum observed plasma drug concentration

Meaningful

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

No registered study measured anything of this kind.

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 (15)
  • maintenance of wakefulness test
  • multiple sleep latency test
  • psychomotor vigilance task
  • adverse events
  • retention
  • adherence
  • combined auc for selected symptoms
  • treatment emergent adverse events
  • symbol digit modalities test
  • treatment effects on 5 selected symptoms
  • terminal half life
  • terminal elimination rate constant
  • apparent volume of distribution
  • incidence of major birth defects
  • epworth sleepiness scale

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. 4 hours hours

    Read from the label, which states: “However, the C max and AUC 0-∞ , of armodafinil at steady-state were approximately 37% and 70% higher, respectively, following administration of 200 mg armodafinil than the corresponding values of modafinil following administration of 200 mg modafinil due to the more rapid clearance of the S-enantiomer (elimination half-life approximately 4 hours) as compared to the R-enantiomer.”

  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.

  • Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.

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 · 93b9f9a4-66d9-4ed9-8f2f-903e416e900d · read 2026-08-30

  • On older people, the label states: “In elderly patients, elimination of armodafinil and its metabolites may be reduced as a consequence of aging.”

    US prescribing information · 93b9f9a4-66d9-4ed9-8f2f-903e416e900d · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Limited available data on armodafinil use in pregnant women are insufficient to inform a drug associated risk of adverse pregnancy outcomes.”

    US prescribing information · 93b9f9a4-66d9-4ed9-8f2f-903e416e900d · read 2026-08-30

  • On people who are breastfeeding, the label states: “8.3 Females and Males of Reproductive Potential The effectiveness of hormonal contraceptives may be reduced when used with armodafinil and for one month after discontinuation of therapy.”

    US prescribing information · 93b9f9a4-66d9-4ed9-8f2f-903e416e900d · read 2026-08-30

  • On people with reduced liver function, the label states: “The dosage of armodafinil should be reduced in patients with severe hepatic impairment [see and Clinical Pharmacology (12.3) ] .”

    US prescribing information · 93b9f9a4-66d9-4ed9-8f2f-903e416e900d · read 2026-08-30

Where the result stopped carrying

  • 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.

A different form was studied

The studied form is not the form on the shelf.

On this record: This record is linked to 1 related forms. Evidence does not carry across all of them.

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 (9)
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

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

Sold as tablet, given by the oral route.

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 takeNothing found in the sources checked

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.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

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.

Armodafinil appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 840 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • rash — 172 reaction mentions
  • headache — 145 reaction mentions
  • anxiety — 118 reaction mentions
  • insomnia — 89 reaction mentions
  • somnolence — 65 reaction mentions
  • palpitations — 55 reaction mentions
  • depression — 52 reaction mentions
  • feeling abnormal — 50 reaction mentions
  • tremor — 49 reaction mentions
  • blood pressure increased — 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

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 53 products list this as an active ingredient in the United States drug directory. 53 of them contain it and nothing else.

    FDA National Drug Code directory · 52562-039 · read 2026-08-29

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

    FDA National Drug Code directory · 52562-039 · read 2026-08-29

  • 16 published labels name it as an active ingredient. 16 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · facd329b-1925-61df-e053-6294a90ab738 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · facd329b-1925-61df-e053-6294a90ab738 · read 2026-08-29

  • Armodafinil is oral at 3 DOSAGE FORMS AND STRENGTHS • Armodafinil Tablets, 50 mg are white to off-white, round shaped uncoated tablets debossed with ‘K’ on one side and ‘58’ on the other side. • Armodafinil Tablets, 150 mg are white to off-wh…, recorded as fda label in effect 2026-03-06 in the United States.

    US prescribing information · 93b9f9a4-66d9-4ed9-8f2f-903e416e900d · read 2026-08-30

  • Recorded price in US: 0.30418–0.92258 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 16 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.

Names and forms linked to this record

  • Racemate of

    Modafinil

    Evidence on this page does not automatically apply to this one.

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 Armodafinil 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

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 Armodafinil 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.

How many documents were read

  • 16 documents were read for this substance.

    RNAWiki source record

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

    RNAWiki source record

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

    RNAWiki source record

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

    RNAWiki source record

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

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
V63XWA605I
RxNorm concept
724863

Checks this page had to pass

  • Passed

    Identity resolved

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  • Passed

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    no quarantine open

  • Passed

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    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.

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    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

  • 8 approved applications cover products containing this substance. The earliest was NDA021875, approved 20070615 to NUVO PHARMS.

    Drugs@FDA application register · NDA021875 · read 2026-08-29

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

    Drugs@FDA application register · NDA021875 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20060727.

    FDA National Drug Code directory · 52562-039 · 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

5 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.

  • The path through the body — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • Claims that go past the evidence — 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.

Recorded evidence blocks (11)

What did Armodafinil's largest trial (867 people) and its longest (14 years) measure?


867 people in Armodafinil's largest registered study, 14 years in its longest registered window, measuring Maximum observed plasma drug concentration (Cmax) by inspection. ClinicalTrials.gov · 2026-09-01

19 phase2, 19 phase3, 10 phase4, 6 phase1, 5 na, 1 na or unstated; NCT01792583; 2023-11-30; no ageing endpoint recorded. Last human test completed 2022, NCT01330446.

Interpretation These counts include studies where Armodafinil 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
    19
  • phase3
    19
  • phase4
    10
  • phase1
    6
  • na
    5
  • na or unstated
    1
1 more recorded row
  • Last recorded human test NCT01330446
    2022-12-08

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

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


human: biomarker (53): the rungs where Armodafinil has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Maximum observed plasma drug concentration (Cmax) by inspection — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human biomarker
Show the evidence
  • human NCT01624480
    biomarker; Maximum observed plasma drug concentration (Cmax) by inspection; 53

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

10 of Armodafinil's trials stopped: safety, accrual/recruitment, sponsor decision unspecified, other?


safety (1), accrual/recruitment (4), sponsor decision unspecified (2) and other (3): Armodafinil's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Study has been stopped by sponsor decision."; 10 of 53 registered studies

Show the evidence

Trial

  • NCT00893789
    terminated; "Study has been stopped by sponsor decision."
  • NCT00983437
    terminated; "Study has been stopped by sponsor decision"
  • NCT01048983
    withdrawn; "No accrual."
  • NCT01121536
    terminated; "Business decision related to efficacy rather than tolerability limitations, not stopped for any safety reasons."
  • NCT01169753
    terminated; "Slow Enrollment"
  • NCT01219673
    terminated; "Low accrual."
4 further recorded trials
  • NCT01256905
    withdrawn; "PI departure from institution"
  • NCT01400958
    terminated; "Slow Accrual, Initiating Principal Investigator (PI) left Moffitt"
  • NCT01470651
    terminated; "European Medicines Agency issued a drug/drug interaction: sofosbuvir/modafinil"
  • NCT01792583
    terminated; "The study is no longer feasible."

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

Human studies of Armodafinil used Armodafinil 250 mg/day — over how long?


Human studies of Armodafinil used "Armodafinil 250 mg/day". ClinicalTrials.gov · 2026-09-01

7 recorded entries; human; also "Armodafinil 150 mg/day", "Armodafinil 250 mg", "Armodafinil 200 mg"

Show the evidence

human

  • NCT00078325
    Armodafinil 250 mg/day
  • NCT00078325
    Armodafinil 150 mg/day
  • NCT00236080
    Armodafinil 250 mg
  • NCT00236080
    Armodafinil 200 mg
  • NCT00236080
    Armodafinil 150 mg
  • NCT01781468
    armodafinil 150 mg
1 more recorded row
  • human NCT01781468
    armodafinil 250 mg

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

Armodafinil's half-life is 4 hours — which schedules were studied?


4 hours, the half-life Armodafinil's label states. openfda-label · 4128759d-ed7c-4130-b24c-a0541f2b9e7f · 2026-08-30

Show the evidence
  • half life
    4 hours hours; However, the C max and AUC 0-∞ , of armodafinil at steady-state were approximately 37% and 70% higher, respectively, following administration of 200 mg armodafinil than the corresponding values of modafinil following administration of 200 mg modafinil due to the more rapid clearance of the S-enantiomer (elimination half-life approximately 4 hours) as compared to the R-enantiomer.
  • tmax
    Food effect on the overall bioavailability of armodafinil is considered minimal; however, time to reach peak concentration (t max ) may be delayed by approximately 2 to 4 hours in the fed state.
  • bioavailability
    The absolute oral bioavailability was not determined due to the aqueous insolubility of armodafinil, which precluded intravenous administration.
  • metabolism
    The oral clearance of armodafinil is approximately 33 mL/min. Metabolism In vitro and in vivo data show that armodafinil undergoes hydrolytic deamidation, S-oxidation, and aromatic ring hydroxylation, with subsequent glucuronide conjugation of the hydroxylated products.

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

Could one person measure Armodafinil's effect on maintenance of wakefulness test?


Maintenance of wakefulness test: measured in Armodafinil's trials.

Interpretation maintenance of wakefulness test is the recorded endpoint.

Show the evidence

biomarkers

  • maintenance of wakefulness test; 2026-09-01
  • clinical global impression of change; 2026-09-01
  • multiple sleep latency test; 2026-09-01
  • psychomotor vigilance task; 2026-09-01
  • brief fatigue inventory; 2026-09-01
  • insomnia severity index; 2026-09-01
14 more recorded rows
  • biomarkers
    adverse events; 2026-09-01
  • biomarkers
    retention; 2026-09-01
  • biomarkers
    adherence; 2026-09-01
  • biomarkers
    combined auc for selected symptoms; 2026-09-01
  • biomarkers
    treatment emergent adverse events; 2026-09-01
  • biomarkers
    symbol digit modalities test; 2026-09-01
  • biomarkers
    treatment effects on 5 selected symptoms; 2026-09-01
  • biomarkers
    terminal half life; 2026-09-01
  • biomarkers
    terminal elimination rate constant; 2026-09-01
  • biomarkers
    apparent total plasma clearance; 2026-09-01
  • biomarkers
    apparent volume of distribution; 2026-09-01
  • biomarkers
    maximum observed plasma drug concentration; 2026-09-01
  • biomarkers
    incidence of major birth defects; 2026-09-01
  • biomarkers
    epworth sleepiness scale; 2026-09-01
  • half life
    2026-09-04; halfLife; hours; 4 hours; 2026-08-30
  • human trials at or under30
    16
  • smallest human trial
    0; NCT01044004; NA; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN

Which of adherence, adverse events and apparent total plasma clearance did Armodafinil's trials measure?


adherence, adverse events and apparent total plasma clearance lead 20 outcome terms across Armodafinil's trials. ClinicalTrials.gov · 2026-09-01

Interpretation psychomotor vigilance task, brief fatigue inventory, insomnia severity index, adverse events, retention and adherence follow.

Show the evidence
  • maintenance of wakefulness test
    1
  • clinical global impression of change
    1
  • multiple sleep latency test
    1
  • psychomotor vigilance task
    1
  • brief fatigue inventory
    1
  • insomnia severity index
    1
14 more recorded rows
  • adverse events
    1
  • retention
    1
  • adherence
    1
  • combined auc for selected symptoms
    1
  • treatment emergent adverse events
    1
  • symbol digit modalities test
    1
  • treatment effects on 5 selected symptoms
    1
  • terminal half life
    1
  • terminal elimination rate constant
    1
  • apparent total plasma clearance
    1
  • apparent volume of distribution
    1
  • maximum observed plasma drug concentration
    1
  • incidence of major birth defects
    1
  • epworth sleepiness scale
    1

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

Which 5 trials of Armodafinil posted no result?


Posted no result
5 of 5 completed trials
Registrations
NCT00555347, NCT01010789, NCT01019187, NCT01624480 and NCT02468856
Completion dates
oldest 2011-08; newest 2017-11-30
Show the evidence

Trial

  • NCT00555347
    2011-08
  • NCT01010789
    2015-05
  • NCT01019187
    2015-08
  • NCT01624480
    2015-12
  • NCT02468856
    2017-11-30

At the median, Armodafinil's trials enrolled 60 people — anything larger?


Median enrolment
60
Largest enrolment
867
Registered trials counted
53

What do 840 spontaneous reports say about Armodafinil — 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.

Armodafinil appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 840 reaction mentions were counted: rash 172; headache 145; anxiety 118; insomnia 89. open-targets-adr · CHEMBL1201192 · 2026-06-24

Show the evidence
  • rash
    172
  • headache
    145
  • anxiety
    118
  • insomnia
    89
  • somnolence
    65
  • palpitations
    55
4 more recorded rows
  • depression
    52
  • feeling abnormal
    50
  • tremor
    49
  • blood pressure increased
    45

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

Armodafinil and CYP1A2, CYP2C19 and P-GLYCOPROTEIN: shared by which compounds?


CYP1A2, CYP2C19 and P-GLYCOPROTEIN appear in Armodafinil's recorded interaction sentences, 8 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics

Show the evidence

CYP1A2

  • pharmacokinetics
    Drug Interactions In vitro data demonstrated that armodafinil weakly induces CYP1A2 and possibly CYP3A activities in a concentration-related manner and that CYP2C19 activity is reversibly inhibited by armodafinil.
  • pharmacokinetics
    However, in a clinical study using caffeine as a probe substrate, no significant effect on CYP1A2 activity was observed. • Drugs Metabolized by CYP2C19 In vitro data demonstrated that armodafinil is a reversible inhibitor of CYP2C19 activity.
  • pharmacokinetics
    No dose adjustment is required. • Drugs Metabolized by CYP1A2 In vitro data demonstrated that armodafinil is a weak inducer of CYP1A2 in a concentration-related manner.

CYP2C19

  • pharmacokinetics
    Drug Interactions In vitro data demonstrated that armodafinil weakly induces CYP1A2 and possibly CYP3A activities in a concentration-related manner and that CYP2C19 activity is reversibly inhibited by armodafinil.
  • pharmacokinetics
    However, in a clinical study using caffeine as a probe substrate, no significant effect on CYP1A2 activity was observed. • Drugs Metabolized by CYP2C19 In vitro data demonstrated that armodafinil is a reversible inhibitor of CYP2C19 activity.
  • pharmacokinetics
    In a clinical study, concomitant administration of armodafinil 400 mg resulted in a 40% increase in exposure to omeprazole after a single oral dose (40 mg), as a result of moderate inhibition of CYP2C19 activity [see ] . • Interactions with CNS Active Drugs Concomitant administration of armodafinil with quetiapine reduced the systemic exposure of quetiapine.

CYP3A4

  • pharmacokinetics
    However, due to the partial involvement of CYP3A enzymes in the metabolic elimination of armodafinil, 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 armodafinil.
  • pharmacokinetics
    The Potential of Armodafinil to Alter the Metabolism of Other Drugs by Enzyme Induction or Inhibition • Drugs Metabolized by CYP3A4/5 In vitro data demonstrated that armodafinil is a weak inducer of CYP3A activity in a concentration-related manner.

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

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201192
PubChem CID
9690109
CAS number
112111-43-0
RxCUI
641465
InChIKey
YFGHCGITMMYXAQ-LJQANCHMSA-N

Relations

Also called
Armodafinilo, Modafinil, (r)-, R-(-)-modafinil, ARMODAFINIL [MART.], ARMODAFINIL [ORANGE BOOK], ARMODAFINIL [USAN], ARMODAFINIL [USP-RS], ARMODAFINIL [VANDF], ARMODAFINIL [WHO-DD]
Development code
CEP-10952, CEP-10953, CRL-40982, NSC-751850, NSC-758711
Trade name
Nuvigil
Sources (9)

Sources

3 more sources
  • openfda-label 4128759d-ed7c-4130-b24c-a0541f2b9e7f ·
  • openfda-label+europepmc K1:V63XWA605I ·
  • national registers US ·

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: 9 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

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.