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Sertraline

  • 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 Sertraline does in the body

Sertraline blocks the vacuum for one messenger, serotonin, so more of it stays in the gap for longer.

Nerve cells talk to each other by releasing a chemical messenger into the gap between them, and then vacuuming most of it back up to reuse. What happens next is not well understood: the blockade is complete within hours, but the mood change, when it comes, takes weeks. Whatever the drug is actually doing, it is not simply topping up a chemical that was low.

Why people take it. Used for depression, anxiety disorders and obsessive-compulsive disorder.

What happened in people

Across many studies, sertraline worked better than a dummy pill and people were relatively likely to keep taking it.

Reviewed first-read answer

Where this came from

A person wrote this and a reviewer approved it against this exact record. It carries no effect size.

A reviewer approved this against this record. The reviewed-claim record carrying the exact population and effect size does not exist yet.

No source is stored against this line.

The limit that matters most

Average benefit is smaller in people whose depression is not very severe.

Where it acts
Presynaptic serotonergic terminals, raphe nuclei and cortical projections
Kind of result
The kind of result is not recorded
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • Its recorded molecular formula is C17H17NCl2·HCl, weighing 342.7.

    US prescribing information · 4ddfd698-3d47-fc0e-e063-6394a90accec · 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.

A reviewer approved this sentence against this exact record and its sources.

The limit a reviewer approved as the one that matters most here.

The four opening statements run to 110 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.

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.

Pathway

A pathway is a chain of steps inside a cell, each one setting off the next.

A picture of it, and where the picture fails

A pathway is like a row of dominoes.

Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.

What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.

An ordered series of molecular interactions producing a defined cellular change.

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
MoodNothing 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 reviewer11 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.
Blood sugarNothing 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.Only a number moved1 registered test measure.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
Mood
hamilton rating scale for depression range; depression symptoms; state anxiety; liebowitz social anxiety scale; hamilton depression scale; montgomery asberg depression rating; madrs; depressive symptoms
Blood sugar
hba1c

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
11 registered symptom measure.
Not recorded
Harms were not a registered measure for this goal.
Only a number moved
1 registered test measure.

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.

Response rate (at least 50% symptom reduction) at 8 weeks versus placebo

The study showed what it set out to show

Who was studied
Cipriani network meta-analysis (522 trials pooled)
How many people
116477
Study design
Systematic review and network meta-analysis
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Odds ratios versus placebo ranged 1.37 to 2.13 with credible intervals excluding 1 for all 21 drugs
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. 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 and oral solution, once daily

Interval reported. Not recorded in this summary

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

PHQ-9 depressive symptom score 6 weeks after randomisation

The study did not show it

Who was studied
PANDA (ISRCTN84544741)
How many people
653
Study design
Pragmatic phase 4 randomised controlled trial
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
P = 0.41 (adjusted proportional difference 0.95, 95% CI 0.85 to 1.07)
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. Seven adverse events in total, four on sertraline and three on placebo; three serious, two of them on sertraline, one judged possibly related.

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

Form and route. Oral tablet and oral solution, once daily

Interval reported. 95% CI 0

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

Change from baseline in left ventricular ejection fraction at 16 weeks

The study showed what it set out to show

Who was studied
SADHART
How many people
369
Study design
Phase 4 safety and efficacy trial
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
All cardiac safety comparisons non-significant (P >= .05); CGI-I responder rate 67% vs 53%, P = .01
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 and oral solution, once daily

Interval reported. Not recorded in this summary

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

What we know
RNAWiki holds 3 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 Evidence recorded. Death, a heart attack, a stroke, a hospital stay.1 registered measure of this kind. No reviewed result.
  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.17 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.3 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 Evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in C. elegans (roundworm), Mouse, Non-human primate. A result in animals says what to test next. It does not say what happens in people.
  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: Mechanism of action presumed to be linked to inhibition of central nervous system neuronal uptake of serotonin

    US prescribing information · 00179766-980b-44b0-99d3-1fee2bb27e37 · read 2026-08-27

  1. Start

    Sertraline

    What a person takes: Oral tablet and oral solution, once daily.

    The measurement behind this step

    Immediate-release tablets and an oral concentrate. Absorption is increased by food. Steady state is reached in about a week, so both benefit and side effects are judged over weeks rather than days.

  2. Getting in

    Swallowed, absorbed, and slow to reach steady state

    The tablet is absorbed from the gut over several hours. It takes about a week of daily doses before the amount in the blood stops rising.

    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

    Oral absorption with a terminal half-life of roughly a day, so steady state is reached after about five to seven days of once-daily dosing. Extensive first-pass metabolism, principally to N-desmethylsertraline, which is far less active at the transporter.

  3. Reaching the cell

    Crosses into the brain and reaches the nerve terminals

    The molecule is greasy enough to pass out of the blood into brain tissue, where it reaches the tips of the nerve cells that release serotonin.

    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

    High lipophilicity and extensive plasma protein binding; distributes into the central nervous system and accumulates at presynaptic serotonergic terminals in cortex, hippocampus and raphe projection fields.

  4. What it acts on

    Blocks the serotonin transporter

    It plugs the pump that normally sucks serotonin back into the nerve cell after release, so the messenger stays in the gap between cells for longer.

    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

    Binds the central substrate site of SLC6A4, the sodium- and chloride-dependent serotonin transporter, preventing reuptake of 5-HT from the synaptic cleft. Occupancy is essentially complete at therapeutic doses within hours of the first dose.

  5. The change it makes

    Autoreceptors desensitise over weeks

    At first the brain compensates by turning down serotonin release. Over a few weeks that brake wears off, which is the usual explanation for why the pills take weeks to work.

    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

    Acutely, raised 5-HT at somatodendritic 5-HT1A autoreceptors in the raphe suppresses cell firing. With continued exposure those autoreceptors desensitise, firing recovers, and net forebrain serotonergic transmission rises. Downstream changes in BDNF signalling and adult hippocampal neurogenesis have been proposed but are not established in humans.

  6. What that does for a person

    Symptom scores fall, on average, by a contested amount

    Across hundreds of trials, depression and anxiety scores fall more than on a dummy pill. How much more, and for whom, is the part that is still argued about.

    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

    The measurable endpoint is a rating-scale score, not a biological marker. Response odds ratio against placebo across the network was in the range reported by Cipriani et al.; PANDA found no six-week PHQ-9 separation in unselected primary care while finding anxiety and quality-of-life separation.

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.

  • hamilton rating scale for depression range
  • clinical global impression improvement scale
  • state anxiety
  • clinical global impression severity scale
  • quality of life enjoyment and satisfaction questionnaire
  • clinical global impression improvement 2
  • liebowitz social anxiety scale
  • hamilton depression scale
  • montgomery asberg depression rating
  • madrs

and 7 more.

Measured

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

  • increase in heart rate standing
  • brachial artery flow mediated dilation
  • hba1c

Meaningful

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

  • probability of remission

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 (19)
  • days abstinent
  • cocaine use
  • adverse events
  • clinical improvement
  • panic disorder symptoms phase 1
  • panic disorder symptoms phase 2
  • panic disorder symptoms phase 3
  • ptsd symptoms
  • depression symptoms
  • ham d 17
  • clinical global impressions improvement scale
  • depressive symptoms
  • salivary cortisol levels
  • recurrence of depression
  • psychotic symptoms
  • changes in updrs subscale
  • bioequivalence
  • treatment related adverse events
  • time of retention

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 26 hours hours

    Read from the label, which states: “The average terminal elimination half-life of plasma sertraline is about 26 hours. Based on this pharmacokinetic parameter, steady-state sertraline plasma levels should be achieved after approximately one week of once-daily dosing.”

  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.

  • Adults with moderate to severe depressive episodes, and adults and children aged 6 and older with obsessive-compulsive disorder. Sertraline is one of the two SSRIs (with escitalopram) that network meta-analysis ranks highest on the joint criterion of efficacy and acceptability.

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 in patients with OCD below the age of 6 have not been established.”

    US prescribing information · 4ddfd698-3d47-fc0e-e063-6394a90accec · read 2026-08-30

  • On older people, the label states: “Of the total number of patients in clinical studies of sertraline hydrochloride in patients with MDD, OCD, PD, PTSD, SAD and PMDD, 797 (17%) were ≥ 65 years old, while 197 (4%) were ≥ 75 years old.”

    US prescribing information · 4ddfd698-3d47-fc0e-e063-6394a90accec · read 2026-08-30

  • On people who are pregnant, the label states: “Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy.”

    US prescribing information · 4ddfd698-3d47-fc0e-e063-6394a90accec · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Available data from published literature demonstrate low levels of sertraline and its metabolites in human milk [See Data] .”

    US prescribing information · 4ddfd698-3d47-fc0e-e063-6394a90accec · read 2026-08-30

  • On people with reduced liver function, the label states: “The recommended dosage in patients with mild hepatic impairment (Child-Pugh score 5 or 6) is half the recommended dosage due to increased exposure in this patient population.”

    US prescribing information · 4ddfd698-3d47-fc0e-e063-6394a90accec · read 2026-08-30

  • On people with reduced kidney function, the label states: “No dose adjustment is needed in patients with mild to severe renal impairment.”

    US prescribing information · 4ddfd698-3d47-fc0e-e063-6394a90accec · read 2026-08-30

Where the result stopped carrying

  • PANDA: primary endpoint missed at six weeks in the largest primary-care randomised trial of the drug
  • HAM-D did not separate from placebo in the full SADHART sample, only in the pre-specified severe and recurrent subgroups
  • 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 and oral solution, once daily

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

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

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

Suppression classes recorded: S6.

No source is stored against this line.

What is in the pack

Immediate-release tablets and an oral concentrate. Absorption is increased by food. Steady state is reached in about a week, so both benefit and side effects are judged over weeks rather than days.

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

The US label carries a boxed warning for increased risk of suicidal thoughts and behaviours in children, adolescents and young adults up to age 24. Common adverse effects are nausea, diarrhoea, insomnia and sexual dysfunction. Serotonin syndrome is a risk in combination with other serotonergic drugs including MAO inhibitors, which are contraindicated. Hyponatraemia occurs more often in older patients.

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.

Sertraline appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 10557 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • drug interaction — 1432 reaction mentions
  • drug hypersensitivity — 1430 reaction mentions
  • anxiety — 1081 reaction mentions
  • suicide attempt — 1012 reaction mentions
  • depression — 1004 reaction mentions
  • somnolence — 938 reaction mentions
  • serotonin syndrome — 932 reaction mentions
  • tremor — 925 reaction mentions
  • hyponatraemia — 913 reaction mentions
  • suicidal ideation — 890 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 and oral solution, once daily

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

Absorption is increased by food. Steady state is reached in about a week, so both benefit and side effects are judged over weeks rather than days.

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

  • 255 products list this as an active ingredient in the United States drug directory. 255 of them contain it and nothing else.

    FDA National Drug Code directory · 71335-3110 · read 2026-08-29

  • They are sold as capsule, powder, solution, solution, concentrate, tablet and tablet, film coated, taken oral.

    FDA National Drug Code directory · 71335-3110 · read 2026-08-29

  • The regulator's established pharmacologic class for it is cytochrome p450 2d6 inhibitors [moa], serotonin reuptake inhibitor [epc] and serotonin uptake inhibitors [moa].

    FDA National Drug Code directory · 71335-3110 · read 2026-08-29

  • 163 published labels name it as an active ingredient. 163 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · a6d0f35c-f4f4-456d-b8d9-d56297261ad6 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · a6d0f35c-f4f4-456d-b8d9-d56297261ad6 · read 2026-08-29

  • Sertraline Hydrochloride is film-coated tablets at 25 mg, 50 mg and 100 mg of sertraline, recorded as prescription product; fda label in effect 2019-11-01 in the United States.

    US prescribing information · 00179766-980b-44b0-99d3-1fee2bb27e37 · read 2026-08-27

  • Recorded price in US: 0.02818–1.9883 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 136 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

  • Recorded price in US: 0.39651 USD per one millilitre, across 4 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.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Sertraline 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 depression involves a serotonin deficiency that sertraline corrects — the umbrella review found no consistent biomarker evidence, and the efficacy trials never measured serotonin

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 STAR*D's 67% cumulative remission rate is an antidepressant effect, when the study had no placebo comparator

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 the average trial effect, drawn from populations selected for at least moderate severity, transfers unchanged to mild depression

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 Sertraline 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.

All 21 antidepressants beat placebo across 522 trials and 116,477 participants
In plain words
The biggest analysis ever done found that every antidepressant tested worked better than a dummy pill, with sertraline in the group that combined good results with people staying on it.
What was measured
Odds ratio for treatment response versus placebo, network meta-analysis
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Cipriani et al. searched to January 2016 and included 522 double-blind randomised trials of 21 antidepressants in adults with major depressive disorder, 116,477 participants. All 21 were more efficacious than placebo on response rate, with odds ratios from 2.13 (95% CrI 1.89 to 2.41) for amitriptyline down to 1.37 (1.16 to 1.63) for reboxetine. The paper explicitly rated certainty of evidence with GRADE and found it moderate to very low for most comparisons.
Source
Cipriani A et al., Lancet 2018;391:1357-1366
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
PANDA: sertraline missed its primary endpoint at six weeks in 653 primary-care patients
In plain words
In the biggest trial of sertraline in ordinary general practice, depression scores at six weeks were no better than on placebo. Anxiety and self-rated mental health did improve.
What was measured
PHQ-9 depressive symptom score at 6 weeks
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Pragmatic, double-blind, placebo-controlled trial across 179 UK primary care surgeries; 655 randomised, 653 analysed, 550 with primary outcome data. Mean 6-week PHQ-9 was 7.98 (SD 5.63) on sertraline and 8.76 (5.86) on placebo — adjusted proportional difference 0.95, 95% CI 0.85 to 1.07, p=0.41. Secondary outcomes favoured sertraline for anxiety symptoms, mental health-related quality of life and self-rated improvement, and the authors reported weak evidence of a depressive-symptom effect by 12 weeks. The trial did not select on diagnostic threshold, which is exactly why it generalises to how the drug is actually prescribed.
Source
Lewis G et al., Lancet Psychiatry 2019;6:903-914 (ISRCTN84544741)
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 serotonin-deficiency explanation lost its evidence base, and the drug did not
In plain words
A 2022 review of every relevant research area found no consistent evidence that depression involves low serotonin. That is a claim about the explanation, not about whether the pills work — and both halves have to be held at once.
What was measured
That SSRIs work by correcting a serotonin deficiency — an explanation the biomarker literature does not support, and which was never what the efficacy trials measured
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Moncrieff et al. ran an umbrella review of 17 studies covering 5-HIAA and serotonin concentrations, 5-HT1A receptor binding, SERT imaging and post-mortem levels, tryptophan depletion, and SERT gene and gene-environment studies. Two meta-analyses of 5-HIAA showed no association with depression (largest n=1002); one meta-analysis of plasma serotonin found no relationship and found lowered serotonin associated with antidepressant use (n=1869). Jauhar et al., writing for 35 co-authors, replied that the conclusion was overstated on grounds of selective reporting and misreading of the tryptophan-depletion and molecular-imaging literatures. Neither paper is a trial of sertraline, and neither changes the Cipriani estimate.
Source
Moncrieff J et al., Mol Psychiatry 2023;28:3243-3256; reply Jauhar S et al., Mol Psychiatry 2023;28:3149-3152
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
Effect size versus placebo depends on baseline severity, and is small below the top of the range
In plain words
Analysing the trial data the FDA holds rather than only what was published, the gap between drug and placebo grows as depression gets more severe, and is small for anyone who is not very severely ill.
What was measured
That the average benefit found in trials of moderately depressed populations transfers to mild depression, where the drug-placebo gap in the FDA dataset is smallest
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Kirsch et al. obtained all clinical trials submitted to the FDA for four new-generation antidepressants including published and unpublished data, and modelled improvement against baseline severity. Drug-placebo differences increased with initial severity, reaching conventional criteria for clinical significance only at the upper end of the very severe category. The mechanism they identified was decreasing placebo responsiveness in severe depression, not increasing drug responsiveness. The finding is about the average patient in the regulatory dataset; it says nothing about any individual.
Source
Kirsch I et al., PLoS Med 2008;5:e45
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
SADHART: safe after myocardial infarction, and the primary endpoint was safety, not mood
In plain words
In 369 patients who had just had a heart attack or unstable angina, sertraline did not damage heart function. Its effect on depression was clearest in the most severe and most recurrent cases.
What was measured
Change in left ventricular ejection fraction; CGI-I responder rate
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Randomised, double-blind, placebo-controlled, 40 centres, 369 patients with major depression after acute MI (74%) or unstable angina (26%), 24 weeks. The primary outcome was safety: no significant effect on left ventricular ejection fraction, ventricular premature complex runs, or QTc above 450 ms. Severe cardiovascular adverse events occurred in 14.5% on sertraline and 22.4% on placebo. CGI-I responder rates were 67% versus 53% overall (p=0.01), 72% versus 51% in those with a prior episode (p=0.003), and 78% versus 45% in the pre-specified severe subgroup (p=0.001). HAM-D did not separate in the total sample (p=0.14).
Source
Glassman AH et al., JAMA 2002;288:701-709
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
Discontinuation symptoms occur in about a third of people, and in a sixth after placebo
In plain words
Stopping an antidepressant produced at least one withdrawal symptom in roughly 31 people in 100. Stopping a placebo produced one in 17 people in 100, so the drug-caused share is smaller than the headline number.
What was measured
Incidence of at least one discontinuation symptom after stopping
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Henssler et al. pooled 79 studies (44 randomised trials, 35 observational) covering 21,002 patients; 16,532 discontinued an antidepressant and 4,470 discontinued placebo. Incidence of at least one discontinuation symptom was 0.31 (95% CI 0.27 to 0.35) after antidepressants and 0.17 (0.14 to 0.21) after placebo. Within randomised trials the summary difference in incidence was 0.08 (0.04 to 0.12). Severe symptoms occurred in 0.028 (0.014 to 0.057) after antidepressants against 0.006 (0.002 to 0.013) after placebo. Desvenlafaxine, venlafaxine and imipramine ranked highest for incidence.
Source
Henssler J et al., Lancet Psychiatry 2024;11:526-535
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
STAR*D: cumulative remission after four steps was 67%, and the number is not a drug effect
In plain words
The largest real-world treatment study reported that two thirds of patients eventually remitted after up to four medication steps. There was no placebo group, so the figure cannot be attributed to the drugs.
What was measured
That the 67% cumulative remission rate is a measure of what antidepressants achieve, when the design has no comparator to measure it against
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
STAR*D was an open, sequenced, non-randomised-to-placebo effectiveness study. QIDS-SR-16 remission rates were 36.8%, 30.6%, 13.7% and 13.0% at steps one to four, with an overall cumulative remission rate of 67%. Relapse during naturalistic follow-up rose with the number of steps required. The cumulative figure is routinely quoted as evidence of antidepressant efficacy; without a concurrent control arm it describes what happened to a cohort over a year, and cannot separate drug effect from natural course, regression to the mean and repeated measurement.
Source
Rush AJ et al., Am J Psychiatry 2006;163:1905-1917
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

How many documents were read

  • 163 documents were read for this substance.

    RNAWiki source record

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

    RNAWiki source record

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

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
UTI8907Y6X
CAS registry number
79617-96-2
PubChem compound
68617
RxNorm concept
155137

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

  • Passed

    Safety mode resolved

    Suppression classes recorded: S6.

  • 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

  • 39 approved applications cover products containing this substance. The earliest was NDA019839, approved 19911230 to VIATRIS.

    Drugs@FDA application register · NDA019839 · read 2026-08-29

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

    Drugs@FDA application register · NDA019839 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19911230.

    FDA National Drug Code directory · 71335-3110 · 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 serotonin reuptake blocker that beat placebo across 522 randomised trials in the largest antidepressant network meta-analysis ever run, and then missed its primary endpoint at six weeks in the largest primary-care trial ever run on it.

Recorded evidence blocks (15)

What did Sertraline's largest trial (3255526 people) and its longest (33 years) measure?


3255526 people in Sertraline's largest registered study, 33 years in its longest registered window, measuring A composite outcome of all-cause hospitalization, all-cause emergency department visit, or all-cause mortality. ClinicalTrials.gov · 2026-09-01

79 phase4, 55 phase2, 55 phase3, 41 na, 30 phase1, 21 na or unstated, 1 early phase1; NCT00262470; 2029-12. Last human test completed 2026, NCT07387120.

Interpretation These counts include studies where Sertraline 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
  • phase4
    79
  • phase2
    55
  • phase3
    55
  • na
    41
  • phase1
    30
  • na or unstated
    21
2 more recorded rows
  • early phase1
    1
  • Last recorded human test NCT07387120
    2026-01

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

From C. elegans to human: where has Sertraline shown lifespan?


C. elegans: lifespan, NHP: mechanism-only, mouse: lifespan and human: lifespan (265): the rungs where Sertraline has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation A composite outcome of all-cause hospitalization, all-cause emergency department visit, or all-cause mortality. — the recorded outcome words.

Yeast C. elegans lifespanDrosophila Mouse lifespanRat Dog Non-human primate mechanism-onlyHuman lifespan
Show the evidence
  • C. elegans
    lifespan
  • NHP
    mechanism-only
  • mouse
    lifespan
  • human NCT07387120
    lifespan; A composite outcome of all-cause hospitalization, all-cause emergency department visit, or all-cause mortality.; 265

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

35 of Sertraline's trials stopped: safety, accrual/recruitment, funding/business, other?


safety (1), accrual/recruitment (17), funding/business (5) and other (12): Sertraline's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"See Detailed Description for termination reason."; 35 of 265 registered studies

Show the evidence

Trial

  • NCT00143091
    terminated; "See Detailed Description for termination reason."
  • NCT00150306
    terminated; "Please see Detailed Description below for termination reason."
  • NCT00177424
    terminated; "Recruitment goals could not be met."
  • NCT00182533
    terminated; "Study drug could not be re-supplied"
  • NCT00208117
    terminated; "Unable to enroll subjects"
  • NCT00232167
    terminated; "Please see Detailed Description below for termination reason."
14 further recorded trials
  • NCT00249431
    terminated; "Inability to recruit patients."
  • NCT00299611
    terminated; "Sponsor decided to terminate the study due to budget consideration"
  • NCT00391430
    terminated; "Difficulty enrolling subjects"
  • NCT00585455
    terminated; "PI change in institution"
  • NCT00744328
    terminated; "Recruitment Issues"
  • NCT00955474
    terminated; "AstraZeneca halted funding; patent expired for Seroquel (Quetiapine) in 2012"
  • NCT01309074
    withdrawn; "No subjects could be enrolled and therefore we decided to withdraw/stop the study."
  • NCT01703039
    terminated; "PI departure, slow recruitment"
  • NCT01751828
    withdrawn; "This was an initial unfunded pilot project stopped after similar studies were funded."
  • NCT01769027
    withdrawn; "No participants enrolled"
  • NCT01794455
    terminated; "Enrollment difficulties"
  • NCT01856127
    terminated; "PI left institution"
  • NCT01977729
    terminated; "funding"
  • NCT02185547
    terminated; "Difficulties in recruiting participants."

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

Human studies of Sertraline used Zoloft 50 mg — over how long?


studies of Sertraline used the recorded amount. ClinicalTrials.gov · 2026-09-01

14 recorded entries; human; also "Zoloft 50 mg", "Sertraline Hydrochloride Tablets 100 mg", "Zoloft® Tablets 100 mg"

Show the evidence

human

  • NCT00066859
    Zoloft 50 mg
  • NCT00648856
    Sertraline Hydrochloride Tablets 100 mg
  • NCT00648856
    Zoloft® Tablets 100 mg
  • NCT00778973
    sertraline 100 mg tablets
  • NCT00836667
    Zoloft® 100 mg Tablets
  • NCT00836667
    Sertraline hydrochloride 100 mg Tablets
8 more recorded rows
  • human NCT00864019
    Sertraline HCl 100 mg tablets, single dose
  • human NCT00864019
    Zoloft® 100 mg tablets, single dose
  • human NCT03068429
    sertraline 50mg
  • human NCT04071639
    Zoloft 50Mg Tablet
  • human NCT06025474
    Sertraline 50 MG
  • human NCT06778824
    ZOLOFT Film Coated Tablets 50 mg
  • human NCT07387120
    Sertraline 50 mg
  • human NCT07387120
    Sertraline 25 mg

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

More Sertraline was worse in human: at what point?


U-shaped in human: "In a cohort of 593 patients who underwent high-sensitivity C-reactive protein (hsCRP) testing, a nonlinear, U-shaped correlation between hsCRP levels and sertraline concentrations was identified in children and adolescents." Europe PMC · dose-response search · 2026-03-25

5 recorded sentences naming Sertraline; U-shaped, dose-response, Dose-response

Show the evidence
  • U-shaped PMID 40481507
    "In a cohort of 593 patients who underwent high-sensitivity C-reactive protein (hsCRP) testing, a nonlinear, U-shaped correlation between hsCRP levels and sertraline concentrations was identified in children and adolescents."
  • dose-response PMID 41930641
    "Among liver enzymes, ALP demonstrated the most pronounced dose-response, whereas bilirubin showed the weakest association with sertraline dosage."
  • Dose-response PMID 41741691
    "Dose-response experiments using the tricyclic antidepressant, amitriptyline (0.3-3.0 mg/kg), monoamine oxidase inhibitor, moclobemide (3.0-10.0 mg/kg) and serotonin specific re-uptake inhibitor, sertraline (1.0-10.0 mg/kg) were performed."

dose-response

  • PMID 41229644
    "Sertraline can rarely cause urinary incontinence, with symptoms showing a dose-response relationship that improves after dose reduction.Recognition and management of this adverse effect (through dose adjustment, switching or adjunctive therapy) allows clinicians to maintain psychiatric remission while minimising distressing urinary symptoms."
  • PMID 40062740
    "Subsequently, the cumulative dose of sertraline, citalopram, and escitalopram was calculated, and Cox proportional hazards regression was used to assess dose-response-like relationships with osteoporosis."

recorded 2026-03-25 · last checked 2026-09-04

Sertraline's half-life is about 26 hours — which schedules were studied?


about 26 hours, the half-life Sertraline's label states. openfda-label · 957ba196-0b9b-4cda-bd15-28357ced8d2f · 2026-08-27

Show the evidence
  • half life
    about 26 hours hours; The average terminal elimination half-life of plasma sertraline is about 26 hours. Based on this pharmacokinetic parameter, steady-state sertraline plasma levels should be achieved after approximately one week of once-daily dosing.
  • tmax
    There was a 23% increase in T max for desmethyldiazepam in the sertraline hydrochloride group compared to a 20% decrease in the placebo group (p<0.03) [ See Drug Interactions ( 7.2 ) ].
  • bioavailability
    Linear dose-proportional pharmacokinetics were demonstrated in a single dose study in which the C max and area under the plasma concentration time curve (AUC) of sertraline were proportional to dose over a range of 50 to 200 mg. The single dose bioavailability of sertraline hydrochloride tablets is approximately equal to an equivalent dose of sertraline hydrochloride oral solution.
  • metabolism
    Metabolism Sertraline undergoes extensive first pass metabolism.

recorded 2026-08-27 · last checked 2026-09-04

Which of 21 item hamilton depression rating scale, adverse events and beck depression inventory ii scores over 16 weeks did Sertraline's trials measure?


21 item hamilton depression rating scale, adverse events and beck depression inventory ii scores over 16 weeks lead 40 outcome terms across Sertraline's trials. ClinicalTrials.gov · 2026-09-01

adverse events, clinical improvement, clinical global impression improvement scale, panic disorder symptoms phase 1, panic disorder symptoms phase 2 and panic disorder symptoms phase 3 follow.

Show the evidence
  • hamilton rating scale for depression range
    1
  • days abstinent
    1
  • cocaine use
    1
  • adverse events
    1
  • clinical improvement
    1
  • clinical global impression improvement scale
    1
14 more recorded rows
  • panic disorder symptoms phase 1
    1
  • panic disorder symptoms phase 2
    1
  • panic disorder symptoms phase 3
    1
  • ptsd symptoms
    1
  • depression symptoms
    1
  • state anxiety
    1
  • ham d 17
    1
  • clinical global impressions improvement scale
    1
  • clinical global impression severity scale
    1
  • quality of life enjoyment and satisfaction questionnaire
    1
  • clinical global impression improvement 2
    1
  • liebowitz social anxiety scale
    1
  • hamilton depression scale
    1
  • montgomery asberg depression rating
    1

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

Which of Sertraline's 22 ongoing trials reports first?


22 registered trials of Sertraline are open; earliest completion 2025-04-15. ClinicalTrials.gov · 2026-09-01

Increase in heart rate with standing; M/P ratio; latest 2029-12

Show the evidence

Trial

  • NCT00262470
    "Treatment of Orthostatic Intolerance"; n 150; "Increase in heart rate with standing"; 2029-12
  • NCT03511118
    "Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants"; n 1600; "M/P ratio"; 2028-07-31
  • NCT04221997
    "Trial With the Treatment of Sertraline in Youth With Generalized, Separation and/or Social Anxiety Disorders."; n 150; "Number of Participants with Clinical Global Impression-Improvement Scale ≤ 2"; 2026-09
  • NCT04278404
    "Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)"; n 5000; "Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling"; 2026-12
  • NCT04637620
    "NMDA Modulation in Major Depressive Disorder"; n 90; "Change in Hamilton Rating Scale for Depression"; 2026-12
  • NCT05273996
    "Predictors of Cognitive Outcomes in Geriatric Depression"; n 75; "Montgomery-Asberg Depression Rating Scale (MADRAS)"; 2027-04-30
14 further recorded trials
  • NCT05603104
    "Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure"; n 1254; "Change in symptom severity"; 2028-06-30
  • NCT05683223
    "Neural Markers of Treatment Mechanisms and Prediction of Treatment Outcomes in Social Anxiety"; n 240; "Change in Clinical Global Impression-Improvement Scale (CGI-I)"; 2027-06-30
  • NCT05814640
    "Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)"; n 520; "Change in CDRS-R (Children's Depression Rating Scale) scores from baseline"; 2027-07-01
  • NCT05892744
    "Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression"; n 50; "Change from Baseline on the GRID Hamilton Depression Rating Scale (GRID-HAM-D) at 8 weeks"; 2027-07-15
  • NCT05973786
    "The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment."; n 418; "Comparing the change in symptom severity on Montgomery Asberg Depression Rating Scale"; 2028-06-30
  • NCT06081348
    "Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders"; n 130; "The Screen for Child Anxiety Related Emotional Disorders (SCARED) - parent version"; 2027-09
  • NCT06337539
    "Precision Psychiatry for Depression: Immune Response and Affective Symptoms as Predictors of Response to Antidepressants"; n 50; "Treatment Response"; 2027-07-31
  • NCT06384209
    "The Friendship Bench Plus Trial"; n 296; "Treatment response"; 2028-02-28
  • NCT06408246
    "ACE-D Aim 3 Clinical Cognitive Trial to Enhance Translation in Depression"; n 162; "Remission of depressive symptoms"; 2029-02-01
  • NCT06778824
    "Neuroregulators for the Treatment of Diseases Associated With Esophageal-brain-gut Axis Communication Abnormalities."; n 610; "Gastroesophageal Reflux Disease Questionnaire(GERDQ)"; 2025-12-31
  • NCT06827431
    "The Research of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression"; n 770; "Change from baseline in Montgomery Asperger Depression Scale (MADRS) score at the end of treatment (week 8)"; 2026-09-30
  • NCT06840379
    "Effect of Sertraline on Inflammation in Hemodialysis Patients with Depression: a Randomized Controlled Trial"; n 62; "Mean Change in Serum C-Reactive Protein (CRP) Levels from Baseline to 12 Weeks"; 2025-04-15
  • NCT07011693
    "Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression(SMART-I)"; n 400; "response rate of Children's Depression Rating Scale (CDRS-R) scores"; 2027-12
  • NCT07192367
    "Comparison of the Effectiveness Level of Virtual Reality Exposure Therapy With Sertraline Treatment in Social Anxiety Disorder"; n 56; "Change in Social Anxiety Symptoms (Liebowitz Social Anxiety Scale, LSAS)"; 2026-12

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

Which running trial of Sertraline could settle inflammatory markers?


NCT06840379 measures Mean Change in Serum C-Reactive Protein (CRP) Levels from Baseline to 12 Weeks, reading out 2025-04-15.

1 open trial; n 62; "Effect of Sertraline on Inflammation in Hemodialysis Patients with Depression: a Randomized Controlled Trial"

Show the evidence
  • Trial NCT06840379
    "Effect of Sertraline on Inflammation in Hemodialysis Patients with Depression: a Randomized Controlled Trial"; n 62; "Mean Change in Serum C-Reactive Protein (CRP) Levels from Baseline to 12 Weeks"; 2025-04-15

Which 104 trials of Sertraline posted no result?


Posted no result
104 of 104 completed trials
Registrations
NCT00001777, NCT00015132, NCT00000446, NCT00005013, NCT00000458 and NCT00000384, and 98 more
Completion dates
oldest 2000-05; newest 2024-03-20
Show the evidence

Trial

  • NCT00001777
    2000-05
  • NCT00015132
    2000-11
  • NCT00000446
    2000-12
  • NCT00005013
    2001-07
  • NCT00000458
    2002-01
  • NCT00000384
    2002-04
14 further recorded trials
  • NCT00836667
    2002-04
  • NCT00836849
    2002-04
  • NCT00001483
    2002-05
  • NCT00000440
    2002-09
  • NCT00650325
    2002-12
  • NCT01114100
    2002-12
  • NCT00648856
    2003-01
  • NCT00179283
    2003-04
  • NCT00208702
    2003-07
  • NCT00601588
    2003-07
  • NCT00602849
    2003-07
  • NCT00644982
    2003-09
  • NCT00050804
    2004-02
  • NCT00118014
    2004-08

At the median, Sertraline's trials enrolled 93 people — anything larger?


Median enrolment
93
Largest enrolment
3255526
Registered trials counted
259

What do 10557 spontaneous reports say about Sertraline — 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.

Sertraline appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 10557 reaction mentions were counted: drug interaction 1432; drug hypersensitivity 1430; anxiety 1081; suicide attempt 1012. open-targets-adr · CHEMBL1709 · 2026-06-24

Show the evidence
  • drug interaction
    1432
  • drug hypersensitivity
    1430
  • anxiety
    1081
  • suicide attempt
    1012
  • depression
    1004
  • somnolence
    938
4 more recorded rows
  • serotonin syndrome
    932
  • tremor
    925
  • hyponatraemia
    913
  • suicidal ideation
    890

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

Sertraline and CYP2D6 and CYP3A4: shared by which compounds?


CYP2D6 and CYP3A4 appear in Sertraline's recorded interaction sentences, 5 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics

Show the evidence

CYP2D6

  • pharmacokinetics
    The drugs for which this potential interaction is of greatest concern are those metabolized primarily by CYP2D6 and that have a narrow therapeutic index (e.g., tricyclic antidepressant drugs and the Type 1C antiarrhythmics propafenone and flecainide).
  • pharmacokinetics
    Drugs Metabolized by CYP2D6 Many antidepressant drugs (e.g., SSRIs, including sertraline hydrochloride, and most tricyclic antidepressant drugs) inhibit the biochemical activity of the drug metabolizing isozyme CYP2D6 (debrisoquin hydroxylase), and, thus, may increase the plasma concentrations of co-administered drugs that are metabolized by CYP2D6.
  • pharmacokinetics
    The extent to which this interaction is an important clinical problem depends on the extent of the inhibition of CYP2D6 by the antidepressant and the therapeutic index of the co-administered drug.

CYP3A4

  • pharmacokinetics
    These data indicate that sertraline hydrochloride’s extent of inhibition of CYP3A4 activity is not likely to be of clinical significance.
  • pharmacokinetics
    Drugs Metabolized by CYP3A4 In three separate in vivo interaction studies, sertraline hydrochloride was co-administered with CYP3A4 substrates, terfenadine, carbamazepine, or cisapride under steady-state conditions.

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

Was Sertraline studied with exercise?


exercise is named in Sertraline's label sentences: "In this secondary analysis of the SMILE-II trial, 148 sedentary adults with MDD were randomized to: (a) supervised exercise, (b) home-based exercise, (c) sertraline, or (d) placebo control." openfda-label+europepmc · 2026-08-30

1 recorded statement; exercise

Show the evidence
  • exercise
    In this secondary analysis of the SMILE-II trial, 148 sedentary adults with MDD were randomized to: (a) supervised exercise, (b) home-based exercise, (c) sertraline, or (d) placebo control.

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

What is recorded about Sertraline and mTOR?


"Among 3,200 compounds consisting of FDA-approved drugs or are under active development, 547 compounds targeting neurological diseases were filtered in, and three compounds (sertraline, tiagabine and bicifadine) were finally identified to exhibit the autophagy-inducing activity and also demonstrated the autophagy-dependent neuroprotective…" — where Sertraline and mTOR appear together. Europe PMC · pathway abstract search · 2025-04-25

mTOR, autophagy, AMPK, IGF-1; PMID 40278973, 40187044, 39392873, 38228128

Show the evidence
  • mTOR PMID 40278973
    "Among 3,200 compounds consisting of FDA-approved drugs or are under active development, 547 compounds targeting neurological diseases were filtered in, and three compounds (sertraline, tiagabine and bicifadine) were finally identified to exhibit the autophagy-inducing activity and also demonstrated the autophagy-dependent neuroprotective action by inhibiting the mammalian target of rapamycin…"
  • autophagy PMID 40278973
    "Among 3,200 compounds consisting of FDA-approved drugs or are under active development, 547 compounds targeting neurological diseases were filtered in, and three compounds (sertraline, tiagabine and bicifadine) were finally identified to exhibit the autophagy-inducing activity and also demonstrated the autophagy-dependent neuroprotective action by inhibiting the mammalian target of rapamycin…"
  • mTOR PMID 40278973
    "In conclusion, compounds like sertraline, tiagabine, and bicifadine that have the ability to induce autophagy and inhibit mTOR might be repurposed as PD treatment to protect the neuronal cells."
  • autophagy PMID 40278973
    "In conclusion, compounds like sertraline, tiagabine, and bicifadine that have the ability to induce autophagy and inhibit mTOR might be repurposed as PD treatment to protect the neuronal cells."
  • mTOR PMID 40187044
    "Moreover, we underscore the activation of autophagy as a potential therapeutic strategy across different NDs and small molecules capable of activating autophagy pathways, such as rapamycin targeting the mTOR pathway to clear α-synuclein and Sertraline targeting the AMPK/mTOR/RPS6KB1 pathway to clear Tau, to further illustrate their potential in NDs' therapeutic intervention."
  • AMPK PMID 40187044
    "Moreover, we underscore the activation of autophagy as a potential therapeutic strategy across different NDs and small molecules capable of activating autophagy pathways, such as rapamycin targeting the mTOR pathway to clear α-synuclein and Sertraline targeting the AMPK/mTOR/RPS6KB1 pathway to clear Tau, to further illustrate their potential in NDs' therapeutic intervention."
2 more recorded rows
  • autophagy PMID 40187044
    "Moreover, we underscore the activation of autophagy as a potential therapeutic strategy across different NDs and small molecules capable of activating autophagy pathways, such as rapamycin targeting the mTOR pathway to clear α-synuclein and Sertraline targeting the AMPK/mTOR/RPS6KB1 pathway to clear Tau, to further illustrate their potential in NDs' therapeutic intervention."
  • IGF-1 PMID 39392873
    "Fluoxetine and sertraline reduce height gain and IGF-1 concentration, in a dose-dependent manner."

AMPK

  • PMID 38228128
    "Mechanistically, ser-7 orchestrated sertraline-induced longevity via the regulation of insulin and AMPK pathways, and sertraline-induced lifespan extension in nematodes was abolished in ser-7 RNAi strain, daf-2, daf-16, and aak-2 mutants."
  • PMID 38228128
    "Sertraline promotes health and longevity in C. elegans through ser-7-insulin/AMPK pathways."

recorded 2025-04-25 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1709
PubChem CID
63009
CAS number
79559-97-0
RxCUI
155137
InChIKey
VGKDLMBJGBXTGI-SJCJKPOMSA-N
Also called
SERTRALINE HYDROCHLORIDE, ssri, Sertralina, selective serotonin reuptake inhibitors, sert, sertralin, ssri sertraline, ssris, SERTRALINE [HSDB], SERTRALINE [MI], SERTRALINE [VANDF], Sertraline [WHO-DD]
Trade name
Aremis, Besitron, Lustral, Zoloft
Development code
CP-51,974-1, CP-51974-1, NSC-746308, NSC-758948
Salt form
Sertraline hcl, sertraline hcl 100 mg tablets, zoloft 100 mg tablets, zoloft tablets
Sources (11)

Sources

  • ClinicalTrials.gov clinicaltrials.gov ·
  • ClinicalTrials.gov ClinicalTrials.gov API v2 snapshot 2026-09-01T09:00:05 ·
  • this record's own fields 2,3,5 ·
  • Europe PMC dose-response search ·
  • Europe PMC pathway abstract search ·
  • Europe PMC search ·
5 more sources

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: 11 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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