This page shows what was measured, who it was measured in, and what that does not settle.
What Zolpidem does in the body
Insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep
From the FDA-approved label: Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties. It interacts with a GABA-BZ receptor complex and shares some of the pharmacological properties of the benzodiazepines. In contrast to the benzodiazepines, which non-selectively bind to and activate all BZ receptor subtypes, zolpidem in vitro binds the BZ 1 receptor preferentially with a high affinity ratio of the α 1 /α 5 subunits.
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
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
The substance registry classes this as chemical.
FDA substance registry · 7K383OQI23 · read 2026-08-29
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 108 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.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
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 people◇Read 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.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Sleep
…Waiting for a reviewer1 registered study measure of this kind. No reviewed result yet.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
…Waiting for a reviewer5 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.
Focus
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Energy
∅Nothing 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.
Pain
∅Nothing 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
sleep latency; pittsburgh sleep quality index; diary sleep efficiency; latency to persistent sleep measured by polysomnography; assessment of insomnia severity index; assessment of pittsburgh sleep quality index; latency to persistent sleep; sleep efficiency
Focus
memory; lapses of attention
Energy
assessment of fatigue
Pain
brief pain 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
… Waiting for a reviewer
1 registered study measure of this kind. No reviewed result yet.
∅ Nothing in the sources checked
No registered study lists a performance measure for this goal.
— Not recorded
Harms were not a registered measure for this goal.
What happened in people◇Read 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.
Relative treatment response rates during acute (1-month) treatment phase
✗ The study did not show it
Who was studied
NCT07542756
How many people
1200
Study design
Phase 4
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
The primary efficacy variable is item 1 (which assessed sleep aid) of the Patient Global Impression (PGI) scale at week 12.
✗ The study did not show it
Who was studied
NCT00425243
How many people
1025
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 in Mean Latency to Persistent Sleep (LPS) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30
✗ The study did not show it
Who was studied
NCT02783729
How many people
1006
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 wake time after sleep onset during the double-blind period
✗ The study did not show it
Who was studied
NCT00283946
How many people
876
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 Day 1&2 in Wake After Sleep Onset (WASO)
✗ The study did not show it
Who was studied
NCT00608985
How many people
709
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
Double-blind Period: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 8
✗ The study did not show it
Who was studied
NCT05693935
How many people
675
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 people◇Read 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.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.1 registered measure of this kind. No reviewed result.
■What a body can do day to dayEvidence recorded. Walking, dressing, breathing, recovering.1 registered measure of this kind.
■Measured performanceEvidence recorded. How much was lifted, how far was run, how fast.1 registered measure of this kind.
■Symptoms and quality of lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.8 registered measures of this kind.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.2 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, Rat. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo 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 take◇Read 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.
pittsburgh sleep quality index
assessment of clinical global impression change
assessment of insomnia severity index
assessment of pittsburgh sleep quality index
assessment of fatigue
brief pain inventory
total of pittsburgh sleep quality index
sleep quality
Measured
Things only a test, a scale or a device shows.
cmax maximum observed concentration
maximum plasma concentration
Meaningful
Things that change how a life goes, not only a number.
who met remission as measured by the insomnia severity index
changes in motor function
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 (28)
primary efficacy variable was the mean apnea hypopnea index
sleep latency
diary sleep efficiency
choice reaction time
digit symbol substitution test
latency to persistent sleep measured by polysomnography
assessment of sleepiness
polysomnography data
sensory organization test composite
bioequivalence
latency to persistent sleep
sleep efficiency
marijuana withdrawal
eeg power density in slow wave frequencies during nrem sleep
memory
blood oxygen level dependent signal as measured fmri
objective total sleep time
objective sleep onset latency
self reported total sleep time
self reported sleep onset latency
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 take◇Read 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.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
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.
How fast the body clears it. 9.9 hr hours
Read from the label, which states: “The mean half-life in cirrhotic patients of 9.9 hr (range: 4.1 to 25.8 hr) was greater than that observed in normal subjects of 2.2 hr (range: 1.6 to 2.4 hr) [see Dosage and Administration (2.2) , Warnings and Precautions (5.8) , Use in Specific Populations (8.7) ] .”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
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 unclear◇Read 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.
Zolpidem tartrate sublingual tablets are indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Limitations of Us e: Zolpidem tartrate sublingual tablets are not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking.
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 of zolpidem in pediatric patients below the age of 18 years have not been established.”
US prescribing information · 747949c5-2c91-4909-8a07-71b6826f8e97 · read 2026-08-30
On older people, the label states: “A total of 154 patients in U.S. controlled clinical trials and 897 patients in non-U.S. clinical trials who received zolpidem were ≥60 years of age.”
US prescribing information · 747949c5-2c91-4909-8a07-71b6826f8e97 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation [see Clinical Considerations and Data ] .”
US prescribing information · 747949c5-2c91-4909-8a07-71b6826f8e97 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Limited data from published literature report the presence of zolpidem in human milk.”
US prescribing information · 747949c5-2c91-4909-8a07-71b6826f8e97 · read 2026-08-30
On people with reduced liver function, the label states: “The recommended dose of AMBIEN in patients with mild to moderate hepatic impairment is 5 mg once daily immediately before bedtime.”
US prescribing information · 747949c5-2c91-4909-8a07-71b6826f8e97 · 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 take◇Read 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 take◇Read 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
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
Sold as tablet, tablet, extended release, spray, metered, capsule, given by the oral, sublingual 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 take∅Nothing 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.
Zolpidem appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 7468 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
drug abuse — 1142 reaction mentions
fall — 884 reaction mentions
somnolence — 862 reaction mentions
confusional state — 806 reaction mentions
suicide attempt — 722 reaction mentions
amnesia — 683 reaction mentions
drug dependence — 664 reaction mentions
toxicity to various agents — 632 reaction mentions
coma — 592 reaction mentions
insomnia — 481 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 unclear◇Read 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
159 products list this as an active ingredient in the United States drug directory. 159 of them contain it and nothing else.
FDA National Drug Code directory · 71610-913 · read 2026-08-29
They are sold as capsule, powder, tablet, tablet, coated, tablet, extended release and tablet, film coated, taken oral and sublingual.
FDA National Drug Code directory · 71610-913 · read 2026-08-29
The regulator's established pharmacologic class for it is central nervous system depression [pe], gaba a agonists [moa] and gaba a receptor positive modulators [moa].
FDA National Drug Code directory · 71610-913 · read 2026-08-29
117 published labels name it as an active ingredient. 117 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 7abb6898-223c-487b-856c-068ac04f7a5c · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 7abb6898-223c-487b-856c-068ac04f7a5c · read 2026-08-29
Ambien is oral at 3 DOSAGE FORMS AND STRENGTHS AMBIEN is available in 5 mg and 10 mg strength tablets for oral administration., recorded as fda label in effect 2025-02-07 in the United States.
US prescribing information · 747949c5-2c91-4909-8a07-71b6826f8e97 · read 2026-08-30
Recorded price in US: 0.03469–7.93327 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 28 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 take◇Read 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 Zolpidem 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 unclear◇Read 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 Zolpidem 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 people◇Read 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
117 documents were read for this substance.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
7K383OQI23
CAS registry number
82626-48-0
PubChem compound
5732
ChEMBL
CHEMBL911
ChEBI
10125
WHO international nonproprietary name list entry
5741
RxNorm concept
39993
EMA substance identifier
100000078817
DrugBank
DB00425
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Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
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Suppression classes recorded: S6.
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What is missing or unclear◇Read 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
43 approved applications cover products containing this substance. The earliest was NDA019908, approved 19921216 to COSETTE.
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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.
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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 (13)
Q2
What did Zolpidem's largest trial (5000 people) and its longest (8.9 years) measure?
5000 people in Zolpidem's largest registered study, 8.9 years in its longest registered window, measuring Changes in motor function. ClinicalTrials.gov · 2026-09-01
36 phase4, 24 phase1, 21 phase3, 18 na, 17 phase2, 5 early phase1, 4 na or unstated; NCT05746143; 2030-12-31. Last human test completed 2025, NCT06975514.
Interpretation These counts include studies where Zolpidem 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
36
phase1
24
phase3
21
na
18
phase2
17
early phase1
5
2 more recorded rows
na or unstated
4
Last recorded human testNCT06975514
2025-08-14
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Zolpidem shown lifespan?
Interpretation Changes in motor function — the recorded outcome words.
Show the evidence
mouse
mechanism-only
rat
lifespan
humanNCT03621046
healthspan; Changes in motor function; 120
recorded 2026-09-01 · last checked 2026-09-04
Q4
7 of Zolpidem's trials stopped: accrual/recruitment, funding/business, other?
accrual/recruitment (3), funding/business (1) and other (3): Zolpidem's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"Slow inclusion resulting in premature termination due to logistics"; 7 of 120 registered studies
Show the evidence
Trial
NCT00286936
terminated; "Slow inclusion resulting in premature termination due to logistics"
NCT00781482
withdrawn; "Sponsor elected not to conduct study at this time."
NCT00936598
terminated; "Investigator-initiated termination of approval due to problems with recruitment."
NCT01351168
withdrawn; "study not funded"
NCT02139098
terminated; "Recruiting problems because of the time expenditure required for participating and the strict criteria of inclusion and exclusion"
NCT03436745
terminated; "Slow/insufficient accrual"
1 further recorded trialNCT03657212
terminated; "Changed University from UCR to UCI. The new lab was not adequately equipped to handle the sleep research and it was too far from the main lab. Funding was running out."
recorded 2026-09-01 · last checked 2026-09-04
Q5
Human studies of Zolpidem used zolpidem tartrate sublingual tablet 3.5mg — over how long?
Zolpidem's half-life is 9.9 hr hours — which schedules were studied?
9.9 hr hours, the half-life Zolpidem's label states. openfda-label · cbda91f7-4411-4016-80d6-0a349931956d · 2026-08-30
Show the evidence
half life
9.9 hr hours; The mean half-life in cirrhotic patients of 9.9 hr (range: 4.1 to 25.8 hr) was greater than that observed in normal subjects of 2.2 hr (range: 1.6 to 2.4 hr) [see Dosage and Administration (2.2) , Warnings and Precautions (5.8) , Use in Specific Populations (8.7) ] .
tmax
Figure 1 Absorption Following administration of zolpidem tartrate extended-release tablets, administered as a single 12.5 mg dose in healthy male adult subjects, the mean peak concentration (C max ) of zolpidem was 134 ng/mL (range: 68.9 to 197 ng/ml) occurring at a median time (T max ) of 1.5 hours.
metabolism
Distribution Total protein binding was found to be 92.5 ± 0.1% and remained constant, independent of concentration between 40 and 790 ng/mL. Metabolism Zolpidem is converted to inactive metabolites that are eliminated primarily by renal excretion.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of assessment of clinical global impression change, assessment of fatigue and assessment of frequency and severity of adverse events did Zolpidem's trials measure?
assessment of clinical global impression change, assessment of fatigue and assessment of frequency and severity of adverse events lead 40 outcome terms across Zolpidem's trials. ClinicalTrials.gov · 2026-09-01
Interpretation diary sleep efficiency, choice reaction time, digit symbol substitution test, latency to persistent sleep measured by polysomnography, assessment of clinical global impression change and assessment of insomnia severity index follow.
Show the evidence
primary efficacy variable was the mean apnea hypopnea index
1
sleep latency
1
pittsburgh sleep quality index
1
diary sleep efficiency
1
choice reaction time
1
digit symbol substitution test
1
14 more recorded rows
latency to persistent sleep measured by polysomnography
1
assessment of clinical global impression change
1
assessment of insomnia severity index
1
assessment of pittsburgh sleep quality index
1
assessment of fatigue
1
assessment of sleepiness
1
polysomnography data
1
sensory organization test composite
1
bioequivalence
1
latency to persistent sleep
1
sleep efficiency
1
cmax maximum observed concentration
1
marijuana withdrawal
1
brief pain inventory
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Zolpidem's 7 ongoing trials reports first?
consolidation of episodic memory; Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling; latest 2032-01-01
Show the evidence
Trial
NCT04273776
"A Comparison of the Physiological and Behavioral Effects of Suvorexant and Zolpidem in Healthy Volunteers: A Randomized, Double-blind, Placebo Controlled Study"; n 90; "consolidation of episodic memory"; 2025-12-12
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
NCT05540574
"Trial of Zolpidem for Sleep in Children With Autism"; n 26; "Change from baseline in sleep architecture as measured by polysomnography (PSG) and/or actigraphy, examples include sleep latency and non-rapid eye movement (NREM)"; 2028-04-30
NCT05746143
"The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion"; n 140; "Visual analog scale (VAS)"; 2030-12-31
NCT06303076
"Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial"; n 90; "Pittsburgh Sleep Quality Index"; 2026-12
NCT07336277
"Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients"; n 30; "Total Sleep Time"; 2027-07
1 further recorded trialNCT07542756
"A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia"; n 1200; "Relative treatment response rates during acute (1-month) treatment phase"; 2032-01-01
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which 50 trials of Zolpidem posted no result?
Posted no result
50 of 50 completed trials
Registrations
NCT00630175, NCT00494468, NCT00601666, NCT00602719, NCT00530556 and NCT00779051, and 44 more
Completion dates
oldest 2004-02; newest 2023-05-12
Show the evidence
Trial
NCT00630175
2004-02
NCT00494468
2004-03
NCT00601666
2004-03
NCT00602719
2004-03
NCT00530556
2004-06
NCT00779051
2005-10
14 further recorded trials
NCT00779441
2005-11
NCT00425243
2006-01
NCT00283790
2006-04
NCT00292734
2006-06
NCT00044629
2006-08
NCT00318448
2006-08
NCT00568789
2006-09
NCT00296790
2007-02
NCT00999219
2007-07
NCT00440323
2007-07-03
NCT00227942
2007-11
NCT00283946
2007-11
NCT00374777
2008-06
NCT00716521
2008-10
Q10
At the median, Zolpidem's trials enrolled 52 people — anything larger?
Median enrolment
52
Largest enrolment
5000
Registered trials counted
120
Q11
What do 7468 spontaneous reports say about Zolpidem — 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.
Zolpidem appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 7468 reaction mentions were counted: drug abuse 1142; fall 884; somnolence 862; confusional state 806. open-targets-adr · CHEMBL3989820 · 2026-06-24
Show the evidence
drug abuse
1142
fall
884
somnolence
862
confusional state
806
suicide attempt
722
amnesia
683
4 more recorded rows
drug dependence
664
toxicity to various agents
632
coma
592
insomnia
481
recorded 2026-06-24 · last checked 2026-09-04
Q12
Zolpidem and CYP3A4, CYP1A2 and CYP2C9: shared by which compounds?
CYP3A4, CYP1A2 and CYP2C9 appear in Zolpidem's recorded interaction sentences, 6 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP1A2pharmacokinetics
Additionally, fluvoxamine (a strong inhibitor of CYP1A2 and a weak inhibitor of CYP3A4 and CYP2C9) and ciprofloxacin (a strong inhibitor of CYP1A2 and a moderate inhibitor of CYP3A4) are also likely to inhibit zolpidem's metabolic pathways, potentially leading to an increase in zolpidem exposure.
CYP2C9pharmacokinetics
Additionally, fluvoxamine (a strong inhibitor of CYP1A2 and a weak inhibitor of CYP3A4 and CYP2C9) and ciprofloxacin (a strong inhibitor of CYP1A2 and a moderate inhibitor of CYP3A4) are also likely to inhibit zolpidem's metabolic pathways, potentially leading to an increase in zolpidem exposure.
CYP3A4
pharmacokinetics
Rifampin, a CYP3A4 inducer, significantly reduced the exposure to and the pharmacodynamic effects of zolpidem [see Drug Interactions (7.2) ] .
pharmacokinetics
Similarly, St. John's wort, a CYP3A4 inducer, may also decrease the blood levels of zolpidem.
pharmacokinetics
A single-dose interaction study with zolpidem tartrate 5 mg and ketoconazole, a potent CYP3A4 inhibitor, given as 200 mg twice daily for 2 days increased C max of zolpidem (30%) and the total AUC of zolpidem (70%) compared to zolpidem alone and prolonged the elimination half-life (30%) along with an increase in the pharmacodynamic effects of zolpidem [see Drug Interactions (7.2) ] .
pharmacokinetics
Additionally, fluvoxamine (a strong inhibitor of CYP1A2 and a weak inhibitor of CYP3A4 and CYP2C9) and ciprofloxacin (a strong inhibitor of CYP1A2 and a moderate inhibitor of CYP3A4) are also likely to inhibit zolpidem's metabolic pathways, potentially leading to an increase in zolpidem exposure.
recorded 2026-08-30 · last checked 2026-09-04
Q13
Was Zolpidem studied with exercise?
exercise is named in Zolpidem's label sentences: "Exercise could provide a healthy alternative treatment for insomnia, particularly if it could be shown to have comparable efficacy to sleeping pills. <b>Objective</b> The purpose of this study was to compare the effects of acute exercise <i>versus</i> zolpidem on chronic insomnia. <b>Methods</b>…" openfda-label+europepmc · 2026-08-30
1 recorded statement; exercise
Show the evidence
exercise
Exercise could provide a healthy alternative treatment for insomnia, particularly if it could be shown to have comparable efficacy to sleeping pills. <b>Objective</b> The purpose of this study was to compare the effects of acute exercise <i>versus</i> zolpidem on chronic insomnia. <b>Methods</b> Seventeen participants with chronic insomnia (recruited from advertisements) participated in a…
recorded 2026-08-30 · last checked 2026-09-04
Q14
What is recorded about Zolpidem and sirtuin?
"A total of 99 active ingredients, 389 drug targets, 187 PI-related targets, and 15 drug-PI common targets were screened.The core active ingredients were armepavine, sanjoinenine and mairin, and the core targets included ESR1, SIRT1, SERPINE1, COMT and CCL2, which were involved in the positive regulation of transcription from RNA…" — where Zolpidem and sirtuin appear together. Europe PMC · pathway abstract search · 2023-09-01
sirtuin; PMID 37814868
Show the evidence
sirtuinPMID 37814868
"A total of 99 active ingredients, 389 drug targets, 187 PI-related targets, and 15 drug-PI common targets were screened.The core active ingredients were armepavine, sanjoinenine and mairin, and the core targets included ESR1, SIRT1, SERPINE1, COMT and CCL2, which were involved in the positive regulation of transcription from RNA polymerase II promoter, signal transduction, response to drug and…"
recorded 2023-09-01 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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
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✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 10 source rows
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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.