This page shows what was measured, who it was measured in, and what that does not settle.
What Suvorexant does in the body
Insomnia characterized by difficulties with sleep onset and/or sleep maintenance
From the FDA-approved label: The mechanism of action of suvorexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system plays a role in wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · 081L192FO9 · read 2026-08-29
Its recorded molecular formula is C23H23ClN6O2, weighing 450.92.
US prescribing information · e5b72731-1acb-45b7-9c13-290ad12d3951 · read 2026-08-30
Where each sentence above came from
The recorded explanation is written in label language rather than for a beginner. 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 80 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 32 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
∅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 reviewer2 registered symptom measure.
△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.
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.
Which registered measures put each goal on this table
Sleep
total sleep time; insomnia severity index from baseline; total sleep as assessed by the misfit shine device; sleep systolic blood pressure; insomnia severity index; subjective total sleep time; sleep efficiency
Focus
cue reactivity as assessed by the attention bias task; consolidation of episodic memory
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
2 registered symptom measure.
△ Only a number moved
1 registered test measure.
— 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.
enrollment
✗ The study did not show it
Who was studied
NCT06788522
How many people
40120
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
Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1
✗ The study did not show it
Who was studied
NCT01097616
How many people
1023
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
Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1
✗ The study did not show it
Who was studied
NCT01097629
How many people
1020
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
Percentage of Participants Who Experienced Cataplexy Adverse Events (AEs) During the Double-Blind (DB) Treatment Phase
✗ The study did not show it
Who was studied
NCT01021813
How many people
781
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 Total Sleep Time at Week 8
✗ The study did not show it
Who was studied
NCT06655883
How many people
300
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 Polysomnography-derived Total Sleep Time (TST) at Week 4
✗ The study did not show it
Who was studied
NCT02750306
How many people
285
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 eventNo evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
■Symptoms and quality of lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.3 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.1 registered measure 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. 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.
insomnia severity index from baseline
insomnia severity index
clinical global impression
Measured
Things only a test, a scale or a device shows.
sleep systolic blood pressure
Meaningful
Things that change how a life goes, not only a number.
No registered study measured anything of this kind.
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (28)
an adverse event
adverse events
apnea hypopnea index
who discontinued study drug due to an ae
total sleep time
who experienced one or more adverse events
who discontinued study drug due to an adverse event
cue reactivity as assessed by the attention bias task
total sleep as assessed by the misfit shine device
peak maximum effect for drug liking on a visual analog scale
clinician administered ptsd scale for dsm 5
sympathetic nerve activity
subjective total sleep time
reinforcing effects of cocaine
sleep efficiency
opioid abstinence
consolidation of episodic memory
psychomotor vigilance test
who discontinued study treatment due to an ae
peak maximum effect for drug liking visual analog scale
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to 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. 15 hours hours
Read from the label, which states: “dose was similar in patients with moderate hepatic insufficiency (Child-Pugh category 7 to 9) and healthy matched control subjects; however, the suvorexant apparent terminal half-life was increased from approximately 15 hours (range 10 - 22 hours) in healthy subjects to approximately 19 hours (range 11 - 49 hours) in patients with moderate hepatic insufficiency [see Use in Specific Populations (8.”
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.
BELSOMRA ® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. BELSOMRA is an orexin receptor antagonist indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance ( 1 ).
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “Safety and effectiveness in pediatric patients have not been established.”
US prescribing information · e5b72731-1acb-45b7-9c13-290ad12d3951 · read 2026-08-30
On older people, the label states: “Of the total number of patients treated with BELSOMRA (n=1784) in controlled clinical safety and efficacy studies, 829 patients were 65 years and over, and 159 patients were 75 years and over.”
US prescribing information · e5b72731-1acb-45b7-9c13-290ad12d3951 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Available data from postmarketing reports with BELSOMRA use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.”
US prescribing information · e5b72731-1acb-45b7-9c13-290ad12d3951 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Suvorexant and its metabolite, hydroxy suvorexant, are present in low concentrations in breast milk with a relative infant dose of less than 1% following maternal oral administration (see Data ) .”
US prescribing information · e5b72731-1acb-45b7-9c13-290ad12d3951 · 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
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
Sold as tablet, tablet, film coated, given by the oral route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to 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.
Suvorexant appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 936 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
somnolence — 141 reaction mentions
insomnia — 137 reaction mentions
nightmare — 119 reaction mentions
headache — 106 reaction mentions
feeling abnormal — 98 reaction mentions
wrong technique in product usage process — 83 reaction mentions
abnormal dreams — 73 reaction mentions
poor quality sleep — 67 reaction mentions
sleep disorder — 63 reaction mentions
anxiety — 49 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
16 products list this as an active ingredient in the United States drug directory. 16 of them contain it and nothing else.
FDA National Drug Code directory · 0006-0004 · read 2026-08-29
They are sold as powder and tablet, film coated, taken oral.
FDA National Drug Code directory · 0006-0004 · read 2026-08-29
The regulator's established pharmacologic class for it is cytochrome p450 3a inhibitors [moa], orexin receptor antagonist [epc] and orexin receptor antagonists [moa].
FDA National Drug Code directory · 0006-0004 · read 2026-08-29
1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · e5b72731-1acb-45b7-9c13-290ad12d3951 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · e5b72731-1acb-45b7-9c13-290ad12d3951 · read 2026-08-29
BELSOMRA is oral at 3 DOSAGE FORMS AND STRENGTHS 5 mg tablets are yellow, round, film-coated tablets with "5" on one side and plain on the other side. 10 mg tablets are green, round, film-coated tablets with "33" on one side and plain on t…, recorded as fda label in effect 2025-03-10 in the United States.
US prescribing information · e5b72731-1acb-45b7-9c13-290ad12d3951 · read 2026-08-30
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.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Suvorexant 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 Suvorexant 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
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Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
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FDA substance identifier (UNII)
081L192FO9
RxNorm concept
1547104
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2 approved applications cover products containing this substance. The earliest was NDA204569, approved 20140813 to MERCK SHARP DOHME.
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5 questions this page could not answer
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Recorded evidence blocks (13)
Q1
What did Suvorexant's largest trial (40120 people) and its longest (7.3 years) measure?
40120 people in Suvorexant's largest registered study, 7.3 years in its longest registered window, measuring Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-∞) After Single Dose Suvorexant: Moderate Hepatic Insufficiency Participants Versus Healthy Participants… ClinicalTrials.gov · 2026-09-01
26 phase4, 20 phase2, 10 phase1, 7 phase3, 5 early phase1, 2 na; NCT03999099; 2026-12-31; no ageing endpoint recorded. Last human test completed 2026, NCT05145764.
Interpretation These counts include studies where Suvorexant 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
26
phase2
20
phase1
10
phase3
7
early phase1
5
na
2
1 more recorded row
Last recorded human testNCT05145764
2026-08-03
recorded 2026-09-01 · last checked 2026-09-04
Q2
From mouse to human: where has Suvorexant shown healthspan?
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-∞) After Single Dose Suvorexant: Moderate Hepatic Insufficiency… — the recorded outcome words.
Show the evidence
mouse
healthspan
humanNCT01043926
biomarker; Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-∞) After Single Dose Suvorexant: Moderate Hepatic Insufficiency Participants Versus Healthy Participants (Part I); 68
recorded 2026-09-01 · last checked 2026-09-04
Q3
7 of Suvorexant's trials stopped: futility/efficacy, accrual/recruitment, other?
futility/efficacy (1), accrual/recruitment (4) and other (2): Suvorexant's stop wording, clustered. ClinicalTrials.gov · 2026-09-01
"reduced ability to recruit sufficient number of patients"; 7 of 68 registered studies
Show the evidence
Trial
NCT02684136
terminated; "reduced ability to recruit sufficient number of patients"
NCT03764683
withdrawn; "Study was terminated due to COVID-19."
NCT03897062
terminated; "Recruitment problems during covid lockdowns resulted in Merck ceasing supply of suvorexant/placebo"
NCT04262193
terminated; "Did not meet enrollment goals."
NCT05711862
terminated; "Lack of enrollment"
NCT06162663
terminated; "Terminated early due to insufficient accrual to meet prespecified statistical analysis requirements."
1 further recorded trialNCT06834386
withdrawn; "low/slow accrual"
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Suvorexant used MK-4305 40 mg — over how long?
8 recorded entries; human; also "MK-4305 20 mg", "Suvorexant 10 mg", "belsomra 10mg"
Show the evidence
human
NCT01311882
MK-4305 40 mg
NCT01311882
MK-4305 20 mg
NCT03312517
Suvorexant 10 mg
NCT03312517
belsomra 10mg
NCT03312517
Suvorexant 20 mg
NCT03312517
Belsomra 20mg
2 more recorded rows
humanNCT04234997
Suvorexant 0mg
humanNCT05829655
Suvorexant (20mg/day)
recorded 2026-09-01 · last checked 2026-09-04
Q5
Suvorexant's half-life is 15 hours — which schedules were studied?
15 hours, the half-life Suvorexant's label states. openfda-label · e5b72731-1acb-45b7-9c13-290ad12d3951 · 2026-08-30
bioavailability 82% %.
Show the evidence
half life
15 hours hours; dose was similar in patients with moderate hepatic insufficiency (Child-Pugh category 7 to 9) and healthy matched control subjects; however, the suvorexant apparent terminal half-life was increased from approximately 15 hours (range 10 - 22 hours) in healthy subjects to approximately 19 hours (range 11 - 49 hours) in patients with moderate hepatic insufficiency [see Use in Specific Populations (8.
tmax
Absorption Suvorexant peak concentrations occur at a median T max of 2 hours (range 30 minutes to 6 hours) under fasted conditions.
bioavailability
82% %; The mean absolute bioavailability of 10 mg is 82%.
metabolism
Elimination Metabolism Suvorexant is mainly eliminated by metabolism, primarily by CYP3A with a minor contribution from CYP2C19.
recorded 2026-08-30 · last checked 2026-09-04
Q6
Could one person measure Suvorexant's effect on an adverse event?
An adverse event: measured in Suvorexant's trials.
Interpretation an adverse event is the recorded endpoint.
Show the evidence
biomarkers
an adverse event; 2026-09-01
adverse events; 2026-09-01
apnea hypopnea index; 2026-09-01
who discontinued study drug due to an ae; 2026-09-01
total sleep time; 2026-09-01
insomnia severity index from baseline; 2026-09-01
14 more recorded rows
biomarkers
who experienced one or more adverse events; 2026-09-01
biomarkers
who discontinued study drug due to an adverse event; 2026-09-01
biomarkers
cue reactivity as assessed by the attention bias task; 2026-09-01
biomarkers
total sleep as assessed by the misfit shine device; 2026-09-01
biomarkers
sleep systolic blood pressure; 2026-09-01
biomarkers
insomnia severity index; 2026-09-01
biomarkers
peak maximum effect for drug liking on a visual analog scale; 2026-09-01
biomarkers
clinician administered ptsd scale for dsm 5; 2026-09-01
biomarkers
sympathetic nerve activity; 2026-09-01
biomarkers
subjective total sleep time; 2026-09-01
biomarkers
reinforcing effects of cocaine; 2026-09-01
biomarkers
sleep efficiency; 2026-09-01
biomarkers
clinical global impression; 2026-09-01
biomarkers
opioid abstinence; 2026-09-01
half life
2026-09-04; halfLife; hours; 15 hours; 2026-08-30
human trials at or under30
26
smallest human trial
0; NCT03764683; PHASE4; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN
Q7
Which of adverse events, an adverse event and apnea hypopnea index did Suvorexant's trials measure?
adverse events, an adverse event and apnea hypopnea index lead 32 outcome terms across Suvorexant's trials. ClinicalTrials.gov · 2026-09-01
Interpretation who discontinued study drug due to an ae, total sleep time, insomnia severity index from baseline, who experienced one or more adverse events, who discontinued study drug due to an adverse event and cue reactivity as assessed by the attention bias task follow.
Show the evidence
an adverse event
1
adverse events
1
apnea hypopnea index
1
who discontinued study drug due to an ae
1
total sleep time
1
insomnia severity index from baseline
1
14 more recorded rows
who experienced one or more adverse events
1
who discontinued study drug due to an adverse event
1
cue reactivity as assessed by the attention bias task
1
total sleep as assessed by the misfit shine device
1
sleep systolic blood pressure
1
insomnia severity index
1
peak maximum effect for drug liking on a visual analog scale
1
clinician administered ptsd scale for dsm 5
1
sympathetic nerve activity
1
subjective total sleep time
1
reinforcing effects of cocaine
1
sleep efficiency
1
clinical global impression
1
opioid abstinence
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Suvorexant's 15 ongoing trials reports first?
Insomnia Severity Index (ISI); Nicotine Craving; latest 2032-06-30
Show the evidence
Trial
NCT03642028
"Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress"; n 190; "Insomnia Severity Index (ISI)"; 2025-12-31
NCT03999099
"Targeting Orexin to Treat Nicotine Dependence"; n 45; "Nicotine Craving"; 2026-12-31
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
NCT04629547
"Sleep Trial to Prevent Alzheimer's Disease"; n 120; "Change from baseline in Amyloid-β accumulation measured by plasma pT217/T217 in participants treated with 20 mg suvorexant compared to placebo"; 2028-05
NCT05546554
"Trial of Suvorexant 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)"; 2028-02-28
NCT05630781
"Orexin s Role in the Neurobiology of Substance Use Disorder"; n 140; "fMRI - cue reactivity"; 2027-12-31
9 further recorded trials
NCT05829655
"Measuring Acute Drug Demand in Humans"; n 75; "Demand Intensity"; 2028-01-01
NCT06326684
"Suvorexant and Alcohol"; n 30; "Reinforcing Effects of Alcohol"; 2027-03-15
NCT06484075
"Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms"; n 180; "To examine the impact of suvorexant on dopamine receptors in adults with AUD undergoing detoxification and to compare against baseline measures in healthy controls."; 2029-12-31
NCT06655883
"A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)"; n 300; "Change from Baseline in Total Sleep Time at Week 8"; 2027-06-24
NCT06679062
"Suvorexant for Treatment of AUD and PTSD"; n 76; "Change in Insomnia Severity Index (ISI) score from baseline to Day 14."; 2027-03
NCT06788522
"The Effects of Orexin Antagonism on Fear Extinction in PTSD"; n 40120; "enrollment"; 2032-06-30
NCT06854224
"Orexin Antagonism for Suicide Risk: A Proof-of-Concept Clinical Trial"; n 30; "Implicit Association Tests (IATs)"; 2027-07-01
NCT07214207
"Orexin Receptor Antagonism for the Treatment of Alcohol Use Disorder and Stress-Related Drinking"; n 250; "Proportion of Heavy Drinking Days"; 2030-09
NCT07686731
"Suvorexant 3 - PE-PC"; n 142; "Change from Baseline in PTSD Symptom Severity as Assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at Week 4, Week 8, and 6 Months"; 2029-08-30
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which 4 trials of Suvorexant posted no result?
Posted no result
4 of 4 completed trials
Registrations
NCT01311882, NCT03158025, NCT03657355 and NCT05106153
Completion dates
oldest 2011-11; newest 2023-05-12
Show the evidence
Trial
NCT01311882
2011-11
NCT03158025
2018-07-04
NCT03657355
2019-08-08
NCT05106153
2023-05-12
Q10
At the median, Suvorexant's trials enrolled 42 people — anything larger?
Median enrolment
42
Largest enrolment
40120
Registered trials counted
68
Q11
What do 936 spontaneous reports say about Suvorexant — 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.
Suvorexant appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 936 reaction mentions were counted: somnolence 141; insomnia 137; nightmare 119; headache 106. open-targets-adr · CHEMBL1083659 · 2026-06-24
Show the evidence
somnolence
141
insomnia
137
nightmare
119
headache
106
feeling abnormal
98
wrong technique in product usage process
83
4 more recorded rows
abnormal dreams
73
poor quality sleep
67
sleep disorder
63
anxiety
49
recorded 2026-06-24 · last checked 2026-09-04
Q12
Suvorexant and CYP2C19, BCRP and CYP1A2: shared by which compounds?
CYP2C19, BCRP and CYP1A2 appear in Suvorexant's recorded interaction sentences, 7 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP1A2pharmacokinetics
Figure 1: Effects of Co-Administered Drugs on the Pharmacokinetics of Suvorexant Figure 1 Effects of BELSOMRA on Other Drugs In vitro metabolism studies demonstrate that suvorexant has the potential to inhibit CYP3A and intestinal P-gp; however, suvorexant is unlikely to cause clinically significant inhibition of human CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or CYP2D6.
CYP2B6pharmacokinetics
Figure 1: Effects of Co-Administered Drugs on the Pharmacokinetics of Suvorexant Figure 1 Effects of BELSOMRA on Other Drugs In vitro metabolism studies demonstrate that suvorexant has the potential to inhibit CYP3A and intestinal P-gp; however, suvorexant is unlikely to cause clinically significant inhibition of human CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or CYP2D6.
CYP2C19
pharmacokinetics
Elimination Metabolism Suvorexant is mainly eliminated by metabolism, primarily by CYP3A with a minor contribution from CYP2C19.
pharmacokinetics
Figure 1: Effects of Co-Administered Drugs on the Pharmacokinetics of Suvorexant Figure 1 Effects of BELSOMRA on Other Drugs In vitro metabolism studies demonstrate that suvorexant has the potential to inhibit CYP3A and intestinal P-gp; however, suvorexant is unlikely to cause clinically significant inhibition of human CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or CYP2D6.
CYP2C8pharmacokinetics
Figure 1: Effects of Co-Administered Drugs on the Pharmacokinetics of Suvorexant Figure 1 Effects of BELSOMRA on Other Drugs In vitro metabolism studies demonstrate that suvorexant has the potential to inhibit CYP3A and intestinal P-gp; however, suvorexant is unlikely to cause clinically significant inhibition of human CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or CYP2D6.
CYP2C9pharmacokinetics
Figure 1: Effects of Co-Administered Drugs on the Pharmacokinetics of Suvorexant Figure 1 Effects of BELSOMRA on Other Drugs In vitro metabolism studies demonstrate that suvorexant has the potential to inhibit CYP3A and intestinal P-gp; however, suvorexant is unlikely to cause clinically significant inhibition of human CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or CYP2D6.
CYP2D6pharmacokinetics
Figure 1: Effects of Co-Administered Drugs on the Pharmacokinetics of Suvorexant Figure 1 Effects of BELSOMRA on Other Drugs In vitro metabolism studies demonstrate that suvorexant has the potential to inhibit CYP3A and intestinal P-gp; however, suvorexant is unlikely to cause clinically significant inhibition of human CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or CYP2D6.
recorded 2026-08-30 · last checked 2026-09-04
Q13
What is recorded about Suvorexant and mTOR?
"Mitochondrial dysfunction and mTOR activation, observed in rodent models of PTSD, were normalized with suvorexant treatment, suggesting cellular resilience." — where Suvorexant and mTOR appear together. Europe PMC · pathway abstract search · 2026-07-02
mTOR; PMID 42391109, 38185385
Show the evidence
mTOR
PMID 42391109
"Mitochondrial dysfunction and mTOR activation, observed in rodent models of PTSD, were normalized with suvorexant treatment, suggesting cellular resilience."
PMID 38185385
"Further, suvorexant in combination with rapamycin significantly mitigated mTOR and MTFP-1 activation."
recorded 2026-07-02 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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✓ source coverage passed: 11 source rows
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