This page shows what was measured, who it was measured in, and what that does not settle.
What Daridorexant does in the body
Insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies (14
From the FDA-approved label: The mechanism of action of daridorexant 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 · LMQ24G57E9 · read 2026-08-29
Its recorded molecular formula is C23H23N6O2Cl, weighing 487.38 g/mol.
US prescribing information · 3a2d1503-b816-40c9-9fac-7e03c5a3bcef · 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 84 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
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 22 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 reviewer3 registered symptom measure.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Sleep
wake after sleep onset from baseline to days 1 and 2; total sleep time; subjective total sleep time; promis sleep disturbance t; sleep quality; insomnia severity index; pittsburgh sleep quality index
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
… Waiting for a reviewer
3 registered symptom measure.
— Not recorded
Harms were not a registered measure for this goal.
What happened in 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.
PROMIS Sleep Disturbance T-score
✗ The study did not show it
Who was studied
NCT07136415
How many people
1000
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
Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance)
✗ The study did not show it
Who was studied
NCT03545191
How many people
930
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 Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance)
✗ The study did not show it
Who was studied
NCT03575104
How many people
924
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
Total no. of Subjects With at Least One TEAE
✗ The study did not show it
Who was studied
NCT03679884
How many people
804
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
Absolute change in the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) Past Month total score at Week 12 (Final/Early termination Visit).
✗ The study did not show it
Who was studied
NCT05422612
How many people
800
Study design
Phase 2
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 in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2
✗ The study did not show it
Who was studied
NCT02839200
How many people
360
Study design
Phase 2
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.4 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.3 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.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□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.
quality of life
sleep quality
insomnia severity index
pittsburgh sleep quality index
Measured
Things only a test, a scale or a device shows.
maximum plasma concentration of midazolam
maximum plasma concentration of 1 hydroxymidazolam
maximum plasma concentration of dabigatran
Meaningful
Things that change how a life goes, not only a number.
No registered study measured anything of this kind.
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (15)
adverse events
wake after sleep onset from baseline to days 1 and 2
treatment emergent adverse events and serious adverse events
treatment emergent adverse events
treatment emergent serious adverse events
cmax of rosuvastatin
cmax of s warfarin
tmax of s warfarin
cmax
auc0 t
total sleep time
delirium
subjective total sleep time
promis sleep disturbance t
karolinska sleepiness scale
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to 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. 8 hours hours
Read from the label, which states: “Elimination The terminal half-life of daridorexant is approximately 8 hours.”
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.
QUVIVIQ is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies (14.1) ]. QUVIVIQ is an orexin receptor antagonist indicated for the treatment of adult patients with 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: “The safety and effectiveness of QUVIVIQ have not been established in pediatric patients.”
US prescribing information · 3a2d1503-b816-40c9-9fac-7e03c5a3bcef · read 2026-08-30
On older people, the label states: “No dose adjustment is required in patients over the age of 65 years.”
US prescribing information · 3a2d1503-b816-40c9-9fac-7e03c5a3bcef · read 2026-08-30
On people who are pregnant, the label states: “Exposure Registry There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to QUVIVIQ during pregnancy.”
US prescribing information · 3a2d1503-b816-40c9-9fac-7e03c5a3bcef · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Daridorexant is present in human breast milk in low amounts.”
US prescribing information · 3a2d1503-b816-40c9-9fac-7e03c5a3bcef · read 2026-08-30
On people with reduced liver function, the label states: “QUVIVIQ has not been studied in patients with severe hepatic impairment (Child-Pugh score ≥ 10).”
US prescribing information · 3a2d1503-b816-40c9-9fac-7e03c5a3bcef · 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.
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
5 products list this as an active ingredient in the United States drug directory. 5 of them contain it and nothing else.
FDA National Drug Code directory · 71666-020 · read 2026-08-29
They are sold as powder and tablet, film coated, taken oral.
FDA National Drug Code directory · 71666-020 · read 2026-08-29
The regulator's established pharmacologic class for it is orexin receptor antagonist [epc] and orexin receptor antagonists [moa].
FDA National Drug Code directory · 71666-020 · 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 · 3a2d1503-b816-40c9-9fac-7e03c5a3bcef · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 3a2d1503-b816-40c9-9fac-7e03c5a3bcef · read 2026-08-29
QUVIVIQ is oral at 3 DOSAGE FORMS AND STRENGTHS QUVIVIQ (daridorexant) tablets are available as: 25 mg: light purple, arc-triangle shaped, film-coated tablet debossed with "25" on one side and "i" (Idorsia logo) on the other side, contain…, recorded as fda label in effect 2026-02-26 in the United States.
US prescribing information · 3a2d1503-b816-40c9-9fac-7e03c5a3bcef · 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 Daridorexant 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 Daridorexant 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.
Where else this substance is registered
FDA substance identifier (UNII)
LMQ24G57E9
RxNorm concept
2591502
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Written into the record, not signed off.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✗ Not passed
Safety mode resolved
No register row and no identity class settled the question.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or 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
1 approved application covers products containing this substance. The earliest was NDA214985, approved 20220107 to IDORSIA.
This order is fixed in code and does not count clicks or time on the page.
What is not here
5 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
The path through the body — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
Claims that go past the evidence — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
Recorded evidence blocks (10)
Q1
What did Daridorexant's largest trial (2095 people) and its longest (8.3 years) measure?
2095 people in Daridorexant's largest registered study, 8.3 years in its longest registered window, measuring Maximum plasma concentration (Cmax) of ACT-541468. ClinicalTrials.gov · 2026-09-01
23 phase1, 8 phase2, 7 phase4, 5 phase3, 4 na or unstated, 1 na; NCT06498128; 2033-03; no ageing endpoint recorded. Last human test completed 2026, NCT06311864.
Interpretation These counts include studies where Daridorexant 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.
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phase1
23
phase2
8
phase4
7
phase3
5
na or unstated
4
na
1
1 more recorded row
Last recorded human testNCT06311864
2026-05-19
recorded 2026-09-01 · last checked 2026-09-04
Q2
Daridorexant was tested only in human — what did it show?
8 recorded entries; human; orally; also "Daridorexant 25 mg", "Daridorexant 50 mg", "Daridorexant 10 mg"
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human
NCT02839200
ACT-541468 10 mg
NCT03545191
Daridorexant 25 mg
NCT03545191
Daridorexant 50 mg
NCT03679884
Daridorexant 10 mg
NCT03713242
ACT-541468 25 mg
NCT03713242
ACT-541468 25 mg (or 10 mg depending on interim results)
2 more recorded rows
humanNCT07132086
orally; Daridorexant 50 mg orally, once daily at bedtime, administered as monotherapy or add-on therapy for chronic insomnia, in a real-world, observational, prospective clinical setting
humanNCT07132086
Quviviq 50 mg
recorded 2026-09-01 · last checked 2026-09-04
Q4
Daridorexant's half-life is 8 hours — which schedules were studied?
8 hours, the half-life Daridorexant's label states. openfda-label · 3a2d1503-b816-40c9-9fac-7e03c5a3bcef · 2026-08-30
bioavailability 62% %.
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half life
8 hours hours; Elimination The terminal half-life of daridorexant is approximately 8 hours.
tmax
Absorption Daridorexant reaches peak plasma concentrations within 1–2 hours (T max ).
bioavailability
62% %; Daridorexant has an absolute bioavailability of 62%.
metabolism
Metabolism Daridorexant undergoes extensive metabolism and is primarily metabolized by CYP3A4 (89%).
recorded 2026-08-30 · last checked 2026-09-04
Q5
Could one person measure Daridorexant's effect on adverse events?
Adverse events: measured in Daridorexant's trials.
Interpretation adverse events is the recorded endpoint.
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biomarkers
adverse events; 2026-09-01
wake after sleep onset from baseline to days 1 and 2; 2026-09-01
treatment emergent adverse events and serious adverse events; 2026-09-01
maximum plasma concentration of midazolam; 2026-09-01
maximum plasma concentration of 1 hydroxymidazolam; 2026-09-01
maximum plasma concentration of midazolam, maximum plasma concentration of 1 hydroxymidazolam, treatment emergent adverse events, treatment emergent serious adverse events, maximum plasma concentration of dabigatran and cmax of rosuvastatin follow.
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adverse events
1
wake after sleep onset from baseline to days 1 and 2
1
treatment emergent adverse events and serious adverse events
1
maximum plasma concentration of midazolam
1
maximum plasma concentration of 1 hydroxymidazolam
1
treatment emergent adverse events
1
14 more recorded rows
treatment emergent serious adverse events
1
maximum plasma concentration of dabigatran
1
cmax of rosuvastatin
1
cmax of s warfarin
1
tmax of s warfarin
1
cmax
1
auc0 t
1
total sleep time
1
quality of life
1
delirium
1
subjective total sleep time
1
promis sleep disturbance t
1
sleep quality
1
insomnia severity index
1
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which of Daridorexant's 13 ongoing trials reports first?
Change in Total Sleep Time (TST).; Prevalence of major congenital malformations (MCMs); latest 2033-03
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Trial
NCT05924425
"Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease"; n 62; "Change in Total Sleep Time (TST)."; 2028-03-13
NCT06393504
"Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)"; n 2095; "Prevalence of major congenital malformations (MCMs)"; 2028-04
NCT06498128
"Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ®"; n 785; "Major congenital malformations classified according to MACDP"; 2033-03
NCT07136415
"Comparing Digital Therapy, Trazodone, and Daridorexant for Menopause-Related Insomnia Symptoms"; n 1000; "PROMIS Sleep Disturbance T-score"; 2031-02
NCT07213349
"Daridorexant for Alzheimer Disease Prevention"; n 240; "Change in plasma p-tau217/np-tau217 ratio"; 2029-12
NCT07217912
"Daridorexant to Prevent Post-cardiotomy Delirium"; n 80; "Delirium incidence and severity"; 2027-11-01
7 further recorded trials
NCT07267559
"Dual Orexin Antagonism and Emotion and Affective Processing Study"; n 62; "Pavlovian Aversive Learning Task Computational Parameter Estimates"; 2026-10-01
NCT07328594
"Impact of Daridorexant on Sleep, Daytime Alertness, and Smoking"; n 44; "Sleep Quality"; 2027-09-30
NCT07532252
"Daridorexant for Alcohol Use Disorder"; n 150; "Total Sleep Time (Minutes)"; 2031-02-01
NCT07555743
"Efficacy and Safety of Daridorexant in Patients With Major Depressive Disorder and Insomnia"; n 134; "Insomnia Severity Index (ISI)"; 2028-10
NCT07701928
"Daridorexant for People With Insomnia and Alcohol Use Disorder Study"; n 205; "Self-Reported Drinks Per Day and Heavy Drinking Days"; 2031-12
NCT07733414
"Evaluating the Efficacy and Safety of Daridorexant Transition From BZRAs in Insomnia Patients（EASY-TIP）"; n 156; "Proportion of Participants Successfully Transitioning from BZRAs to Daridorexant at Week 5"; 2030-12-01
NCT07743931
"Study on the Management of COMISA"; n 150; "To evaluate, in patients diagnosed with COMISA and treated with CPAP, the impact of daridorexant on CPAP adherence at 4 months compared with patients not receiving daridorexant."; 2029-02
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which 24 trials of Daridorexant posted no result?
Posted no result
24 of 24 completed trials
Registrations
NCT02919319, NCT02526888, NCT02571855, NCT03017495, NCT03101189 and NCT03339752, and 18 more
Completion dates
oldest 2015-05-01; newest 2024-05-10
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Trial
NCT02919319
2015-05-01
NCT02526888
2015-11-01
NCT02571855
2016-02-01
NCT03017495
2017-02-01
NCT03101189
2017-04-26
NCT03339752
2017-12-02
14 further recorded trials
NCT03609775
2018-10-09
NCT03799978
2019-03-18
NCT03657355
2019-08-08
NCT03646864
2019-09-19
NCT03892902
2019-10-10
NCT03765294
2019-11-05
NCT03713242
2020-02-27
NCT04390334
2020-06-26
NCT04250506
2020-07-22
NCT04024332
2020-08-14
NCT05480475
2022-09-17
NCT05480488
2022-10-06
NCT05458193
2023-02-28
NCT05702177
2023-04-25
Q9
At the median, Daridorexant's trials enrolled 57 people — anything larger?
Median enrolment
57
Largest enrolment
2095
Registered trials counted
48
Q10
Daridorexant and CYP3A4, BCRP and P-GLYCOPROTEIN: shared by which compounds?
CYP3A4, BCRP and P-GLYCOPROTEIN appear in Daridorexant's recorded interaction sentences, 3 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP3A4
pharmacokinetics
Metabolism Daridorexant undergoes extensive metabolism and is primarily metabolized by CYP3A4 (89%).
pharmacokinetics
Concomitant use of rifampin (a strong CYP3A4 inducer) decreased daridorexant AUC by more than 50%.
pharmacokinetics
Based on PBPK analysis: Concomitant use of itraconazole (a strong CYP3A4 inhibitor) increased daridorexant AUC by more than 400%.
recorded 2026-08-30 · 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 · 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
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 8 source rows
✓ no critical contamination: no quarantine open
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