Drug · FAERS side-effect profile with label screen
Daridorexant side effects: what 2,574 FDA adverse event reports show
Brand names
Quviviq
openFDA label
Who reports
2,574 reports · 32% serious · 67 with death outcome · 65% female
openFDA FAERS counts, all years, deduplication not applied
Used for
QUVIVIQ is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance . 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 )
FDA label, Indications and Usage
What it is
QUVIVIQ contains daridorexant, an orexin receptor antagonist, present as daridorexant hydrochloride salt.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 8Labeled (related wording) 1Likely indication confounding 3Reporting / coding artifact 7Not in label — unassessed 21
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 44 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Nightmare | 275 | 65.0 58.1–72.7ROR 72.6 · χ² 17,144 / p <1e-300 | 64.2 EB05 58.1 · IC025 +5.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.8 · 74% consumer | no trial data cached |
| Product availability issue | 148 | 54.1 46.3–63.3ROR 57.4 · χ² 7,622 / p <1e-300 | 53.4 EB05 46.6 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 · 98% consumer | no trial data cached |
| Abnormal dreams | 137 | 40.3 34.3–47.5ROR 42.6 · χ² 5,198 / p <1e-300 | 39.9 EB05 34.6 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.1 · 79% consumer | no trial data cached |
| Brain fog | 44 | 24.6 18.4–33.0ROR 25.1 · χ² 972 / p 1e-213 | 24.3 EB05 18.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · 91% consumer | no trial data cached |
| Middle insomnia | 55 | 24.2 18.6–31.4ROR 24.7 · χ² 1,195 / p 3e-262 | 23.9 EB05 19.1 · IC025 +3.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 3.4 · 93% consumer | no trial data cached |
| Poisoning deliberate | 25 | 21.9 14.8–32.4ROR 22.1 · χ² 478 / p 3e-106 | 21.6 EB05 15.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 39.5 · 100% clinician | no trial data cached |
| Initial insomnia | 19 | 15.2 9.7–23.8ROR 15.3 · χ² 238 / p 6e-54 | 14.6 EB05 9.4 · IC025 +2.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=3 | no trial data cached |
| Poor quality sleep | 37 | 14.1 10.2–19.4ROR 14.3 · χ² 437 / p 2e-97 | 13.8 EB05 10.3 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.3 · 84% consumer | no trial data cached |
| Paralysis | 18 | 10.2 6.4–16.2ROR 10.3 · χ² 140 / p 1e-32 | 9.1 EB05 5.7 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.0 | no trial data cached |
| Insomnia (trouble sleeping) | 315 | 9.6 8.7–10.7ROR 10.8 · χ² 2,456 / p <1e-300 | 9.6 EB05 8.7 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.9 · 91% consumer | no trial data cached |
| Impaired driving ability | 13 | 9.3 5.4–16.0ROR 9.4 · χ² 88 / p 3e-21 | 7.7 EB05 4.6 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 | no trial data cached |
| Therapeutic product effect incomplete | 78 | 9.0 7.2–11.2ROR 9.2 · χ² 548 / p 2e-121 | 8.7 EB05 7.2 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 1.6 · 88% consumer | no trial data cached |
| Sluggishness | 11 | 8.8 4.9–15.9ROR 8.9 · χ² 69 / p 6e-17 | 7.0 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Nocturia (night-time urination) | 13 | 8.8 5.1–15.1ROR 8.8 · χ² 82 / p 8e-20 | 7.2 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Restless legs syndrome | 19 | 8.5 5.4–13.3ROR 8.6 · χ² 118 / p 7e-28 | 7.4 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Hallucination (hallucinations) | 76 | 8.3 6.6–10.3ROR 8.5 · χ² 479 / p 1e-106 | 8.0 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 · 71% consumer | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 89 | 7.9 6.5–9.7ROR 8.2 · χ² 533 / p 4e-118 | 7.7 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.8 | no trial data cached |
| Intentional overdose | 59 | 7.5 5.9–9.7ROR 7.7 · χ² 329 / p 7e-74 | 7.2 EB05 5.8 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 | no trial data cached |
| Restlessness | 33 | 7.3 5.2–10.3ROR 7.4 · χ² 175 / p 4e-40 | 6.8 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 1.7 · 94% consumer | no trial data cached |
| Somnolence (drowsiness) | 170 | 6.9 6.0–8.0ROR 7.3 · χ² 858 / p 6e-189 | 6.8 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 79% consumer | no trial data cached |
| Loss of personal independence in daily activities | 37 | 6.3 4.6–8.7ROR 6.4 · χ² 161 / p 3e-37 | 5.9 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 85% consumer | no trial data cached |
| Therapeutic product effect decreased | 33 | 6.1 4.3–8.5ROR 6.1 · χ² 135 / p 2e-31 | 5.6 EB05 4.2 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 1.3 · 94% consumer | no trial data cached |
| Product prescribing issue | 15 | 6.0 3.6–10.0ROR 6.0 · χ² 58 / p 2e-14 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 | no trial data cached |
| Hypersomnia | 21 | 6.0 3.9–9.2ROR 6.0 · χ² 82 / p 6e-20 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
| Mania | 12 | 6.0 3.4–10.5ROR 6.0 · χ² 45 / p 1e-11 | 4.9 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 | no trial data cached |
| Night sweats | 23 | 5.8 3.9–8.7ROR 5.9 · χ² 87 / p 5e-21 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Dysarthria (slurred speech) | 26 | 5.6 3.8–8.3ROR 5.7 · χ² 95 / p 1e-22 | 5.2 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 · 85% consumer | no trial data cached |
| Inappropriate schedule of product administration | 121 | 5.6 4.7–6.6ROR 5.8 · χ² 454 / p 6e-101 | 5.5 EB05 4.7 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 · 91% consumer | no trial data cached |
| Disturbance in attention | 37 | 5.6 4.0–7.7ROR 5.6 · χ² 135 / p 2e-31 | 5.2 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · 78% consumer | no trial data cached |
| Feeling jittery | 13 | 5.5 3.2–9.5ROR 5.6 · χ² 44 / p 2e-11 | 4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Hallucination, visual | 14 | 5.4 3.2–9.2ROR 5.5 · χ² 46 / p 5e-12 | 4.7 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 18 | 5.1 3.2–8.2ROR 5.2 · χ² 56 / p 3e-14 | 4.6 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 | no trial data cached |
| Fibromyalgia | 15 | 5.0 3.0–8.3ROR 5.1 · χ² 45 / p 1e-11 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 | no trial data cached |
| Muscle twitching | 13 | 4.6 2.7–7.9ROR 4.6 · χ² 33 / p 5e-9 | 4.0 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Agitation | 40 | 4.4 3.3–6.0ROR 4.5 · χ² 103 / p 2e-24 | 4.2 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 1.3 · 80% consumer | no trial data cached |
| Serotonin syndrome | 10 | 4.3 2.3–7.9ROR 4.3 · χ² 22 / p 2e-6 | 3.6 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Feeling abnormal | 122 | 4.1 3.5–4.9ROR 4.3 · χ² 290 / p 3e-65 | 4.1 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 · 84% consumer | no trial data cached |
| Coma | 24 | 4.1 2.8–6.1ROR 4.1 · χ² 53 / p 1e-13 | 3.8 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Anger | 16 | 3.8 2.4–6.3ROR 3.9 · χ² 31 / p 1e-8 | 3.5 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Sedation | 12 | 3.8 2.1–6.6ROR 3.8 · χ² 22 / p 2e-6 | 3.3 EB05 2.1 · IC025 +0.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Insomnia (trouble sleeping) | 315 | 9.6 8.7–10.7ROR 10.8 · χ² 2,456 / p <1e-300 | 9.6 EB05 8.7 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.9 · 91% consumer | no trial data cached |
| Nightmare | 275 | 65.0 58.1–72.7ROR 72.6 · χ² 17,144 / p <1e-300 | 64.2 EB05 58.1 · IC025 +5.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.8 · 74% consumer | no trial data cached |
| Somnolence (drowsiness) | 170 | 6.9 6.0–8.0ROR 7.3 · χ² 858 / p 6e-189 | 6.8 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 79% consumer | no trial data cached |
| Product availability issue | 148 | 54.1 46.3–63.3ROR 57.4 · χ² 7,622 / p <1e-300 | 53.4 EB05 46.6 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 · 98% consumer | no trial data cached |
| Abnormal dreams | 137 | 40.3 34.3–47.5ROR 42.6 · χ² 5,198 / p <1e-300 | 39.9 EB05 34.6 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.1 · 79% consumer | no trial data cached |
| Feeling abnormal | 122 | 4.1 3.5–4.9ROR 4.3 · χ² 290 / p 3e-65 | 4.1 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 · 84% consumer | no trial data cached |
| Inappropriate schedule of product administration | 121 | 5.6 4.7–6.6ROR 5.8 · χ² 454 / p 6e-101 | 5.5 EB05 4.7 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 · 91% consumer | no trial data cached |
| Wrong technique in product usage process | 89 | 3.6 2.9–4.4ROR 3.7 · χ² 165 / p 4e-38 | 3.5 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 · 90% consumer | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 89 | 7.9 6.5–9.7ROR 8.2 · χ² 533 / p 4e-118 | 7.7 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.8 | no trial data cached |
| Therapeutic product effect incomplete | 78 | 9.0 7.2–11.2ROR 9.2 · χ² 548 / p 2e-121 | 8.7 EB05 7.2 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 1.6 · 88% consumer | no trial data cached |
| Hallucination (hallucinations) | 76 | 8.3 6.6–10.3ROR 8.5 · χ² 479 / p 1e-106 | 8.0 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 · 71% consumer | no trial data cached |
| Intentional overdose | 59 | 7.5 5.9–9.7ROR 7.7 · χ² 329 / p 7e-74 | 7.2 EB05 5.8 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 | no trial data cached |
| Middle insomnia | 55 | 24.2 18.6–31.4ROR 24.7 · χ² 1,195 / p 3e-262 | 23.9 EB05 19.1 · IC025 +3.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 3.4 · 93% consumer | no trial data cached |
| Brain fog | 44 | 24.6 18.4–33.0ROR 25.1 · χ² 972 / p 1e-213 | 24.3 EB05 18.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · 91% consumer | no trial data cached |
| No adverse event | 41 | 1.9 1.4–2.6ROR 1.9 · χ² 16 / p 3e-5 | 1.9 EB05 1.4 · IC025 +0.4 | Reporting / coding artifact | 78% consumer | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Brain fog — n=44, PRR 24.6
- Poisoning deliberate — n=25, PRR 21.9
- Restlessness — n=33, PRR 7.3
- Loss of personal independence in daily activities — n=37, PRR 6.3
- Night sweats — n=23, PRR 5.8
- Dysarthria — n=26, PRR 5.6
- Disturbance in attention — n=37, PRR 5.6
- Agitation — n=40, PRR 4.4
- Feeling abnormal — n=122, PRR 4.1
- Coma — n=24, PRR 4.1
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Daridorexant?
In FDA FAERS, the most frequently co-reported reaction terms for Daridorexant are insomnia, nightmare, somnolence, abnormal dreams, feeling abnormal, suicidal ideation. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Daridorexant have an FDA boxed warning?
No. The FDA label retrieved for Daridorexant has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Daridorexant causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 3a2d1503-b816-40c9-9fac-7e03c5a3bcef, effective 20260226; matched on
openfda.generic_name.exact:"DARIDOREXANT") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 84 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.