Drug · FAERS side-effect profile with label screen
Suvorexant side effects: what 12,887 FDA adverse event reports show
Brand names
Belsomra
openFDA label
Who reports
12,887 reports · 34% serious · 696 with death outcome · 60% female
openFDA FAERS counts, all years, deduplication not applied
Used for
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 ).
FDA label, Indications and Usage
What it is
BELSOMRA tablets contain suvorexant, an orexin receptor antagonist. Suvorexant is described chemically as: [(7R)-4-(5-chloro-2-benzoxazolyl) hexahydro-7-methyl-1H-1,4-diazepin-1-yl][5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone
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 6Likely indication confounding 3Reporting / coding artifact 10Not 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.
- 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. 964 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 |
|---|---|---|---|---|---|---|
| Sleep paralysis | 232 | 306.9 267.0–352.8ROR 312.5 · χ² 59,127 / p <1e-300 | 252.4 EB05 226.3 · IC025 +7.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=29 · 83% consumer | no trial data cached |
| Abnormal sleep-related event | 38 | 48.0 34.8–66.3ROR 48.2 · χ² 1,653 / p <1e-300 | 45.7 EB05 34.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=9 · 77% consumer | no trial data cached |
| Product blister packaging issue | 28 | 45.5 31.3–66.2ROR 45.6 · χ² 1,143 / p 9e-251 | 43.1 EB05 31.3 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Cataplexy | 37 | 43.2 31.2–59.9ROR 43.4 · χ² 1,446 / p <1e-300 | 41.3 EB05 31.3 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=19 · 83% consumer | no trial data cached |
| Abnormal dreams | 602 | 36.0 33.3–39.0ROR 37.7 · χ² 20,027 / p <1e-300 | 35.2 EB05 32.9 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.9 · 85% consumer | no trial data cached |
| Somnambulism | 141 | 35.6 30.1–42.0ROR 35.9 · χ² 4,601 / p <1e-300 | 34.7 EB05 30.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=26 · 86% consumer | no trial data cached |
| Nightmare | 740 | 35.4 33.0–38.0ROR 37.5 · χ² 24,192 / p <1e-300 | 34.6 EB05 32.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 · 81% consumer | no trial data cached |
| Labelled drug-food interaction medication error | 10 | 32.9 17.6–61.6ROR 33.0 · χ² 273 / p 1e-61 | 30.6 EB05 17.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Hangover | 64 | 30.0 23.4–38.3ROR 30.1 · χ² 1,731 / p <1e-300 | 29.2 EB05 23.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=5 · 73% consumer | no trial data cached |
| Sleep-related eating disorder | 16 | 28.2 17.2–46.2ROR 28.2 · χ² 386 / p 3e-86 | 26.9 EB05 17.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Therapeutic response increased | 15 | 26.5 15.9–44.2ROR 26.6 · χ² 338 / p 9e-76 | 25.3 EB05 16.2 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious n=14 | no trial data cached |
| Pleurothotonus | 11 | 19.9 11.0–36.0ROR 19.9 · χ² 176 / p 2e-40 | 18.6 EB05 10.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Sleep terror | 50 | 19.6 14.8–25.8ROR 19.6 · χ² 852 / p 1e-187 | 19.2 EB05 15.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=11 · 74% consumer | no trial data cached |
| Poor quality sleep | 223 | 17.1 15.0–19.5ROR 17.4 · χ² 3,338 / p <1e-300 | 16.9 EB05 15.1 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.2 | no trial data cached |
| Terminal insomnia | 18 | 17.0 10.7–27.1ROR 17.1 · χ² 253 / p 2e-57 | 16.3 EB05 10.5 · IC025 +2.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=4 | no trial data cached |
| Contraindicated product prescribed | 17 | 16.7 10.4–26.9ROR 16.7 · χ² 233 / p 6e-53 | 15.9 EB05 10.1 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious n=5 | no trial data cached |
| Middle insomnia | 175 | 15.4 13.3–17.9ROR 15.6 · χ² 2,329 / p <1e-300 | 15.3 EB05 13.5 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 12.7 · 77% consumer | no trial data cached |
| Sleep talking | 15 | 14.4 8.7–23.9ROR 14.4 · χ² 172 / p 1e-39 | 13.3 EB05 7.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Initial insomnia | 89 | 14.3 11.6–17.6ROR 14.4 · χ² 1,080 / p 4e-237 | 14.1 EB05 11.8 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=18 | no trial data cached |
| Drug effect variable | 10 | 14.3 7.7–26.6ROR 14.3 · χ² 110 / p 6e-26 | 12.4 EB05 6.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Drug effect delayed | 36 | 12.8 9.2–17.8ROR 12.9 · χ² 378 / p 2e-84 | 12.4 EB05 9.1 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Physical deconditioning | 19 | 12.4 7.9–19.5ROR 12.4 · χ² 187 / p 7e-43 | 11.5 EB05 7.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Product packaging difficult to open | 18 | 11.9 7.5–19.0ROR 11.9 · χ² 168 / p 9e-39 | 10.8 EB05 6.8 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Product packaging quantity issue | 77 | 11.6 9.2–14.4ROR 11.6 · χ² 727 / p 2e-160 | 11.3 EB05 9.3 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious n=4 | no trial data cached |
| Narcolepsy | 11 | 9.5 5.3–17.2ROR 9.5 · χ² 75 / p 2e-18 | 7.6 EB05 4.3 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=10 | no trial data cached |
| Radiation pneumonitis | 11 | 8.4 4.6–15.2ROR 8.4 · χ² 64 / p 6e-16 | 6.6 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Therapeutic response delayed | 14 | 8.2 4.9–13.9ROR 8.2 · χ² 81 / p 1e-19 | 6.8 EB05 4.2 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Hallucination (hallucinations) | 374 | 8.2 7.4–9.0ROR 8.4 · χ² 2,337 / p <1e-300 | 8.1 EB05 7.4 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.4 · 76% consumer | no trial data cached |
| Tachyphrenia | 17 | 8.0 5.0–12.9ROR 8.0 · χ² 97 / p 3e-23 | 6.9 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Therapeutic product effect delayed | 22 | 8.0 5.2–12.1ROR 8.0 · χ² 127 / p 1e-29 | 7.0 EB05 4.8 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | 77% consumer | no trial data cached |
| Delirium | 167 | 7.9 6.8–9.2ROR 8.0 · χ² 995 / p 1e-218 | 7.7 EB05 6.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 | no trial data cached |
| Stupor | 15 | 7.6 4.6–12.6ROR 7.6 · χ² 79 / p 3e-19 | 6.4 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Drug effect incomplete | 152 | 6.7 5.7–7.9ROR 6.8 · χ² 735 / p 4e-162 | 6.6 EB05 5.8 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 | no trial data cached |
| Altered state of consciousness | 86 | 6.5 5.3–8.0ROR 6.6 · χ² 395 / p 4e-88 | 6.3 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Paradoxical drug reaction | 14 | 6.2 3.7–10.5ROR 6.2 · χ² 56 / p 4e-14 | 5.2 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Enuresis | 15 | 6.1 3.7–10.1ROR 6.1 · χ² 58 / p 1e-14 | 5.2 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Loss of therapeutic response | 11 | 5.9 3.3–10.7ROR 5.9 · χ² 40 / p 1e-10 | 4.9 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Somnolence (drowsiness) | 731 | 5.9 5.5–6.4ROR 6.2 · χ² 3,012 / p <1e-300 | 5.9 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Femoral neck fracture | 18 | 5.7 3.6–9.1ROR 5.7 · χ² 65 / p 3e-16 | 5.0 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Depressive symptom | 12 | 5.6 3.2–9.8ROR 5.6 · χ² 40 / p 1e-10 | 4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=12 | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 3,030 | 3.8 3.6–3.9ROR 4.6 · χ² 6,504 / p <1e-300 | 3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 1.2 | no trial data cached |
| Nightmare | 740 | 35.4 33.0–38.0ROR 37.5 · χ² 24,192 / p <1e-300 | 34.6 EB05 32.6 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 · 81% consumer | no trial data cached |
| Somnolence (drowsiness) | 731 | 5.9 5.5–6.4ROR 6.2 · χ² 3,012 / p <1e-300 | 5.9 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Insomnia (trouble sleeping) | 680 | 4.2 3.9–4.5ROR 4.3 · χ² 1,643 / p <1e-300 | 4.1 EB05 3.9 · IC025 +1.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.9 | no trial data cached |
| Abnormal dreams | 602 | 36.0 33.3–39.0ROR 37.7 · χ² 20,027 / p <1e-300 | 35.2 EB05 32.9 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.9 · 85% consumer | no trial data cached |
| Headache | 545 | 1.4 1.3–1.5ROR 1.4 · χ² 68 / p 7e-17 | 1.4 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.2 | no trial data cached |
| Feeling abnormal | 489 | 3.3 3.0–3.6ROR 3.4 · χ² 794 / p 4e-175 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 · 75% consumer | no trial data cached |
| Nausea | 387 | 0.8 0.7–0.9ROR 0.8 · χ² 20 / p 3e-6 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.2 | no trial data cached |
| Hallucination (hallucinations) | 374 | 8.2 7.4–9.0ROR 8.4 · χ² 2,337 / p <1e-300 | 8.1 EB05 7.4 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.4 · 76% consumer | no trial data cached |
| No adverse event | 372 | 3.4 3.1–3.8ROR 3.5 · χ² 638 / p 5e-141 | 3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 | no trial data cached |
| Fatigue (tiredness) | 360 | 0.8 0.7–0.8ROR 0.7 · χ² 30 / p 2e-8 | 0.8 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 0.7 | no trial data cached |
| Dizziness | 334 | 1.1 1.0–1.2ROR 1.1 · χ² 3 / p 0.056 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Anxiety | 312 | 1.8 1.6–2.0ROR 1.8 · χ² 107 / p 2e-25 | 1.8 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Fall | 269 | 1.3 1.2–1.5ROR 1.3 · χ² 20 / p 3e-6 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Off label use (used outside approved label) | 266 | 0.5 0.4–0.6ROR 0.5 · χ² 139 / p 2e-32 | 0.5 EB05 0.5 · IC025 -1.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.2 | 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.
- Abnormal sleep-related event — n=38, PRR 48.0
- Somnambulism — n=141, PRR 35.6
- Nightmare — n=740, PRR 35.4
- Hangover — n=64, PRR 30.0
- Sleep terror — n=50, PRR 19.6
- Delirium — n=167, PRR 7.9
- Altered state of consciousness — n=86, PRR 6.5
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 Suvorexant?
In FDA FAERS, the most frequently co-reported reaction terms for Suvorexant are nightmare, somnolence, insomnia, abnormal dreams, headache, feeling abnormal. 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 Suvorexant have an FDA boxed warning?
No. The FDA label retrieved for Suvorexant has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Suvorexant 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 e5b72731-1acb-45b7-9c13-290ad12d3951, effective 20250310; matched on
openfda.generic_name.exact:"SUVOREXANT") - 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, 1,004 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.