Drug · FAERS side-effect profile with label screen
Lemborexant side effects: what 2,742 FDA adverse event reports show
Brand names
Dayvigo
openFDA label
Who reports
2,742 reports · 77% serious · 326 with death outcome · 56% female
openFDA FAERS counts, all years, deduplication not applied
Used for
DAYVIGO is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance . DAYVIGO 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
DAYVIGO contains lemborexant, an orexin receptor antagonist.
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 5Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 6Lab value / disease marker 1Not in label — unassessed 26
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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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. 67 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 |
|---|---|---|---|---|---|---|
| Altered state of consciousness | 62 | 22.0 17.2–28.2ROR 22.5 · χ² 1,222 / p 5e-268 | 21.8 EB05 17.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 · 97% clinician | no trial data cached |
| Suicide attempt | 148 | 18.6 15.9–21.8ROR 19.7 · χ² 2,455 / p <1e-300 | 18.6 EB05 16.2 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.0 · ♀ 92% (drug 56%) | no trial data cached |
| Nightmare | 77 | 17.0 13.6–21.1ROR 17.4 · χ² 1,140 / p 4e-250 | 16.8 EB05 13.9 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 | no trial data cached |
| Pneumonia aspiration | 49 | 15.0 11.4–19.9ROR 15.3 · χ² 628 / p 7e-139 | 14.9 EB05 11.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 · ♀ 29% (drug 56%) · 94% clinician | no trial data cached |
| Cytokine release syndrome | 36 | 14.5 10.4–20.0ROR 14.6 · χ² 437 / p 2e-97 | 14.2 EB05 10.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 · ♀ 28% (drug 56%) · 100% clinician | no trial data cached |
| Hepatic function abnormal | 69 | 14.2 11.3–18.0ROR 14.6 · χ² 836 / p 3e-184 | 14.1 EB05 11.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 · 94% clinician | no trial data cached |
| Neuroleptic malignant syndrome | 20 | 12.9 8.3–19.9ROR 13.0 · χ² 207 / p 3e-47 | 12.1 EB05 7.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 · 100% clinician | no trial data cached |
| Middle insomnia | 29 | 11.9 8.3–17.1ROR 12.0 · χ² 279 / p 5e-63 | 11.4 EB05 8.0 · IC025 +2.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 4.7 · 79% consumer | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 15 | 11.3 6.8–18.7ROR 11.3 · χ² 130 / p 2e-30 | 9.9 EB05 5.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 130 | 10.8 9.2–12.8ROR 11.3 · χ² 1,156 / p 1e-253 | 10.7 EB05 9.2 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 · ♀ 93% (drug 56%) | no trial data cached |
| Interstitial lung disease | 65 | 10.3 8.1–13.1ROR 10.5 · χ² 536 / p 6e-119 | 10.0 EB05 8.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · 98% clinician | no trial data cached |
| Parkinsonism | 13 | 10.2 5.9–17.5ROR 10.2 · χ² 99 / p 1e-23 | 8.6 EB05 5.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Abnormal dreams | 37 | 10.2 7.4–14.0ROR 10.3 · χ² 297 / p 7e-67 | 9.6 EB05 7.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 · ♀ 35% (drug 56%) | no trial data cached |
| Drug eruption | 22 | 9.5 6.3–14.5ROR 9.6 · χ² 160 / p 6e-37 | 8.6 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Schizophrenia | 15 | 9.4 5.7–15.6ROR 9.5 · χ² 105 / p 7e-25 | 8.0 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Delirium | 41 | 9.1 6.7–12.3ROR 9.2 · χ² 286 / p 2e-64 | 8.5 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · ♀ 77% (drug 56%) · 98% clinician | no trial data cached |
| Hallucination, auditory | 18 | 8.6 5.5–13.7ROR 8.7 · χ² 114 / p 6e-27 | 7.5 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Cerebral infarction | 27 | 8.4 5.8–12.3ROR 8.5 · χ² 170 / p 4e-39 | 7.7 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · ♀ 35% (drug 56%) · 96% clinician | no trial data cached |
| Sedation | 28 | 8.2 5.7–11.9ROR 8.3 · χ² 170 / p 3e-39 | 7.5 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · 100% clinician | no trial data cached |
| Erythema multiforme | 10 | 8.2 4.4–15.2ROR 8.2 · χ² 56 / p 3e-14 | 6.4 EB05 3.6 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Intentional overdose | 61 | 7.3 5.7–9.4ROR 7.5 · χ² 327 / p 2e-73 | 7.0 EB05 5.6 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 5.6 · 98% clinician | no trial data cached |
| Therapy non-responder | 42 | 7.2 5.3–9.7ROR 7.3 · χ² 218 / p 1e-49 | 6.8 EB05 5.2 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 · ♀ 100% (drug 56%) · 95% clinician | no trial data cached |
| Disseminated intravascular coagulation | 13 | 7.0 4.1–12.1ROR 7.1 · χ² 61 / p 2e-15 | 5.8 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Covid-19 pneumonia | 10 | 6.4 3.5–11.9ROR 6.4 · χ² 41 / p 9e-11 | 5.1 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Delusion | 13 | 6.4 3.7–11.0ROR 6.4 · χ² 54 / p 9e-14 | 5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Depressed level of consciousness | 33 | 6.4 4.6–9.0ROR 6.5 · χ² 145 / p 1e-33 | 5.9 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 91% clinician | no trial data cached |
| Adrenal insufficiency | 10 | 6.4 3.4–11.9ROR 6.4 · χ² 40 / p 1e-10 | 5.1 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Adverse drug reaction | 72 | 6.2 4.9–7.7ROR 6.3 · χ² 307 / p 6e-69 | 5.9 EB05 4.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 12.9 · ♀ 98% (drug 56%) | no trial data cached |
| Poor quality sleep | 16 | 5.7 3.5–9.3ROR 5.7 · χ² 58 / p 2e-14 | 5.0 EB05 3.2 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 | no trial data cached |
| Mania | 12 | 5.6 3.2–9.8ROR 5.6 · χ² 41 / p 9e-11 | 4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Underdose | 53 | 5.5 4.2–7.2ROR 5.6 · χ² 193 / p 3e-44 | 5.3 EB05 4.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 15.8 · ♀ 81% (drug 56%) | no trial data cached |
| Drug level increased | 12 | 5.5 3.1–9.7ROR 5.6 · χ² 40 / p 1e-10 | 4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 | no trial data cached |
| Liver disorder | 32 | 5.5 3.9–7.8ROR 5.6 · χ² 114 / p 6e-27 | 5.1 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · ♀ 25% (drug 56%) · 94% clinician | no trial data cached |
| Prescribed underdose | 14 | 5.4 3.2–9.0ROR 5.4 · χ² 45 / p 8e-12 | 4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Somnolence (drowsiness) | 140 | 5.3 4.5–6.3ROR 5.6 · χ² 492 / p 3e-109 | 5.2 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | no trial data cached |
| Paralysis | 10 | 5.3 2.9–9.9ROR 5.3 · χ² 31 / p 1e-8 | 4.4 EB05 2.6 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Restlessness | 24 | 5.0 3.4–7.5ROR 5.0 · χ² 73 / p 6e-18 | 4.6 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · ♀ 33% (drug 56%) | no trial data cached |
| Feeding disorder | 13 | 5.0 2.9–8.6ROR 5.0 · χ² 38 / p 5e-10 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Neutrophil count decreased | 26 | 4.9 3.3–7.2ROR 4.9 · χ² 77 / p 8e-19 | 4.5 EB05 3.3 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 4.1 · 92% clinician | no trial data cached |
| Epilepsy | 19 | 4.8 3.0–7.4ROR 4.8 · χ² 53 / p 2e-13 | 4.3 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | 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 |
|---|---|---|---|---|---|---|
| Suicide attempt | 148 | 18.6 15.9–21.8ROR 19.7 · χ² 2,455 / p <1e-300 | 18.6 EB05 16.2 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.0 · ♀ 92% (drug 56%) | no trial data cached |
| Somnolence (drowsiness) | 140 | 5.3 4.5–6.3ROR 5.6 · χ² 492 / p 3e-109 | 5.2 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 130 | 10.8 9.2–12.8ROR 11.3 · χ² 1,156 / p 1e-253 | 10.7 EB05 9.2 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 · ♀ 93% (drug 56%) | no trial data cached |
| Nightmare | 77 | 17.0 13.6–21.1ROR 17.4 · χ² 1,140 / p 4e-250 | 16.8 EB05 13.9 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 | no trial data cached |
| Adverse drug reaction | 72 | 6.2 4.9–7.7ROR 6.3 · χ² 307 / p 6e-69 | 5.9 EB05 4.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 12.9 · ♀ 98% (drug 56%) | no trial data cached |
| Hepatic function abnormal | 69 | 14.2 11.3–18.0ROR 14.6 · χ² 836 / p 3e-184 | 14.1 EB05 11.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 · 94% clinician | no trial data cached |
| Interstitial lung disease | 65 | 10.3 8.1–13.1ROR 10.5 · χ² 536 / p 6e-119 | 10.0 EB05 8.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · 98% clinician | no trial data cached |
| Altered state of consciousness | 62 | 22.0 17.2–28.2ROR 22.5 · χ² 1,222 / p 5e-268 | 21.8 EB05 17.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 16.4 · 97% clinician | no trial data cached |
| Intentional overdose | 61 | 7.3 5.7–9.4ROR 7.5 · χ² 327 / p 2e-73 | 7.0 EB05 5.6 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 5.6 · 98% clinician | no trial data cached |
| Overdose | 53 | 1.9 1.4–2.4ROR 1.9 · χ² 21 / p 3e-6 | 1.9 EB05 1.5 · IC025 +0.4 | Reporting / coding artifact | serious PRR 1.7 · 92% clinician | no trial data cached |
| Inappropriate schedule of product administration | 53 | 2.3 1.8–3.0ROR 2.3 · χ² 38 / p 4e-10 | 2.3 EB05 1.8 · IC025 +0.7 | Reporting / coding artifact | serious PRR 3.6 | no trial data cached |
| Underdose | 53 | 5.5 4.2–7.2ROR 5.6 · χ² 193 / p 3e-44 | 5.3 EB05 4.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 15.8 · ♀ 81% (drug 56%) | no trial data cached |
| Pneumonia aspiration | 49 | 15.0 11.4–19.9ROR 15.3 · χ² 628 / p 7e-139 | 14.9 EB05 11.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 · ♀ 29% (drug 56%) · 94% clinician | no trial data cached |
| Renal impairment | 48 | 4.4 3.3–5.8ROR 4.4 · χ² 122 / p 9e-29 | 4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 · 94% clinician | no trial data cached |
| Hallucination (hallucinations) | 43 | 4.4 3.3–5.9ROR 4.4 · χ² 109 / p 7e-26 | 4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | 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.
- Altered state of consciousness — n=62, PRR 22.0
- Pneumonia aspiration — n=49, PRR 15.0
- Cytokine release syndrome — n=36, PRR 14.5
- Hepatic function abnormal — n=69, PRR 14.2
- Neuroleptic malignant syndrome — n=20, PRR 12.9
- Interstitial lung disease — n=65, PRR 10.3
- Drug eruption — n=22, PRR 9.5
- Delirium — n=41, PRR 9.1
- Cerebral infarction — n=27, PRR 8.4
- Sedation — n=28, PRR 8.2
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 Lemborexant?
In FDA FAERS, the most frequently co-reported reaction terms for Lemborexant are suicide attempt, somnolence, suicidal ideation, nightmare, hepatic function abnormal, interstitial lung disease. 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 Lemborexant have an FDA boxed warning?
No. The FDA label retrieved for Lemborexant has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Lemborexant 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 7074cb65-77b3-45d2-8e8d-da8dc0f70bfd, effective 20250224; matched on
openfda.generic_name.exact:"LEMBOREXANT") - 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, 107 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.