lemborexant Side Effects
Also known as: Dayvigo
Analysis of 2,425 adverse event reports submitted to the FDA from 2015 to 2025.
Total Reports
2,425
Death-Related
267
11.0% of reports
Hospitalizations
1,064
43.9% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 267 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 32 |
| PNEUMONIA | 22 |
| INTERSTITIAL LUNG DISEASE | 20 |
| DECREASED APPETITE | 17 |
| PNEUMONIA ASPIRATION | 17 |
| CYTOKINE RELEASE SYNDROME | 15 |
| PYREXIA | 15 |
| COMPLETED SUICIDE | 12 |
| FALL | 12 |
| HEPATIC FUNCTION ABNORMAL | 11 |
| NAUSEA | 11 |
| OFF LABEL USE | 11 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 10 |
| PLEURAL EFFUSION | 10 |
| CARDIAC FAILURE | 9 |
| MALIGNANT NEOPLASM PROGRESSION | 9 |
| SEPSIS | 9 |
| CEREBRAL INFARCTION | 8 |
| DIARRHOEA | 8 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 8 |
Reactions in Hospitalization Reports
Top reactions in 1,064 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| SUICIDE ATTEMPT | 120 |
| CONDITION AGGRAVATED | 105 |
| DRUG INEFFECTIVE | 104 |
| SUICIDAL IDEATION | 101 |
| OFF LABEL USE | 91 |
| ADVERSE DRUG REACTION | 58 |
| FALL | 53 |
| PYREXIA | 49 |
| ALTERED STATE OF CONSCIOUSNESS | 47 |
| PNEUMONIA | 44 |
| DECREASED APPETITE | 41 |
| INTENTIONAL OVERDOSE | 41 |
| INTERSTITIAL LUNG DISEASE | 41 |
| SOMNOLENCE | 39 |
| MALAISE | 36 |
| OVERDOSE | 36 |
| DIZZINESS | 34 |
| HEPATIC FUNCTION ABNORMAL | 33 |
| DIARRHOEA | 32 |
| UNDERDOSE | 31 |
Nearby — Related Medications
What the FAERS Data Reveals About lemborexant Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 2,425 voluntary reports linked to lemborexant and its brand equivalents (Dayvigo), spanning 2015 through 2025. Of those, 267 (11.0%) listed death as an outcome and 1,064 (43.9%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 56% were female and 44% male; age distribution skews toward 65-74, with 474 reports in that bracket. The single most reported reaction is drug ineffective with 286 submissions, followed by off label use and suicide attempt.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.