suvorexant Side Effects
Also known as: Belsomra
Analysis of 12,687 adverse event reports submitted to the FDA from 2014 to 2025.
Total Reports
12,687
Death-Related
686
5.4% of reports
Hospitalizations
1,975
15.6% of reports
Top Indication
Insomnia
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 686 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 120 |
| COMPLETED SUICIDE | 83 |
| PNEUMONIA | 50 |
| INTERSTITIAL LUNG DISEASE | 43 |
| TOXICITY TO VARIOUS AGENTS | 43 |
| OFF LABEL USE | 32 |
| CARDIAC FAILURE | 31 |
| MALIGNANT NEOPLASM PROGRESSION | 29 |
| DECREASED APPETITE | 25 |
| DIARRHOEA | 25 |
| OVERDOSE | 25 |
| PNEUMONIA ASPIRATION | 25 |
| PYREXIA | 25 |
| ANAEMIA | 24 |
| SEPSIS | 23 |
| SOMNOLENCE | 23 |
| CARDIAC ARREST | 20 |
| DELIRIUM | 20 |
| CARDIO-RESPIRATORY ARREST | 18 |
| HEPATIC FUNCTION ABNORMAL | 18 |
Reactions in Hospitalization Reports
Top reactions in 1,975 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| FALL | 124 |
| PYREXIA | 110 |
| PNEUMONIA | 109 |
| NAUSEA | 95 |
| SOMNOLENCE | 92 |
| OFF LABEL USE | 91 |
| DECREASED APPETITE | 85 |
| DIARRHOEA | 78 |
| MALAISE | 72 |
| INSOMNIA | 68 |
| OVERDOSE | 64 |
| ANAEMIA | 63 |
| VOMITING | 63 |
| DIZZINESS | 59 |
| INTERSTITIAL LUNG DISEASE | 59 |
| INTENTIONAL OVERDOSE | 58 |
| DELIRIUM | 57 |
| DRUG INEFFECTIVE | 57 |
| HEPATIC FUNCTION ABNORMAL | 57 |
| ADVERSE EVENT | 54 |
Nearby — Related Medications
What the FAERS Data Reveals About suvorexant Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 12,687 voluntary reports linked to suvorexant and its brand equivalents (Belsomra), spanning 2014 through 2025. Of those, 686 (5.4%) listed death as an outcome and 1,975 (15.6%) involved hospitalization. The most common indication reported alongside adverse events was Insomnia.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 60% were female and 39% male; age distribution skews toward 45-64, with 2,033 reports in that bracket. The single most reported reaction is drug ineffective with 2,994 submissions, followed by nightmare and somnolence.
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.