Drug side effects
suvorexant Side Effects
The reactions most often reported to the FDA for suvorexant (also sold as Belsomra), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 12,687
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2014 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of suvorexant come from 12,687 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 12,687 reports to the FDA Adverse Event Reporting System (FAERS) for suvorexant (Belsomra): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
12,687
Reports Mentioning Death
686
5.4% of reports — not proof the medicine caused the death
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 |
| 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 |
| 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 |
| 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 nightmare with 736 submissions, followed by somnolence and insomnia.
How to read these numbers
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.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to suvorexant's 12,687.
Read our methodology - how this data is sourced, computed, and verified.