Belsomra: adverse event reports filed with FDA

9,391

reports as suspect product

0.1% of all reports · about 805 a year

178

reports, 12 months to June 2026

198 in the 12 months before

17.9%

marked serious by the reporter

22% across the class

1.7%

record death among outcomes, as reported

158 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Belsomra reports recording the termmedian drug in orexin receptor antagonist

1. Drug ineffectivethe medicine did not work as expected30.7%2,882
2. Nightmarenightmares7.7%727
3. Somnolencedrowsiness6.6%621
4. Abnormal dreamsunusual dreams6.3%592
5. Insomniadifficulty sleeping5.7%535
6. Feeling abnormalfeeling odd or not right4.6%431
7. Headachehead pain4.5%426
8. No adverse eventno adverse event was reported3.8%356
9. Hallucinationseeing or hearing things that are not there3.6%336
10. Fatiguetiredness2.5%234
11. Sleep paralysis2.4%228
12. Dizzinesslight-headedness or unsteadiness2.4%225
13. Anxietyanxiety2.3%219
14. Poor quality sleep2.3%215
15. Wrong technique in product usage processthe product was used in the wrong way2.2%205
16. Product dose omission issuea dose was missed2.1%201
17. Adverse eventan unwanted medical event, type not specified2.1%198
18. Nauseafeeling sick2%192
19. Sleep disordera sleep problem1.9%182
20. Product use issuea problem in how the product was used1.8%172
21. Middle insomnia1.8%168
22. Drug effect incomplete1.5%144
23. Overdosea dose above the recommended amount1.5%144
24. Malaisegeneral feeling of being unwell1.4%133
25. Somnambulism1.4%129
26. Drug dose omissiona dose was missed1.2%113
27. Agitationrestlessness1.2%112
28. Palpitationsawareness of the heartbeat1.2%109
29. Diarrhoealoose or frequent stools1.2%108
30. Depressionlow mood1.1%106

Top 30 of 511 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 3 drugs in the orexin receptor antagonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 12,711 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 89.2% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 9,391 reports.

Drugs most often listed in the same reports

Other products listed in reports where Belsomra is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the orexin receptor antagonist class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Belsomra as a suspect or interacting product; reports listing it only as a concomitant medication (2,939) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.