Zolpidem tartrate: adverse event reports filed with FDA

8,423

reports as suspect product

0% of all reports · about 374 a year

540

reports, 12 months to June 2026

572 in the 12 months before

79.4%

marked serious by the reporter

80.3% across the class

23.5%

record death among outcomes, as reported

1,983 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 Zolpidem tartrate reports recording the termmedian drug in gamma-aminobutyric acid a receptor positive modulator

1. Completed suicidedeath by suicide12.8%1,079
2. Drug ineffectivethe medicine did not work as expected12.5%1,052
3. Drug abusemisuse of a medicine9.2%773
4. Toxicity to various agentspoisoning or toxic effect of one or more substances8.9%749
5. Intentional overdosea deliberate overdose6.8%571
6. Somnolencedrowsiness5.9%496
7. Insomniadifficulty sleeping5.5%463
8. Suicide attempta suicide attempt5.4%456
9. Overdosea dose above the recommended amount4.6%388
10. Deaththe patient died; cause not stated by this term4.3%359
11. Falla fall4.2%350
12. Drug dependencedependence on a medicine4.1%348
13. Cardio-respiratory arrestthe heart and breathing stopped3.9%331
14. Confusional stateconfusion3.9%331
15. Drug interactionan interaction between medicines3.5%296
16. Sopor3.2%268
17. Amnesiamemory loss3%256
18. Loss of consciousnesspassing out3%253
19. Dizzinesslight-headedness or unsteadiness2.8%239
20. Deliriumsudden confusion2.8%235
21. Anxietyanxiety2.7%225
22. Somnambulism2.7%225
23. Product substitution issuea problem after switching products2.6%223
24. Hypotensionlow blood pressure2.5%209
25. Vomitingbeing sick2.4%204
26. Intentional product misusedeliberate use not as intended2.4%202
27. Coma2.3%193
28. Nauseafeeling sick2.2%182
29. Hallucinationseeing or hearing things that are not there1.9%161
30. Intentional self-injury1.9%161

Top 30 of 1,071 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 gamma-aminobutyric acid a receptor positive modulator 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 35,609 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. 48.8% 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 8,423 reports.

Drugs most often listed in the same reports

Other products listed in reports where Zolpidem tartrate 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 gamma-aminobutyric acid a receptor positive modulator 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 Zolpidem tartrate as a suspect or interacting product; reports listing it only as a concomitant medication (16,426) 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.