Pharmacologic class (EPC) · 3 drug pages

gamma-Aminobutyric acid A receptor positive modulator: adverse event reports filed with FDA

35,609 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

35,609
reports across the class: 0.2% of all reports; 1,842
reports, 12 months to June 2026: 2,046 in the 12 months before; 80.3%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

gamma-Aminobutyric acid A receptor positive modulator is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 35,609 adverse event reports received by FDA, 0.2% of the database, from January 2004 to June 2026.

1,842 reports arrived in the 12 months to June 2026, down 10% from 2,046 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 80.3% of the class's reports are marked serious, 23% record death among the outcomes and 31.3% record hospitalisation, as reported.

Across the class the reactions recorded most often are completed suicide (12.1%), toxicity to various agents (10.2%) and drug ineffective (10%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
ZolpidemZolpidem tartrate	brand	18,405	956	90.7%	Completed suicide
AmbienZolpidem tartrate	brand	8,781	346	59.5%	Amnesia
Zolpidem tartrate	generic	8,423	540	79.4%	Completed suicide

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Completed suicidedeath by suicide12.1%4,307
Toxicity to various agentspoisoning or toxic effect of one or more substances10.2%3,632
Drug ineffectivethe medicine did not work as expected10%3,544
Drug abusemisuse of a medicine8.2%2,930
Amnesiamemory loss5.9%2,117
Somnolencedrowsiness5.6%1,983
Insomniadifficulty sleeping5.1%1,808
Intentional overdosea deliberate overdose5%1,785
Falla fall4.8%1,702
Drug dependencedependence on a medicine4.5%1,620
Overdosea dose above the recommended amount4.5%1,611
Suicide attempta suicide attempt4.5%1,610
Confusional stateconfusion4.2%1,483
Somnambulism4.1%1,444
Drug interactionan interaction between medicines3.7%1,334
Anxietyanxiety3%1,068
Loss of consciousnesspassing out2.9%1,030
Abnormal behaviourunusual behaviour2.9%1,026
Road traffic accidenta road accident2.7%979
Coma2.7%966
Deaththe patient died; cause not stated by this term2.7%956
Nauseafeeling sick2.6%924
Dizzinesslight-headedness or unsteadiness2.6%913
Hallucinationseeing or hearing things that are not there2.5%898
Cardio-respiratory arrestthe heart and breathing stopped2.4%865

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death23%8,187

Life-threatening7.1%2,518

Hospitalisation (initial or prolonged)31.3%11,150

Disability2.1%763

Congenital anomaly0.7%253

Other serious44.3%15,777

Not serious19.7%7,002

Patient age

Under 20.4%139

2 to 110.2%70

12 to 171.1%382

18 to 4422.3%7,934

45 to 6425.8%9,174

65 to 7410.4%3,693

75 and over9.8%3,473

Age not given30.2%10,744

Who reported

Physician29.2%10,412

Pharmacist12.6%4,491

Other health professional24.7%8,812

Lawyer1.2%436

Consumer or non-health professional27.4%9,750

Not given4.8%1,708

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about gamma-Aminobutyric acid A receptor positive modulator reports

Which drugs are in the gamma-Aminobutyric acid A receptor positive modulator class on this site?

Zolpidem, Ambien and Zolpidem tartrate. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

35,609 reports through June 2026, 1,842 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

completed suicide (12.1%), toxicity to various agents (10.2%), drug ineffective (10%), drug abuse (8.2%) and amnesia (5.9%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.