Brand name · Temazepam
Restoril: adverse event reports filed with FDA
1,018 reports list it as a suspect or interacting product, 2004–2026. Class: Benzodiazepine. Also reported as Restoril /00393701/, Restoril /00054301/.
- 1,018
- reports as suspect product
- 0% of all reports · about 46 a year
- 66
- reports, 12 months to June 2026
- 130 in the 12 months before
- 79.8%
- marked serious by the reporter
- 88.1% across the class
- 22.2%
- record death among outcomes, as reported
- 226 reports · not verified by FDA
Between April 2004 and June 2026, 1,018 adverse event reports received by FDA list the brand name Restoril (temazepam) as a suspect or interacting product. Reports that mention it only as a concomitant medication (7,171) are left out of every figure here.
In the 12 months to June 2026, 66 reports listed it, down 49% from 130 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 46 reports a year and 0% of the 20,646,523 reports in the database, and 0.4% of the reports for the benzodiazepine class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are headache (36.3%), pain (36.1%) and hyperhidrosis (34.3%). A report can list several reactions, so shares add to more than 100%; 362 different terms appear across these reports. Headache is recorded in 36.3% of these reports, a larger share than in the median benzodiazepine drug (2.4%).
79.8% of the reports are marked serious by the reporter (88.1% across the class); 22.2% record death among the outcomes and 11.1% record hospitalisation, as reported. 39.5% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (26.1%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 Restoril reports recording the termmedian drug in benzodiazepine
- Headachehead pain36.3%370
- Painpain, site not specified36.1%367
- Hyperhidrosisexcessive sweating34.3%349
- Hepatic enzyme increasedraised liver enzymes33.8%344
- Immunodeficiency33.7%343
- Hypersensitivityan allergic-type reaction33.5%341
- Food allergy33.3%339
- Exposure during pregnancythe medicine was taken during pregnancy31.1%317
- Asthmaasthma30.5%310
- Upper respiratory tract infectiona cold or similar infection30.5%310
- Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease30.3%308
- Rash erythematousa red rash30.2%307
- Off label useused for a purpose or in a way not on the label27.2%277
- Overdosea dose above the recommended amount26.8%273
- Temperature regulation disorder26.6%271
- Drug hypersensitivityan allergic-type reaction to a medicine26.4%269
- Fluid retentionthe body holding extra fluid26.4%269
- Product use issuea problem in how the product was used25.2%257
- Hypertensionhigh blood pressure25%255
- Fatiguetiredness25%254
- Prescribed overdose24.6%250
- Back painback pain24.3%247
- Constipationconstipation24.2%246
- Infusion related reactiona reaction during or soon after an infusion23.9%243
- Joint swellinga swollen joint23.9%243
- Intentional product misusedeliberate use not as intended23.8%242
- Coeliac disease23.7%241
- Bursitis23.5%239
- Erythemaskin redness22.9%233
- Pyrexiafever21.5%219
Top 30 of 362 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 19 drugs in the benzodiazepine 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 244,289 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 49.7% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Insomnia | 96 | 9.4% |
| Sleep disorder | 49 | 4.8% |
| Pain | 8 | 0.8% |
| Depression | 6 | 0.6% |
| Anxiety | 4 | 0.4% |
| Back pain | 2 | 0.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,018 reports.
In context
| Measure | Restoril | Benzodiazepine | All reports |
|---|---|---|---|
| Reports as suspect product | 1,018 | 244,289 | 20,646,523 |
| Share of that pool | — | 0.4% | 0% |
| Reports, latest 12 months | 66 | — | 1,332,454 |
| Marked serious | 79.8% | 88.1% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 222 | 297 | 91 |
| Hospitalisation recorded, per 1,000 reports | 111 | 346 | 213 |
| Consumer-filed share | 33.1% | 21.3% | 45.8% |
| Top term, share of reports | Headache 36.3% | median 2.4% | 3% |
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 benzodiazepine class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Alprazolam | generic | 48,263 | 2,271 | 90.4% |
| Diazepam | generic | 40,060 | 2,762 | 94.8% |
| Clonazepam | generic | 37,432 | 2,530 | 86.7% |
| Lorazepam | generic | 33,307 | 2,010 | 90% |
| Xanax | brand | 17,444 | 520 | 78.2% |
| Midazolam | generic | 11,299 | 872 | 92.6% |
| Oxazepam | generic | 10,709 | 1,200 | 99.1% |
| Valium | brand | 9,650 | 477 | 84% |
| Clobazam | generic | 8,005 | 712 | 89.1% |
| Temazepam | generic | 7,422 | 308 | 90.7% |
| Klonopin | brand | 5,832 | 56 | 56.5% |
| Ativan | brand | 5,318 | 255 | 77.8% |
| Onfi | brand | 3,543 | 41 | 57.5% |
| Midazolam hydrochloride | generic | 1,731 | 125 | 88.6% |
| Triazolam | generic | 1,479 | 66 | 84.3% |
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.
Questions about Restoril reports
How many adverse event reports has FDA received for Restoril?
1,018 reports list Restoril as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 66 of them arrived in the latest 12 months. Another 7,171 list it only as a concomitant medication.
What reactions are recorded in Restoril reports?
headache (36.3%), pain (36.1%), hyperhidrosis (34.3%), hepatic enzyme increased (33.8%) and immunodeficiency (33.7%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Restoril was responsible.
How serious are the reports?
79.8% are marked serious by the reporter. Among the outcomes recorded, 22.2% of reports include death and 11.1% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (39.5%), consumer or non-health professional (33.1%) and physician (16.6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Restoril rising?
66 reports in the 12 months to June 2026, down 49% from 130 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Restoril was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Restoril?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. 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 report counts here when it lists Restoril as a suspect or interacting product; reports listing it only as a concomitant medication (7,171) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.