Temazepam
Benzodiazepine Derivatives
Sold as RESTORIL
- Drug class
- Benzodiazepine Derivatives
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 28
- FDA reports (12 mo)
- 881
Overview
Plain-language summary, compiled from the cited regulatory records
Temazepam is a medication belonging to the drug class of benzodiazepine derivatives [1]. It is approved for the short-term treatment of insomnia, typically for 7 to 10 days [1]. Clinical trials supporting its effectiveness for insomnia lasted for two weeks, with the final assessment of sleep latency conducted at the end of the treatment period [1].
In the past 12 months, there have been 881 adverse event reports associated with temazepam [2]. The most frequently reported events include off-label use, headache, pain, hypertension, and overdose [2]. Temazepam is available under various brand names [1].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 18 | May 29, 2026 |
| CA Canada | Health Canada | 6 | March 5, 2026 |
| US United States | FDA | 4 | January 9, 2025 |
GBUnited Kingdom· MHRA
18 products
Uses
Short-term management of insomnia. Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. For premedication prior to minor surgery or other related procedures.
How to take
CACanada· Health Canada
6 products
Uses
JAMP
Temazepam (temazepam capsules) is indicated for the symptomatic relief of transient and short-term insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings and/or early morning awakenings. The use of hypnotics should be restricted for insomnia where disturbed sleep results in impaired daytime functioning.
1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics: Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness.
Long-term use of JAMP Temazepam should be avoided in elderly patients. 1 Dosing considerations).
USUnited States· FDA
4 products
Uses
INDICATIONS & USAGE
Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days).
The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.
How to take
Drug interactions
Known interactions involving Temazepam. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 600. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL045690332 · revised May 22, 2026
- [2]Health Canada (DPD) · 02565803 · revised March 5, 2026
- [3]FDA DailyMed · 08183adb-af12-fc… · revised January 9, 2025 [PDF]
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.