Temazepam is a benzodiazepine indicated for the short-term treatment of insomnia (generally 7 to 10 days). It is available as capsules for oral use. MedsAcross supplies Temazepam for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Restoril ® (temazepam) is 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 Restoril ® (temazepam) 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.
Source: US FDA prescribing information
While the recommended usual adult dose is 15 mg before retiring, 7.5 mg may be sufficient for some patients, and others may need 30 mg. In transient insomnia, a 7.5 mg dose may be sufficient to improve sleep latency. In elderly or debilitated patients, it is recommended that therapy be initiated with 7.5 mg until individual responses are determined. Discontinuation or Dosage Reduction of Restoril To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Restoril or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly.
Source: US FDA prescribing information
Boxed warning: Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including Restoril, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone.
Source: US FDA prescribing information
During controlled clinical studies in which 1076 patients received Restoril at bedtime, the drug was well tolerated. Side effects were usually mild and transient. Adverse reactions occurring in 1% or more of patients are presented in the following table: Restoril % Incidence (n=1076) Placebo % Incidence (n=783) Drowsiness 9.1
Source: US FDA prescribing information
The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation. The benzodiazepines, including temazepam, produce additive CNS-depressant effects when co-administered with other CNS depressants such as alcohol, barbiturates, antipsychotics, sedative/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative antihistamines, anticonvulsants, and anesthetics.
Source: US FDA prescribing information
Store at 20° to 25°C (68° to 77°F). © 2026 Par Health, Inc. or one of its affiliates.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
8 presentations of Temazepam, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Temazepam 15 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Temazepam 30 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Temazepam 7.5 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Temazepam 22.5 mg capsuleOralGeneric name | — | US FDA | Available on request |
| Restoril 7.5 mg capsuleOral | SpecGx | US FDA | Available on request |
| Restoril 15 mg capsuleOral | SpecGx | US FDA | Available on request |
| Restoril 22.5 mg capsuleOral | SpecGx | US FDA | Available on request |
| Restoril 30 mg capsuleOral | SpecGx | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 27 February 1981 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Temazepam in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 8 presentations of Temazepam and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Temazepam, including Restoril.
Yes. The US FDA first approved Temazepam on 27 February 1981, according to Drugs@FDA.
No listed presentation of Temazepam is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Temazepam is classified under ATC code N05CD07 (Temazepam).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.