Last reviewed 2026-04-20 · How we verify

Restoril (temazepam)

Temazepam (Restoril), marketed by Mallinckrodt, is a benzodiazepine indicated for the short-term treatment of insomnia. A key strength is its well-established market presence, supported by a key composition patent expiring in 2028. The primary risk is the potential increase in generic competition following the patent expiry, which could erode market share and revenue.

At a glance

Approved indications

• Short-term treatment of insomnia

Boxed warnings

• WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS 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 ( see WARNINGS and PRECAUTIONS ). The use of benzodiazepines, including temazepam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing temazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction ( see WARNINGS ). The continued use of benzodiazepines, including temazepam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of temazepam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam or reduce the dosage ( see DOSAGE AND ADMINISTRATION and WARNINGS ).

Common side effects

• Drowsiness
• Headache
• Fatigue
• Nervousness
• Lethargy
• Dizziness
• Nausea
• Hangover
• Anxiety
• Depression
• Dry Mouth
• Diarrhea

Key clinical trials

• A Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Temazepam in HIV Seropositive Patients With Insomnia (Phase 4)
• Pharmacovigilance in Gerontopsychiatric Patients (Phase 3)
• Treatment of High-altitude Sleep Disturbance: A Double-blind Comparison of Temazepam Versus Acetazolamide. (NA)
• Phase I Study Characterizing Effects of Hallucinogens and Other Drugs on Mood and Performance (Phase 1)
• A Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of Doxepin and Temazepam in HIV Seropositive Patients With Insomnia. (Phase 4)
• A Randomised, Observer Blinded, Controlled Trial Of Femoral Nerve Block Versus Local Infiltration Analgesia for Post Operative Analgesia Following Total Knee Arthroplasty (NA)
• Effects of Temazepam on Dyspnea, Gas Exchange and Sleep Quality in Chronic Obstructive Pulmonary Disease. (Phase 3)
• A Randomised, Double-Blind, Placebo-Controlled Four-Way Cross-Over Trial to Study the Effects of Prolonged-Release Melatonin, Temazepam and Zolpidem on the Spectral Composition of the EEG During Noctu (Phase 1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Restoril CI brief — competitive landscape report
• Restoril updates RSS · CI watch RSS
• Mallinckrodt portfolio CI