{"id":"temazepam","brandName":"Restoril","genericName":"temazepam","companyId":"mallinckrodt","companyName":"Mallinckrodt","phase":"marketed","status":"active","modality":"","aliases":[],"developmentCodes":[],"firstApprovalDate":null,"firstApprovalCountry":null,"aiSummary":"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.","enrichmentLevel":3,"visitCount":0,"mechanism":{"target":"Nuclear receptor subfamily 1 group I member 3, GABA-A receptor alpha-1/beta-2/gamma-2","drugClass":"Benzodiazepine [EPC]"},"administration":{"route":"Oral"},"safety":{"boxedWarnings":["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 )."],"safetySignals":[{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"2803 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"2413 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"2402 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"2272 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"2235 reports"},{"date":"","signal":"TOXICITY TO VARIOUS AGENTS","source":"FDA FAERS","actionTaken":"2129 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"1789 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"1757 reports"},{"date":"","signal":"INSOMNIA","source":"FDA FAERS","actionTaken":"1670 reports"},{"date":"","signal":"DEATH","source":"FDA 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Follow patients for signs and symptoms of respiratory depression and sedation ( see WARNINGS","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:29:45.118597+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:30:00.879150+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: GABA-A receptor; anion channel positive allosteric modulator","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:30:00.417232+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL967/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:30:00.060828+00:00"},"safety.commonSideEffects":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"ADVERSE REACTIONS During controlled clinical studies in which 1076 patients received temazepam at bedtime, the drug was well tolerated. 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