Last reviewed 2026-04-20 · How we verify

Dalmane (FLURAZEPAM)

Dalmane (flurazepam) is a benzodiazepine medication originally developed by Roche and currently owned by Valeant Pharmaceuticals International. It targets the GABA-A receptor alpha-1/beta-2/gamma-2 subunits to produce its therapeutic effects. Dalmane is approved by the FDA for the treatment of insomnia and is available as a generic medication due to its off-patent status. As a benzodiazepine, Dalmane carries a risk of dependence and abuse, and its use should be carefully monitored. Despite its off-patent status, Dalmane remains a commercially viable medication.

At a glance

Approved indications

• 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 ( 5.1 ) and Drug Interactions ( 7.1 ) ]. The use of benzodiazepines, including flurazepam hydrochloride capsules, 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 flurazepam hydrochloride capsules, and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction [ see Warnings and Precautions ( 5.2 ) ]. The continued use of benzodiazepines, including flurazepam hydrochloride capsules, 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 flurazepam hydrochloride capsules 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 flurazepam hydrochloride capsules or reduce the dosage [ see Dosage and Administration ( 2.3 ) and Warnings and Precautions ( 5.3 ) ]. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS See full prescribing information for complete 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 ( 5.1 , 7.1 ). The use of benzodiazepines, including flurazepam hydrochloride capsules, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing flurazepam hydrochloride capsules and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction ( 5.2 ). Abrupt discontinuation or rapid dosage reduction of flurazepam hydrochloride capsules 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 flurazepam hydrochloride capsules or reduce the dosage ( 2.3 , 5.3 ).

Common side effects

• Dizziness
• Drowsiness
• Light-headedness
• Staggering
• Ataxia
• Falling
• Severe sedation
• Lethargy
• Disorientation
• Coma
• Headache
• Heartburn

Drug interactions

• ritonavir

Key clinical trials

• Sunitinib or Cediranib for Alveolar Soft Part Sarcoma (PHASE2)
• Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder (PHASE1)
• Pharmacovigilance in Gerontopsychiatric Patients (PHASE3)
• Effects of Discontinuation of Benzodiazepine-derivative Hypnotics on Cognitive and Motor Functions in Elderly Persons (PHASE4)

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:

• Dalmane CI brief — competitive landscape report
• Dalmane updates RSS · CI watch RSS