Last reviewed 2026-04-20 · How we verify

Prosom (ESTAZOLAM)

Prosom (Estazolam) is a benzodiazepine medication originally developed by Abbott and currently owned by the same company. It targets the GABA-A receptor alpha-1/beta-2/gamma-2 subunits to produce its therapeutic effects. Approved by the FDA in 1990 for the treatment of severe insomnia, Prosom is a small molecule with a half-life of 18.4 hours and bioavailability of 93%. The medication is now off-patent, with multiple generic manufacturers available. Key safety considerations include its potential for dependence and abuse.

At a glance

Approved indications

• Severe 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 (see WARNINGS ). 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 Estazolam, 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 Estazolam and throughout treatment, assess each patient's risk for abuse, misuse, and addiction (see WARNINGS ). The continued use of benzodiazepines, including Estazolam, 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 Estazolam 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 Estazolam or reduce the dosage (see DOSAGE AND ADMINISTRATION and WARNINGS ).

Common side effects

• Somnolence
• Headache
• Asthenia
• Malaise
• Nausea
• Dizziness
• Hypokinesia
• Lower extremity pain
• Back pain
• Body pain
• Abdominal pain
• Chest pain

Drug interactions

• fluconazole
• fluvoxamine
• isoniazid
• itraconazole
• ketoconazole
• nefazodone
• posaconazole
• ritonavir
• sodium oxybate
• voriconazole

Key clinical trials

• Sunitinib or Cediranib for Alveolar Soft Part Sarcoma (PHASE2)
• Compound Ciwujia Granules in the Treatment of Insomnia (PHASE4)
• Efficacy of Auricular Pressure Beans with Electroacupuncture and Estazolam Treating Insomnia Caused by Cancer (PHASE3)
• Treatment of Chronic Insomnia According to Yin Yang Theory and Its Correlation With Circadian Rhythm (NA)
• A Randomized Controlled Trial of Auricular Acupressure in Treating Estazolam-dependent Insomnia (NA)
• "Chou's Tiaoshen" Acupoints for Short-term Insomnia. (NA)
• Effects of Dexmedetomidine on Cognitive Outcome and Brain Injury Markers (NA)
• Observation on the Effect of Auricular Acupoint Pressing on Insomnia and Adverse Events in MHD (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:

• Prosom CI brief — competitive landscape report
• Prosom updates RSS · CI watch RSS
• Abbott portfolio CI