Last reviewed 2026-04-20 · How we verify

Romazicon (FLUMAZENIL)

Romazicon (flumazenil) is a benzodiazepine antagonist developed by Hoffmann La Roche, targeting the gamma-aminobutyric acid receptor subunit alpha-5. It is a small molecule modality, FDA-approved in 1991 for treating benzodiazepine-induced sedation, benzodiazepine-maintained anesthesia, and benzodiazepine toxicity. Romazicon is off-patent, with eight generic manufacturers available. Key safety considerations include its short half-life of 0.78 hours and limited bioavailability of 16%. As an off-patent medication, Romazicon is widely available in the market.

At a glance

Approved indications

• Benzodiazepine Induced Sedation
• Benzodiazepine Maintained Anesthesia
• Benzodiazepine Toxicity

Common side effects

• Vomiting
• Dizziness
• Convulsions
• Headache
• Abnormal vision
• Injection site pain
• Increased sweating
• Fatigue
• Nausea
• Agitation
• Emotional lability
• Paresthesia

Key clinical trials

• Remimazolam TIVA-Flumazenil Antagonism in Short-duration ENT Surgeries
• The Effect of Reversal of Remimazolam Sedation With Flumazenil on Cognitive Function in Patients Undergoing Hip Arthroplasty Under Spinal Anesthesia (PHASE4)
• Comparison of Emergence Agitation Between Remimazolam With Flumazenil and Propofol-based Total Intravenous Anesthesia in Patients Undergoing Nasal Surgery (NA)
• Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam (NA)
• Effects of Music During Atrial Fibrillation Ablation Under Conscious Sedation (NA)
• Total Intravenous Anesthesia for Rigid Bronchoscopy Using Remimazolam (NA)
• PET with [18F]Flumazenil As an Index of Neurodegeneration in MS (NA)
• Sleep/Wake State Assessment with Non-invasive Earbuds (NA)

Primary sources

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