Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 20 mg lyophilized powder for reconstitution) |
Drug Class | Benzodiazepines |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.
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Summary
- Byfavo (remimazolam) is indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.
- This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
- Propofol vs. Remimazolam: In elderly patients undergoing gastrointestinal procedures, propofol demonstrated a significantly faster time to loss of consciousness and higher initial sedation success compared to remimazolam, despite remimazolam showing a superior safety profile.
- Remimazolam vs. Midazolam: Remimazolam was more effective than midazolam, leading to reduced need for additional doses and better procedural success in colonoscopy patients and general procedural sedation.
- Sedative Efficiency: Remimazolam exhibited higher sedative efficiency than placebo and midazolam but was less effective than propofol in endoscopic procedures.
- Remimazolam consistently exhibited a significantly lower incidence of adverse events, including respiratory depression, hypoxemia, bradycardia, dizziness, injection site pain, nausea, and hypotension, when compared to propofol across various studies.
- In comparisons with midazolam, remimazolam demonstrated comparable overall adverse event rates but showed improved cognitive recovery and reduced need for rescue medication, with specific adverse events being inconclusive.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Byfavo (remimazolam) Prescribing Information. | 2023 | Acacia Pharma, Inc., Indianapolis, IN |