Remimazolam: A Review in Procedural Sedation

Remimazolam (Byfavo™) is a benzodiazepine sedative that is indicated for the induction and maintenance of procedural sedation in adults. Remimazolam was efficacious in three phase III trials in patients requiring endoscopies. Significantly higher procedure success rates (composite of the completion of the procedure, top-up doses of study drug within predefined limits and no requirement for rescue therapy) were observed with remimazolam than with placebo, with the majority of placebo recipients requiring rescue midazolam. Furthermore, remimazolam significantly reduced times to onset of sedation and recovery in comparison with placebo (plus rescue). Remimazolam is generally well tolerated, with hypotension and hypertension the most common adverse drug reactions. Higher doses of concomitant fentanyl with remimazolam may increase the incidence of adverse drug reactions and deep sedation events. However, no correlation was observed between depth of sedation and vital signs. In summary, remimazolam is a useful option for the induction and maintenance of procedural sedation. Although pharmacoeconomic analyses for remimazolam are not yet available, the rapid induction of sedation and short recovery times with remimazolam may be beneficial in improving patient throughput in clinics.