Safety and efficacy of remimazolam in critical illness.

Sedation is essential in intensive care units (ICUs) for invasive procedures and mechanical ventilation; however, commonly used agents are limited by hemodynamic instability, delayed recovery of consciousness, and delirium. Remimazolam, an ultra-short-acting benzodiazepine, introduced in 2020, is rapid metabolized by hepatic carboxylesterase 1 and enables predictable recovery after prolonged administration, suggesting potential advantages for sedation in critical illness despite limited ICU-specific evidence. A narrative review was conducted based on evidence derived from randomized controlled trials, meta-analyses, and observational studies, which indicated that remimazolam provides sedation efficacy comparable to that of conventional hypnotics across surgical anesthesia, procedural sedation, and ICU settings. Multiple meta-analyses have suggested that remimazolam is associated with favorable hemodynamic tolerance and does not increase the incidence of postoperative or ICU delirium compared with propofol or other sedative agents. Delirium risk appears to be more strongly influenced by patient severity, surgical characteristics, and sedation depth than by hypnotic choice alone, although the heterogeneity across studies may partly reflect differences in delirium diagnostic tools. In ICU patients requiring mechanical ventilation, remimazolam demonstrated safety and efficacy comparable to those of propofol or midazolam, with acceptable hemodynamic stability and no consistent signs of increased mortality. Several studies have also suggested that the predictable recovery profile associated with flumazenil may facilitate ventilator weaning or recovery of consciousness, although the interpretation of recovery outcomes requires caution, particularly in studies involving routine flumazenil administration. Pharmacokinetic data in ICU populations remain limited but suggest preserved dose linearity with reduced clearance in patients with severe hepatic dysfunction. Remimazolam may be a promising sedative option for critically ill patients, offering a predictable recovery and generally favorable hemodynamic profiles. However, its optimal role in ICU sedation requires confirmation through high-quality international multicenter studies, particularly regarding prolonged mechanical ventilation, neurocognitive outcomes, and cost-effectiveness.