REMIMAZOLAM INJ

Clinical Criteria Summary

FDA approved for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.
Induction of general anesthesia is off-label; optimal dosing has not been established.

Procedural Sedation (FDA Approved):
Induction: Administer 5 mg IV over 1 minute for adult patients. For ASA III and IV patients, administer 2.5 to 5 mg IV over 1 minute based on general condition.
Maintenance: Administer 2.5 mg IV over 15 seconds as needed. At least 2 minutes must elapse before any supplemental dose. For ASA III and IV patients, administer 1.25 to 2.5 mg IV over 15 seconds with the same 2-minute interval requirement.
General Anesthesia (Off-Label):
Dosing varies across studies; includes IV bolus or infusion for induction.
Approved dosing in Japan and South Korea: Initial infusion of 6-12 mg/kg/h for induction, followed by 1 mg/kg/h for maintenance (maximum rate 2 mg/kg/h).
Study dosing ranges: Bolus 0.2-0.4 mg/kg; Infusion 6, 9, or 12 mg/kg/h for induction; Maintenance 1-2 mg/kg/h.

Time to loss of consciousness (LOC), depth of anesthesia during maintenance, and recovery from anesthesia are generally similar between remimazolam and propofol, though some differences favor propofol for time to LOC, depth of anesthesia (measured by BIS index 40-60), and recovery.
Use of BIS index target values (40-60) may not be reliable for measuring appropriate depth of anesthesia with remimazolam or other benzodiazepines.
Evidence does not support replacing propofol with remimazolam for maintenance of anesthesia.

Post-induction hypotension (PIH) and need for vasoactive medications are significantly lower with remimazolam compared to propofol in most studies.
Hemodynamic changes during anesthesia maintenance are not statistically different between groups.
Injection site pain is reported more frequently with propofol. Post-op delirium, PONV, dizziness, and respiratory depression show no consistent differences between remimazolam and propofol.
Risk of delayed emergence due to variable CES1 metabolism (affected by inter-ethnic variability, genetic polymorphisms, hepatic impairment, age, BMI, low albumin, flavonoids, fatty acids, alcohol).
Risk of re-sedation after reversal with flumazenil; flumazenil should be reserved for delayed emergence or awakening. Initial dose 0.2 mg recommended; monitor for two hours after reversal.
Post-induction hypotension is generally defined as MAP <60-65 mmHg, >30% change from baseline, and need for vasoactive medications.

Contraindicated in patients with known hypersensitivity to Dextran 40 or products containing Dextran 40.
Several perioperative medications/fluids are incompatible with remimazolam, resulting in precipitation; consult product labeling for compatible fluids.
Use caution in elderly, frail, patients with multiple co-morbidities, shock states, at risk for cardiopulmonary collapse, or ASA III-IV status due to vulnerability to post-induction hypotension (though remimazolam may reduce this risk).

May offer an advantage over propofol for induction of anesthesia in patients vulnerable to post-induction hypotension (e.g., elderly, frail, multiple co-morbidities, shock states, at risk for cardiopulmonary collapse, ASA III-IV).
Should not be used for maintenance of anesthesia or ICU sedation based on current evidence.
Off-label use for induction of general anesthesia requires consideration of reduced post-induction hypotension risk and potential complications.

Download CFU PDF