US BOXED WARNINGS :
-CONCOMITANT USE OF OPIOIDS: Concomitant use with opioids may result in profound sedation, respiratory depression, coma, and/or death. Use should be limited to patients for whom alternative treatment options are inadequate, and the dose and duration should be as low and short as possible. Patients should be monitored for respiratory depression and sedation.
-INTRAVENOUS USE: Intravenous use has been associated with respiratory depression and respiratory arrest, particularly when used for sedation in noncritical care settings. Death or hypoxic encephalopathy has resulted in some cases where this was not recognized promptly and treated effectively. Intravenous midazolam should only be used in settings that provide for continuous monitoring of respiratory and cardiac function. Immediate availability of age-appropriate resuscitative equipment and personnel trained in resuscitation should be assured. For deeply sedated patients, a dedicated individual, other than the practitioner performing the procedure, should monitor the patient throughout the procedure.
-USE IN ADULTS: The initial dose for sedation should not exceed mg in a normal, healthy adult. Lower doses are recommended in patients over 60 years, debilitated patients, and patients on concomitant narcotics or other CNS depressants. The initial dose and all subsequent doses should always be titrated slowly and administered over at least 2 minutes, with at least 2 minutes allowed to elapse to fully evaluate the sedative effect. The use of the 1 mg/mL formulation or dilution of the 1 mg/mL or 5 mg/mL formulation is recommended to facilitate slower injection.
-USE IN PEDIATRICS: Doses should be calculated on a mg/kg basis. Initial doses and all subsequent doses should be titrated slowly. The initial pediatric dose for sedation/anxiolysis/amnesia is age, procedure, and route dependent.
-USE IN NEONATES: Rapid injection is not recommended. Severe hypotension and seizures have been reported following rapid IV administration, particularly with concomitant use of fentanyl.
Safety and efficacy of oral syrup formulations have not been established in patients younger than 6 months.
Consult WARNINGS section for additional precautions.
US Controlled Substance: Schedule IV