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Human Safety and Pharmacokinetic Study of Intramuscular Midazolam Administered by Autoinjector

Midazolam in an autoinjector was evaluated in an open‐label dose escalation study involving 39 healthy participants. Safety and pharmacokinetic parameters were determined for doses ranging from 5 to 30 mg. No serious adverse events were noted during the study. Two participants (30 mg) experienced changes in their electrocardiogram (trigeminy and prolongation of QRS complex) that met the criteria for dose‐limiting adverse events. No significant respiratory depression was noted during the study. The midazolam doses studied exhibited a median tmax of 0.5 hours with a geometric mean terminal elimination half‐life value of 4.1 hours (range, 2.9–4.5 hours). The extent of systemic exposure, assessed by area under the curve (AUC) and maximum concentration (Cmax), tended to increase proportionally with increasing doses from 5 to 30 mg; however, for the male 30‐mg group, there was evidence of a larger than proportional increase in AUC.