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Diazepam is labeled for status epilepticus ( SE ) in children, but there are limited data characterizing its disposition in pediatric patients. We developed a population pharmacokinetic ( PK ) model of i.v. diazepam in children with  SE . We evaluated relationships between  PK  parameters and both safety and efficacy, and simulated exposures using dosing regimens from the product label and clinical practice. The model was developed using prospective data from a pediatric clinical trial comparing diazepam to lorazepam for treatment of  SE . Altogether, 87 patients aged ≥ 3 months to < 18 years contributed 162 diazepam concentrations. Diazepam  PK s were well characterized by a two‐compartment model scaled by body size. No significant or clinically important relationships were observed between diazepam  PK s and safety or efficacy. Simulations demonstrated that, compared with label dosing, the study dose (0.2 mg/kg i.v., maximum 8 mg) resulted in greater frequency in rapidly achieving the target therapeutic range of 200–600 ng/mL.

Population Pharmacokinetics and Exploratory Exposure‐Response Relationships of Diazepam in Children Treated for Status Epilepticus