Physiologically Based and Population Pharmacokinetic Modeling of Midazolam in Children With Obesity Using Real-World Data

Clinical and Translational Science, May 2025

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McCann S, Helfer VE, Balevic SJ, Muller WJ, van den Anker JN, Al-Uzri A, Meyer ML, Anderson SG, Turdalieva S, Edginton AN, Gonzalez D; Best Pharmaceuticals for Children Act Pediatric Trials Network Steering Committee.

Midazolam has been used as a sedative for hospitalized children on- and off-label; however, factors affecting interindividual variability (IIV) in observed clearance for this population are not fully understood and can result in extreme under- or overexposure. Obesity has been described as a significant influence on midazolam in adolescents, which could potentially alter drug exposure. The goal of this study was to use two modeling strategies to evaluate dose-exposure of midazolam in children with and without obesity.