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A Pharmacokinetic and Safety Evaluation of Single Oral Doses of Eszopiclone in Pediatric Subjects from 6 to 17 Years of Age with Attention Deficit Hyperactivity Disorder and Insomnia

A Pharmacokinetic and Safety Evaluation of Single Oral Doses of Eszopiclone in Pediatric Subjects from 6 to 17 Years of Age with Attention Deficit Hyperactivity Disorder and Insomnia

Authors: Maier G, Lu Q, Blumer J, Robertson B, Zummo J, Ludwig E
Conference: American Academy of Child & Adolescent Psychiatry (AACAP)
Keywords: absorption lag time, ADHD, allometric function, cyclopyrrolone, CYP2E1, CYP3A4, dose selection, first-order absorption, first-order elimination, modeling and simulation, NONMEM, pediatrics, Phase 1, psychiatry, psychotherapeutic agents, Version V, WinNonlin
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Eszopiclone is a single-isomer, nonbenzodiazepine, cyclopyrrolone agent that has demonstrated efficacy with both polysomnography (PSG) and patient-reported measures in non-elderly adults with chronic primary…