Conditions: Insomnia Attention Deficit Hyperactivity Disorder
Keywords: Hypnotic Eszopiclone Attention Deficit/Hyperactivity Disorder Insomnia Children Adolescent Polysomnography Actigraphy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 486
Healthy volunteers: no

Brief summary:
A multi center, randomized study to evaluate the efficacy and safety of eszopiclone compared to placebo in children (6-11 years of age, inclusive) and adolescents (12-17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.

Detailed description:
This is a multi center, randomized, double blind, placebo controlled, fixed dose study of eszopiclone in pediatric subjects 6-17 years of age, inclusive, with ADHD associated insomnia. Subjects will be randomized at approximately 1:1:1 to either low dose oral eszopiclone (1 mg for children ages 6-11 years, 2 mg for adolescents ages 12-17 years), high dose oral eszopiclone (2 mg for children ages 6-11 years, 3 mg for adolescents ages 12-17 years) or placebo. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Arms:
arm 1: 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years arm 2: 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years arm 3: Placebo 6-17 years

Interventions: intervention 1: eszopiclone intervention 2: eszopiclone intervention 3: Placebo
Intervention descriptions: intervention 1: 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years intervention 2: 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years intervention 3: 1 tablet per day for 12 weeks

Protocol document: