Conditions: Insomnia Attention Deficit Hyperactivity Disorder
Keywords: Hypnotic Eszopiclone Attention Deficit Hyperactivity Disorder Insomnia Children Adolescent
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 304
Healthy volunteers: no

Brief summary:
A multicenter study to evaluate the safety of eszopiclone 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, open label, long term safety study in pediatric subjects 6 through 17 years of age, inclusive, with a diagnosis of ADHD associated insomnia. Subjects who complete Study 190 246 (Rollover subjects) and meet the study enrollment criteria will be allowed to participate in this long term safety study. Additionally, Treatment naïve subjects will be enrolled in this long term safety study in order to meet the overall subject enrollment objective of obtaining 100 subjects with 12 months of treatment. 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: None

Interventions: intervention 1: eszopiclone intervention 2: eszopiclone
Intervention descriptions: intervention 1: One 2 mg tablet per day for 12 months intervention 2: one 3mg tablet per day for 12 months

Protocol document: