Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia

A Randomized, Placebo Controlled, Double Blind, Fixed Dose Study of the Efficacy and Safety of Eszopiclone in Children (6 to 11 Years) and Adolescents (12 to 17 Years) With Attention Deficit/Hyperactivity Disorder Associated Insomnia

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.

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.

Inclusion Criteria:

• Subject is male or female 6 to 17 years of age, inclusive, at the time of consent.
• Subject must have a diagnosis of ADHD as defined by DSM-IV criteria
• Subject must have documented ADHD associated insomnia, defined as the subject or subject's parent/legal guardian having reported repeated difficulty with sleep initiation (sleep latency >30 minutes) or consolidation, (wake time after sleep onset >45 minutes) despite adequate age appropriate time and opportunity for sleep.
• Subject's Baseline PSG must reveal either >30 minutes latency to persistent sleep (LPS) or >45 minutes wake after sleep onset (WASO).
• Subject or subject's parent/legal guardian should have reported daytime functional impairment as a result of sleep problems.
• Subject or subject's parent/legal guardian should have reported attempted and failed behavioral interventions for sleep problems, including a regular bedtime and rise time
• Subject's sleep disturbance must not be attributable to either the direct physiologic effect of a drug of abuse or misuse of a prescribed medication whether it is being used as intended or in an illicit manner.(Female subjects ≥8 years of age must have a negative serum pregnancy test)
• Subject must be in general good health
• Subject must be able to swallow tablets.
• If subject is currently taking medication for ADHD, they must be on a stable dose and regimen for a minimum of 1 month prior to the time of consent

Exclusion Criteria:

• Subject with weight <10th percentile for age and gender
• Subject has any clinically significant or unstable medical illness/abnormality or chronic disease.
• Subject has a documented history of Bipolar I or II Disorder, major depression, conduct disorder, generalized anxiety disorder or any history of psychosis.
• Subject has periodic limb movement >5 times per hour, as demonstrated on Baseline PSG.
• Subject has sleep disordered breathing, as demonstrated on Baseline PSG.
• Subject has another primary sleep disorder, a secondary sleep disorder, or any other known or suspected medical or psychiatric condition that has affected or may affect sleep
• Subject has a history of circadian rhythm disorder or will travel across ≥3 time zones more than once during the study.
• Subject has organic brain disease, or a history of febrile seizures.
• Subject is, in the opinion of the investigator, at suicidal or homicidal risk.
• Female subject who is pregnant or lactating or planning to become pregnant.
• Subject has taken any psychotropic medication without an appropriate washout period (≥5 half-lives) prior to randomization.
• Subject has a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.
• Subject has a history of allergic reaction or has a known or suspected sensitivity to racemic zopiclone, eszopiclone, or any substance that is contained in the formulation.
• Subject has a history of alcohol or substance abuse within 3 months of study participation.