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

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.