Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated Insomnia

Exclusion Criteria

• •Subject with weight \<10th percentile for age and gender
• •Subject has any clinically significant or unstable medical abnormality/illness
• •Subject has a documented history of Bipolar I or II Disorder, major depression, conduct disorder, generalized anxiety disorder (other than obsessive-compulsive disorder) or any history of psychosis, as determined by medical or psychiatric history or as determined by clinical interview using the MINI-Kid at Visit 1.
• •Subject has periodic limb movement \>5 times per hour, as demonstrated on PSG.
• •Subject has sleep disordered breathing, as demonstrated on PSG.
• •Subject has another primary sleep disorder (or secondary sleep disorder that is causing clinical impairment 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, lactating or planning to become pregnant.
• •Subject is taking any psychotropic or disallowed medications,
• •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
• •Subject has participated in any investigational study within 30 days prior to study entry or is currently participating in another clinical trial, except Study 190 246.