Intervention: Zopiclone
Trial phase: Phase 3
ATC code: N05CF01 | N05CF04
SMILES: CN1CCN(C(=O)OC2c3nccnc3C(=O)N2c2ccc(Cl)cn2)CC1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 159
Group description: 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
Eligibility criteria:
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.