Study Summary:
Pacific Institute for Medical Research is conducting a clinical research study for volunteers ages 6-17 years old diagnosed with ADHD-associated insomnia. The medication is Lunesta ( esopiclone). The study duration is up to 17 weeks, of which there are two sleep lab overnight visits (lab is located in the St. John’s hospital and parents are able to stay with their kids).
Qualified Participants Must:
• Be male or female 6 to 17 years of age, inclusive, at the time of consent
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Have a diagnosis of ADHD as defined by DSM-IV criteria
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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, despite adequate age appropriate time and opportunity for sleep
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Subject's Baseline PSG must reveal either ≥30 minutes latency to persistent sleep (LPS) or ≥45 minutes wake after sleep onset (WASO)
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Subject or subject's parent/legal guardian should have reported daytime functional impairment as a result of sleep problems
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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
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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)
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Be in general good health
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Be able to swallow tablets
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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
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Not have weight <10th percentile for age and gender
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Not have any clinically significant or unstable medical illness/abnormality
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Not have a documented history of Bipolar I or II Disorder, major depression, conduct disorder, generalized anxiety disorder or any history of psychosis
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Not have a periodic limb movement >5 times per hour, as demonstrated on Baseline PSG
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Not have sleep disordered breathing, as demonstrated on Baseline PSG
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Not have another primary sleep disorder or any other known or suspected medical or psychiatric condition that has affected or may affect sleep
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Not have a history of circadian rhythm disorder or will travel across ≥3 time zones more than once during the study
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Not have organic brain disease, or a history of febrile seizures
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Not, in the opinion of the investigator, be a suicidal or homicidal risk
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Not be a female subject who is pregnant or lactating
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Not be taking any psychotropic medication or disallowed medications for chronic treatment
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Not have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions
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Not have 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
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Not havea history of alcohol or substance abuse within 3 months of study participation
Qualified Participants May Receive:
Study medication, ECG, physical exams, and $35.00 per visit and $100.00 for the overnight visit compensation.