Long Term Safety Study of Study Drug (Eszopiclone) in Children and Adolescents With ADHD -Associated Insomnia
Condition: Insomnia; Attention Deficit Hyperactivity Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders; Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: eszopiclone; eszopiclone
Intervention description: One 2 mg tablet per day for 12 months; one 3mg tablet per day for 12 months
Intervention MeSH terms: Eszopiclone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 304.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Hypnotic; Eszopiclone; Attention Deficit Hyperactivity Disorder; Insomnia; Children; Adolescent

Summary:

      A multicenter study to evaluate the safety of eszopiclone in children (6 11 years of age,
      inclusive) and adolescents (12 17 years of age, inclusive) with attention
      deficit/hyperactivity disorder (ADHD) associated insomnia.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria:

          -  Subject is male or female 6 17 years of age, inclusive, at the time of consent.

          -  Subject must have a diagnosis of ADHD as defined by DSM-IV criteria • The diagnosis
             for Rollover subjects will be taken from the Screening visit of Study 190 246.
             Treatment naïve subjects will have these assessments performed at the Screening visit.

          -  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 has either >30 minutes latency to persistent sleep (LPS) or >45 minutes wake
             time after sleep onset (WASO) demonstrated by PSG.

          -  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 at screening

          -  Subject must be in good general health.

          -  Subject must be able to swallow tablets.

          -  If subjects are currently taking medication for ADHD, they must be on a stable dose
             and regimen for at least one month, and preferably for at least 3 months 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 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.