Efficacy, Safety, and Tolerability of Ambien (Zolpidem) in the Treatment of Children Ages 6 to 17 With Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia

Inclusion Criteria:

• Male or female between the ages of 6 and 17 years, inclusive

• Children with diagnosed ADHD (as defined by the Diagnostic and Statistical Manual ofMental Disorders, 4th Edition, Text Revision [DSM-IV-TR] criteria)

• Complaint of childhood insomnia as defined by repeated difficulty with sleepinitiation or consolidation that occurs despite adequate age, appropriate time, andopportunity for sleep

• The sleep disturbance must not be attributable to either the direct physiologic effectof drug abuse or misuse of a prescribed medication.

• Subjects should be stabilized on all long-term therapy, including treatment of ADHD,for at least one month prior to study entry.

• Subjects, if females of childbearing potential (as determined by the initiation ofmenses), must have confirmed negative pregnancy test prior to randomization and beusing a recognized effective method of birth control (oral, implant, depot ortransdermal oestroprogestatives, intrauterine device, double-barrier with spermicide).Abstinence is an acceptable method of birth control for this study.

Exclusion Criteria:

• Mental retardation

• Autistic spectrum disorder

• A history of sleep apnea

• A history of bipolar disorder, conduct disorder, major depression, or generalizedanxiety disorder (not obsessive compulsive disorder), as determined by clinicalinterview and DSM-IV-TR criteria

• Current history of substance abuse/dependence

• Known hypersensitivity to zolpidem or previous adverse experience with zolpidem

• Pregnant or breast-feeding

• Current use of hypnotics, antihistamines, melatonin, herbal products, or other sleepaids