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

Completed · Phase 3

Conditions studied: Attention Deficit Hyperactivity Disorder

In brief

There has been an increased interest in the association between ADHD and sleep disorders over the past years. A high incidence of sleep disturbance, ranging from 10% to 70%, has been identified in ADHD children regardless of whether or not they are receiving stimulant therapy. This study will assess the safety and efficacy of zolpidem in children with ADHD associated insomnia.

Key facts

Study ID

NCT00318448

Run by

Sanofi

People needed

201

Starts

2006-04-01

Expected to finish

2006-08-01

Last updated by the study team

2009-04-07

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female between the ages of 6 and 17 years, inclusive
• Children with diagnosed ADHD (as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision [DSM-IV-TR] criteria)
• Complaint of childhood insomnia as defined by repeated difficulty with sleep initiation or consolidation that occurs despite adequate age, appropriate time, and opportunity for sleep
• The sleep disturbance must not be attributable to either the direct physiologic effect of 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 of menses), must have confirmed negative pregnancy test prior to randomization and be using a recognized effective method of birth control (oral, implant, depot or transdermal oestroprogestatives, intrauterine device, double-barrier with spermicide). Abstinence is an acceptable method of birth control for this study.

You may not qualify if…

• Mental retardation
• Autistic spectrum disorder
• A history of sleep apnea
• A history of bipolar disorder, conduct disorder, major depression, or generalized anxiety disorder (not obsessive compulsive disorder), as determined by clinical interview 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 sleep aids

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — Laval, Canada

Full record on ClinicalTrials.gov

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