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

Phase 3

Completed

• Conditions: Attention Deficit Hyperactivity Disorder

• Registration Number: NCT00318448
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

The study is being conducted in the United States. It consists of 3 segments:

* Segment A: 2 to 21 day screening period

* Segment B: 8-week double-blind treatment period

* Segment C: 1-week follow-up period

Subjects will have a polysomnography in a sleep lab two times during the study (at baseline and between visit 4-5) and also be required to wear an actigraphy monitoring tool. There will be several questionnaires completed throughout the study: CGI-child, CGI-parent/legal guardian, ADHD Rating Scale-IV, and the Pediatric Daytime Sleepiness Scale.

Study Timeline

• Study First Submitted: 2006-03-14
• Study Start: 2006-04
• Study First Submitted QC: 2006-04-25
• Study First Posted: 2006-04-26
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-06
• Last Update Posted: 2009-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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 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.

Read More

Exclusion Criteria

• 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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Latency to persistent sleep (LPS) measured by polysomnography

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression (CGI) Severity and Global Improvement item scores (from child and parent/legal guardian scales)
Actigraphy measures of sleep characteristics
ADHD Rating Scale-IV
School tardiness/Attendance Reports
Adverse events
PE, lab

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇨🇦 Laval, Canada