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

Condition(s) targeted: Attention Deficit Hyperactivity Disorder

Intervention: Zolpidem (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi-Aventis

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.

Official title: Efficacy, Safety and Tolerability of Zolpidem in the Treatment of Children Aged 6 to 17 Years With ADHD-Associated Insomnia. A Multicentre, Randomized, Double-Blind, Placebo-Controlled Study

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Latency to persistent sleep (LPS) measured by polysomnography

Secondary outcome:

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

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.

Minimum age: 6 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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.

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

Sanofi-Aventis, Bridgewater, New Jersey 08807, United States

Sanofi-Aventis, Laval, Quebec H7L4A8, Canada

Starting date: April 2006
Last updated: September 7, 2006