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Completed

NCT Number: NCT00318448

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

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Dyssomnias Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office, Laval, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zolpidem (SL800750)

Drug

Primary outcomes

  1. Latency to persistent sleep (LPS) measured by polysomnography

Secondary outcomes

  1. Clinical Global Impression (CGI) Severity and Global Improvement item scores (from child and parent/legal guardian scales)

  2. Actigraphy measures of sleep characteristics

  3. ADHD Rating Scale-IV

  4. School tardiness/Attendance Reports

  5. Adverse events

  6. PE, lab

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: Zolkids

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Apr 26, 2006
Registry last updated
Apr 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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