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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00318448
Recruitment Status : Completed
First Posted : April 26, 2006
Last Update Posted : April 7, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: Zolpidem (SL800750) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : April 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Primary Outcome Measures :
  1. Latency to persistent sleep (LPS) measured by polysomnography

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00318448

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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office
Laval, Canada
Sponsors and Collaborators
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Study Director: ICD CSD Sanofi

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00318448    
Other Study ID Numbers: EFC6820
First Posted: April 26, 2006    Key Record Dates
Last Update Posted: April 7, 2009
Last Verified: April 2009
Keywords provided by Sanofi:
Child Psychology
Pediatric Psychology
Additional relevant MeSH terms:
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Nervous System Diseases
Central Nervous System Depressants
Sleep Initiation and Maintenance Disorders
Attention Deficit Disorder with Hyperactivity
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Neurologic Manifestations
Signs and Symptoms
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action