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)

Sanofi

Status and phase

Completed

Phase 3

Conditions

Attention Deficit Hyperactivity Disorder

Treatments

Drug: Zolpidem (SL800750)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00318448

EFC6820

Details and patient eligibility

About

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.

Full 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.

Enrollment

201 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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