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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
201
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Laval, Canada
Latency to persistent sleep (LPS) measured by polysomnography
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.