drugset / Trial / 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

NCT00318448

Phase 3 Completed 201 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2006-04
Primary completion
2006-08
Completion
2006-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Zolpidem Small molecule 0.25 mg/kg