Controlled clinical trial of zolpidem for the treatment of insomnia associated with attention-deficit/hyperactivity disorder in children 6 to 17 years of age

Jeffrey L. Blumer, Robert L. Findling, Weichung Joe Shih, Christina Soubrane, Michael D. Reed

Research output: Contribution to journalArticlepeer-review

49 Scopus citations

Abstract

OBJECTIVE. The goal was to evaluate the hypnotic efficacy of zolpidem at 0.25 mg/kg per day (maximum of 10 mg/day), compared with placebo, in children 6 through 17 years of age who were experiencing insomnia associated with attention-deficit/hyperactivity disorder. METHODS. An 8-week, North American, multicenter, double-blind, placebo-controlled, parallel-group study was conducted. Patients underwent stratification according to age (6-11 years [N = 111] or 12-17 years [N = 90]) and were assigned randomly to receive treatment with the study drug or placebo (in a 2:1 ratio). The primary efficacy variable was latency to persistent sleep between weeks 3 and 6. Secondary efficacy variables also were assessed, and behavioral and cognitive components of attention-deficit/hyperactivity disorder were monitored. Safety was assessed on the basis of reports of adverse events, abnormal laboratory data, vital signs, and physical examination findings. The potential for next-day residual effects also was assessed. RESULTS. The baseline-adjusted mean change in latency to persistent sleep at week 4 did not differ significantly between the zolpidem and placebo groups (-20.28 vs -21.27 minutes). However, differences favoring zolpidem were observed for the older age group in Clinical Global Impression scores at weeks 4 and 8. No next-day residual effects of treatment were associated with zolpidem, and no rebound phenomena occurred after treatment discontinuation. Central nervous system and psychiatric disorders were the most-frequent treatment-emergent adverse events (>5%) that were observed more frequently with zolpidem than with placebo; these included dizziness, headache, and hallucinations. Ten (7.4%) patients discontinued zolpidem treatment because of adverse events. CONCLUSION. Zolpidem at a dose of 0.25 mg/kg per day to a maximum of 10 mg failed to reduce the latency to persistent sleep on polysomnographic recordings after 4 weeks of treatment in children and adolescents 6 through 17 years of age who had attention-deficit/hyperactivity disorder-associated insomnia.

Original languageEnglish (US)
Pages (from-to)e770-e776
JournalPediatrics
Volume123
Issue number5
DOIs
StatePublished - May 2009
Externally publishedYes

Keywords

  • Attention-deficit/hyperactivity disorder
  • Insomnia
  • Latency to persistent sleep
  • Zolpidem

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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