Last Updated: 2009-05-01 12:09:03 -0400 (Reuters Health)

Treatment with zolpidem, a non-benzodiazepine hypnotic agent, does not significantly reduce the latency to sleep onset in children with insomnia related to attention-deficit/hyperactivity disorder (ADHD), according to results of a study published in the May issue of Pediatrics.

"Although there has been research on sleep hygiene/behavioral therapies, there are no published, randomized, controlled trials of pharmaceutical therapies for pediatric sleep disturbance," Dr. Jeffrey L. Blumer of University Hospitals, Case Medical Center, Cleveland, Ohio, and colleagues write. "An increased prevalence of insomnia has been described for children with ADHD, regardless of whether they are receiving stimulants."

In an 8-week, multicenter, double-blind, placebo-controlled study, the researchers assessed the hypnotic efficacy of zolpidem at 0.25 mg/kg per day (maximal dosage of 10 mg/day), compared with placebo, in 201 children 6 to 17 years of age with ADHD-associated insomnia. Of these, 136 received zolpidem and 65 received placebo.

The main outcome measure was latency to persistent sleep (LPS) measured between weeks 3 and 4 or between weeks 4 and 6. There was no significant difference in LPS between treatment groups at week 4, the team reports. The mean reduction from baseline was -20.28 minutes with zolpidem and -21.27 minutes with placebo.

At weeks 4 and 8, differences in Clinical Global Impression scores favoring zolpidem were found in the older children, those 12 to 17 years of age.

There were no next-day residual effects observed. No significant difference was found between the groups in rebound worsening in LPS after treatment discontinuation.

Overall, 62.5% of zolpidem-treated patients and 47.7% of placebo-treated patients experienced at least one treatment-emergent adverse event. These included dizziness, headache, and hallucinations. Ten patients in the zolpidem group and none in the placebo group discontinued treatment because of treatment-emergent adverse events.

"The severity of insomnia in a subset of pediatric patients with a lack of response to behavioral interventions demands further study of the pharmacotherapy of insomnia in children and adolescents, particularly patients with comorbid ADHD and oppositional defiant disorder," Dr. Blumer’s team concludes. "Head-to-head trials against currently used agents may be warranted to determine whether various subgroups of patients respond differently."

Pediatrics 2009;123:770-776.