Can Eszopiclone Help ADHD-Associated Insomnia in Youth?
the MPR take:
Insomnia and other sleep difficulties are estimated to impact as many as 50–60% of children and adolescents with attention-deficit/hyperactivity disorder (ADHD); however, no products indicated for the treatment of insomnia are currently approved for use in the pediatric population. As well, there is little evidence of the safety and efficacy of over-the-counter and prescription medications used to treat insomnia in this population. A 12-week randomized, double-blind, placebo-controlled multicenter study sought to assess the safety and efficacy of eszopiclone in the treatment of 486 children and adolescents ages 6–17 with ADHD-associated insomnia, followed by a 2-week, single-blind washout period to evaluate rebound effects. Patients were randomized to receive low-dose eszopiclone (1mg for children ages 6–11, 2mg for adolescents ages 12–17), high-dose eszopiclone (2mg for ages 6–11, 3mg ages 12–17), or placebo. No significant difference was seen from baseline to week 12 in polysomnography-measured latency to persistent sleep (time from lights-out to the beginning of the first sleep period of at least 10 minutes’ duration) with low- or high-dose eszopiclone vs. placebo. Although eszopiclone was generally well-tolerated in both the double-blind and a follow-up open-label study, it failed to demonstrate efficacy in this population. The authors hypothesize that the benzodiazepine binding site on the GABAA receptor may be the incorrect pharmacologic target, and that insomnia in children and adolescents with ADHD may be linked to a melatonin-mediated, circadian-based sleep delay.
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