Margaret D Weiss1, Michael B Wasdell2, Melissa M Bomben2, Kathleen J Rea2, Roger D Freeman2. 1. Dr. Weiss, Mr. Wasdell, and Ms. Bomben are with the Division of Child Psychiatry, University of British Columbia; Ms. Rea is with the Provincial ADHD Program, Childrenapos;s and Womenapos;s Health Centre of British Columbia; and Dr. Freeman is with the British Columbia Childrenapos;s Hospital and the Departments of Psychiatry and Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: mweiss@cw.bc.ca. 2. Dr. Weiss, Mr. Wasdell, and Ms. Bomben are with the Division of Child Psychiatry, University of British Columbia; Ms. Rea is with the Provincial ADHD Program, Childrenapos;s and Womenapos;s Health Centre of British Columbia; and Dr. Freeman is with the British Columbia Childrenapos;s Hospital and the Departments of Psychiatry and Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada.
Abstract
OBJECTIVE: To evaluate the efficacy of sleep hygiene and melatonin treatment for initial insomnia in children with attention-deficit/hyperactivity disorder (ADHD). METHOD: Twenty-seven stimulant-treated children (6-14 years of age) with ADHD and initial insomnia (>60 minutes) receivedsleep hygiene intervention. Nonresponders were randomized to a 30-day double-blind, placebo-controlled, crossover trial of 5-mg pharmaceutical-grade melatonin provided by the study's sponsor. RESULTS: Sleep hygiene reduced initial insomnia to <60 minutes in 5 cases, with an overall effect size in the group as a whole of 0.67. Analysis of the trial data able to be evaluated showed a significant reduction in initial insomnia of 16 minutes with melatonin relative to placebo, with an effect size of 0.6. Adverse events were generally mild and not different from those recorded with placebo treatment. The effect size of the combined sleep hygiene and melatonin intervention from baseline to 90 days' posttrial was 1.7, with a mean decrease in initial insomnia of 60 minutes. Improved sleep had no demonstrable effect on ADHD symptoms. CONCLUSION:Combined sleep hygiene and melatonin was a safe and effective treatment for initial insomnia in children with ADHD taking stimulant medication.
RCT Entities:
OBJECTIVE: To evaluate the efficacy of sleep hygiene and melatonin treatment for initial insomnia in children with attention-deficit/hyperactivity disorder (ADHD). METHOD: Twenty-seven stimulant-treated children (6-14 years of age) with ADHD and initial insomnia (>60 minutes) received sleep hygiene intervention. Nonresponders were randomized to a 30-day double-blind, placebo-controlled, crossover trial of 5-mg pharmaceutical-grade melatonin provided by the study's sponsor. RESULTS: Sleep hygiene reduced initial insomnia to <60 minutes in 5 cases, with an overall effect size in the group as a whole of 0.67. Analysis of the trial data able to be evaluated showed a significant reduction in initial insomnia of 16 minutes with melatonin relative to placebo, with an effect size of 0.6. Adverse events were generally mild and not different from those recorded with placebo treatment. The effect size of the combined sleep hygiene and melatonin intervention from baseline to 90 days' posttrial was 1.7, with a mean decrease in initial insomnia of 60 minutes. Improved sleep had no demonstrable effect on ADHD symptoms. CONCLUSION: Combined sleep hygiene and melatonin was a safe and effective treatment for initial insomnia in children with ADHD taking stimulant medication.
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