Journal of the American Academy of Child & Adolescent Psychiatry
ArticlesMelatonin Improves Health Status and Sleep in Children With Idiopathic Chronic Sleep-Onset Insomnia: A Randomized Placebo-Controlled Trial
Section snippets
METHOD
Elementary school children with idiopathic chronic sleep-onset insomnia were referred to our sleep center by local pediatricians and child psychologists. Criteria for participation were age between 6 and 12 and good general health. Sleep-onset insomnia was defined as an inability to fall asleep at an appropriate time in the evening with an idiopathic nature. Sleep onset had to be later than 8:30 pm in children aged 6 years and for older children 15 minutes later per year until age 12. The
RESULTS
Seventy-nine white children underwent screening for possible study inclusion. Three were excluded because of psychiatric comorbidity (anxiety, 2; depression, 1) and six because their insomnia could be caused by poor limit setting. Seventy children were randomly assigned to melatonin or placebo treatment. During the baseline week, eight parents withdrew informed consent because they heard enthusiastic reports on the effectiveness of melatonin. Ten children did not produce saliva for determining
DISCUSSION
Four weeks of treatment with melatonin was shown to be more effective in improving health status and sleep than placebo in elementary school children with idiopathic chronic sleep-onset insomnia. Serious short-term adverse events did not occur.
The children treated with melatonin slept better, ate better, seemed to be less sick and tired, were more lively, and responded better to attention (FS-II) and were considered to be healthier (RAND-GHRI) than those treated with placebo. Interestingly,
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This study was financially supported by the Jan Dekker en dr. Ludgardine Bouwman Foundation.
The authors thank M. van Loenhout and M. Kleiwerd for collecting the data and I. M. van Geijlswijk, Pharm.D., for preparation of the study medication.