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Melatonin Improves Health Status and Sleep in Children With Idiopathic Chronic Sleep-Onset Insomnia: A Randomized Placebo-Controlled Trial

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ABSTRACT

Objective

To investigate the effect of melatonin treatment on health status and sleep in children with idiopathic sleep-onset insomnia.

Method

A randomized, double-blind, placebo-controlled trial was conducted in a Dutch sleep center, involving 62 children, 6 to 12 years of age, who suffered more than 1 year from idiopathic chronic sleep-onset insomnia. Patients received either 5 mg melatonin or placebo at 7 pm. The study consisted of a 1-week baseline period, followed by a 4-week treatment. Health status was measured with the RAND General Health Rating Index (RAND-GHRI) and Functional Status II (FS-II) questionnaires. Lights-off time, sleep onset, and wake-up time were recorded in a diary, and endogenous dim light melatonin onset was measured in saliva.

Results

The total scores of the RAND-GHRI and FS-II improved significantly more during melatonin treatment compared to placebo. The magnitude of change was much higher in the melatonin group than in the placebo group, with standardized response means for the RAND-GHRI of 0.69 versus 0.07 and for the FS-II of 1.61 versus 0.64. Melatonin treatment also significantly advanced sleep onset by 57 minutes, sleep offset by 9 minutes, and melatonin onset by 82 minutes, and decreased sleep latency by 17 minutes. Lights-off time and total sleep time did not change.

Conclusions

Melatonin improves health status and advances the sleep–wake rhythm in children with idiopathic chronic sleep-onset insomnia.

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.

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