期刊
JOURNAL OF AUTISM AND DEVELOPMENTAL DISORDERS
卷 52, 期 6, 页码 2784-2793出版社
SPRINGER/PLENUM PUBLISHERS
DOI: 10.1007/s10803-021-05139-w
关键词
Autism spectrum disorder; Melatonin; Sleep hygiene interventions; Sleep problems; Randomized controlled trial
资金
- Nobelpharma Co., Ltd.
The study demonstrates that melatonin is effective in treating sleep problems in children with ASD, significantly reducing sleep onset latency. This treatment regimen can be considered as an effective approach to address sleep difficulties in children with ASD.
Robust clinical evidence has not been available for melatonin, a drug commonly administered for treating sleep problems of children with autism spectrum disorder (ASD). In a phase 3 randomized, placebo-controlled clinical trial, we administered 1-mg melatonin (n = 65), 4-mg melatonin (n = 65), or placebo (n = 66) to196 children with ASD once daily before bedtime under adequate sleep hygiene interventions. The primary outcome was sleep onset latency (SOL) assessed with the electronic sleep diary. SOL shortened significantly in the 1- and 4-mg melatonin groups compared to the placebo group (- 22.0, - 28.0, and - 5.0 min, respectively; p < 0.0001 each). This therapeutic regimen of melatonin is a reasonable clinical approach to cope with ASD-emergent difficulties in children with ASD.
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