Onset and stability of melatonin treatment effect in childhood sleep onset insomnia

ABSTRACT Backgroud and objective: To evaluate onset and stability of therapeutic effect of 4-week melatonin treatment for chronic sleep onset insomnia in elementary school-aged children. Methods: Retrospective analysis of unpublished data obtained from two previously published randomized, double-blind and placebo-controlled trials on melatonin treatment efficacy for childhood insomnia in children with chronic sleep onset insomnia, age 6-12 years (n=49). Intervention consisted of placebo (n=25) or melatonin 5 mg (n=24) administered at 6 (n=9) or 19h (n=40) during four weeks. Collected data were “light-out time”, “sleep onset latency”, “sleep onset”, “total sleep time”, “wake-up time”, and subjective sleep measures recorded in a diary. Results: Melatonin treatment showed a phase-advance of lights out of 21h15 (1.05) to 20h28 (1.07); sleep onset advanced from 22h05 (0.93) to 20h45 (1.09) and sleep latency decreased from 53 (39) to 18 minutes (16). After the 4-week trial period, these values were 20h44 (1.27), 21h09 (1.33), 25 minutes (39). Conclusions: Melatonin advances sleep latency and sleep onset and increases total sleep time starting right from the first treatment night in children with chronic sleep onset insomnia. Evidence is provided that the onset of melatonin treatment effect can be expected within a few days after commencement and, then, remains stable.