Clinical trials of controlled-release melatonin in children with sleep-wake cycle disorders

This is the first study to examine effective doses of controlled-release (C R) melatonin in children with chronic sleep-wake cycle disorders. All 42, s ubjects had severe neurodevelopmental difficulties. Initially, a randomized double-blinded cross-over design was used in 16 children, comparing the ef fectiveness of fast-release (FR) and CR melatonin. In the remainder of the patients, the CR melatonin was studied on a clinical basis. The effectivene ss of treatment was assessed by sleep charts and clinical follow-up. Emphas is was placed on the judgement of the parents, who had guidance from the ph ysicians. The average final CR melatonin dose in the 42 patients was 5.7 mg (2-12 mg). The studies showed that the FR melatonin was most effective whe n there was only delayed sleep onset, but CR formulations were more useful for sleep maintenance. Children appeared to require higher doses than adult s.