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

James E. Jan, Don Hamilton, Nadine Seward, Diane K. Fast, Roger D. Freeman, Moshe Laudon

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output

This is the first study to examine effective doses of controlled-release (CR) melatonin in children with chronic sleep–wake cycle disorders. All 42 subjects had severe neurodevelopmental difficulties. Initially, a randomized double-blinded cross-over design was used in 16 children, comparing the effectiveness of fast-release (FR) and CR melatonin. In the remainder of the patients, the CR melatonin was studied on a clinical basis. The effectiveness of treatment was assessed by sleep charts and clinical follow-up. Emphasis was placed on the judgement of the parents, who had guidance from the physicians. 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 when there was only delayed sleep onset, but CR formulations were more useful for sleep maintenance. Children appeared to require higher doses than adults.
Original languageEnglish
Pages (from-to)34-39
JournalJournal of pineal research
Issue number1
Publication statusPublished - May 2000

Keywords / Materials (for Non-textual outputs)

  • children
  • controlled release melatonin
  • melatonin
  • multidisabled
  • sleep disturbance


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