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

J E Jan1, D Hamilton, N Seward

  • 1Visually Impaired Program, BC's Children's Hospital, Vancouver, Canada. jjan@cw.bc.ca

Journal of Pineal Research
|August 19, 2000
PubMed

Insights

This study explored controlled-release (CR) melatonin doses for children with chronic sleep disorders. CR melatonin effectively improved sleep maintenance in children with neurodevelopmental difficulties, often requiring higher doses than adults.

Area of Science:

  • Pediatric Neurology
  • Sleep Medicine
  • Pharmacology

Background:

  • Chronic sleep-wake cycle disorders are prevalent in children with severe neurodevelopmental difficulties.
  • Limited research exists on effective melatonin dosing for this population.

Purpose of the Study:

  • To investigate the effective doses of controlled-release (CR) melatonin in children with chronic sleep-wake cycle disorders.
  • To compare the effectiveness of fast-release (FR) and CR melatonin formulations.

Main Methods:

  • A randomized double-blinded cross-over design was initially used for 16 children.
  • CR melatonin was further studied on a clinical basis for the remaining patients (total N=42).
  • Effectiveness was assessed using sleep charts, clinical follow-up, and parental feedback.

Main Results:

  • The average final CR melatonin dose was 5.7 mg (range: 2-12 mg).
  • Fast-release (FR) melatonin was more effective for delayed sleep onset.
  • Controlled-release (CR) melatonin formulations were superior for sleep maintenance.

Conclusions:

  • Controlled-release melatonin is a viable treatment for sleep maintenance issues in children with neurodevelopmental disorders.
  • Children may require higher melatonin doses compared to adults.
  • Further research into optimal CR melatonin dosing for pediatric sleep disorders is warranted.

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