Prolonged-release melatonin for children with neurodevelopmental disorders

Hélène De Leersnyder1, Nava Zisapel, Moshe Laudon

  • 1Department of Genetics, Robert Debré Hospital, Paris, France. deleers@club-internet.fr

Pediatric Neurology
|July 5, 2011
PubMed

Insights

Prolonged-release melatonin effectively and safely treats sleep disorders in children with neurodevelopmental disorders. Long-term use significantly improves sleep onset, duration, quality, and reduces awakenings without serious adverse events.

Area of Science:

  • Pediatric Neurology
  • Sleep Medicine
  • Pharmacology

Background:

  • Previous studies indicated the efficacy and safety of prolonged-release melatonin (PRM) in children with neurodevelopmental and behavioral disorders.
  • Sleep disturbances are common in children with neurodevelopmental disorders, impacting their quality of life and daily functioning.

Purpose of the Study:

  • To assess the long-term effectiveness and safety of prolonged-release melatonin (PRM) in children with neurodevelopmental disorders.
  • To evaluate the impact of PRM on sleep parameters and mood in this pediatric population.

Main Methods:

  • A compassionate-use program in France involved 88 children (42 girls, 46 boys) with neurodevelopmental disorders treated with Circadin (2 mg PRM).
  • Treatment duration ranged from 6 to 72 months, with doses of 4-6 mg.
  • Parental questionnaires assessed sleep onset/offset, sleep quality, and mood.

Main Results:

  • Within 3 months, PRM significantly reduced sleep latency by 44.0% (P < 0.001).
  • Sleep duration increased by 10.1% (P < 0.001), and the number of awakenings decreased by 75% (P < 0.001).
  • Parent-reported sleep quality improved by 75% (P < 0.001) compared to baseline. No serious adverse events were reported.

Conclusions:

  • Prolonged-release melatonin (PRM) is a safe and effective long-term therapy for sleep disorders in children with neurodevelopmental disorders.
  • PRM demonstrates significant improvements in multiple sleep parameters and overall sleep quality.
  • The treatment is well-tolerated, with no reported serious adverse events or comorbidities.

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