Prolonged-release melatonin for children with neurodevelopmental disorders

Pediatr Neurol. 2011 Jul;45(1):23-6. doi: 10.1016/j.pediatrneurol.2011.02.001.


Previous studies demonstrated the efficacy and safety of prolonged-release melatonin in children and adolescents with neurodevelopmental and behavioral disorders. The long-term effectiveness and safety of prolonged-release melatonin treatment were assessed in 88 children (42 girls and 46 boys) with neurodevelopmental disorders. These patients participated in a compassionate-use program with the drug Circadin (2 mg; Neurim Pharmaceuticals, Tel Aviv, Israel) in France, and received treatment in the context of regular care by a specialized physician. The study involved a structured questionnaire for the parents, comprising a combination of multiple-choice and numeric questions addressing sleep onset/offset, sleep quality problems, and mood. The dose of melatonin ranged from 4-6 mg, and treatment duration ranged from 6-72 months. Within 3 months, sleep latency with prolonged-release melatonin decreased by 44.0% (P < 0.001), sleep duration increased by 10.1% (P < 0.001), the number of awakenings decreased by 75% (P < 0.001), and sleep quality improved by 75%, compared with baseline (P < 0.001). No serious adverse events or treatment-related comorbidities were reported. Prolonged-release melatonin remains a safe, effective therapy for the long-term treatment of sleep disorders in children with neurodevelopmental disorders.

Publication types

  • Clinical Trial

MeSH terms

  • Adolescent
  • Antioxidants / administration & dosage*
  • Child
  • Child, Preschool
  • Developmental Disabilities / complications
  • Developmental Disabilities / drug therapy*
  • Drug Delivery Systems / methods
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Melatonin / administration & dosage*
  • Mental Disorders / complications
  • Mental Disorders / drug therapy*
  • Sleep Wake Disorders / complications
  • Sleep Wake Disorders / drug therapy*
  • Treatment Outcome


  • Antioxidants
  • Melatonin