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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
Summary
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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