Prolonged-release melatonin for children with neurodevelopmental disorders.

Abstract

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.

• Authors: Hélène De Leersnyder, Nava Zisapel, Moshe Laudon
• Journal: Pediatric neurology (Pediatr Neurol) Vol. 45 Issue 1 Pg. 23-6 (Jul 2011) ISSN: 1873-5150 [Electronic] United States
• PMID: 21723455 (Publication Type: Clinical Trial, Journal Article)
• Copyright: Copyright © 2011 Elsevier Inc. All rights reserved.

Chemical References

• Antioxidants
• Melatonin

Topics

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