title: 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: Department of Genetics, Robert Debré Hospital, Paris, France. deleers@club-internet.fr
authors: Hélène
authors: H
authors: De Leersnyder
authors: Nava
authors: N
authors: Zisapel
authors: Moshe
authors: M
authors: Laudon
mesh_terms: D000293:Adolescent; D000975:Antioxidants / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D002658:Developmental Disabilities / Q000150:complications / Q000188:drug therapy*; D016503:Drug Delivery Systems / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008550:Melatonin / Q000008:administration & dosage*; D001523:Mental Disorders / Q000150:complications / Q000188:drug therapy*; D012893:Sleep Wake Disorders / Q000150:complications / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000975:Antioxidants; D008550:Melatonin