An Open-Label Study of Controlled-Release Melatonin in Treatment of Sleep Disorders in Children with Autism
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Long-term effectiveness of controlled-release melatonin in 25 children, aged 2.6–9.6 years with autism without other coexistent pathologies was evaluated openly. Sleep patterns were studied using Children’s Sleep Habits Questionnaire (CSHQ) and sleep diaries at baseline, after 1–3–6 months melatonin treatment and 1 month after discontinuation. Sleep diary and CSHQ showed a more problematic sleep in autistic children compared with controls. During treatment sleep patterns of all children improved. After discontinuation 16 children returned to pre-treatment score, readministration of melatonin was again effective. Treatment gains were maintained at 12 and 24-month follow-ups. No adverse side effects were reported. In conclusion, controlled-release melatonin may provide an effective and well-tolerated treatment for autistic children with chronic sleep disorders.