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Short- and long-term prolonged release melatonin treatment for sleep disorders in children with autism spectrum disorders – Results of a phase III randomized clinical trial

Journal of the American Academy of Child & Adolescent Psychiatry Oct 28, 2017

Findling RL, et al. - The authors evaluated the short- and long-term efficacy and safety of pediatric-appropriate prolonged-release melatonin formulation (pedPRM) vs placebo for sleep disorders in children with autism spectrum disorder (ASD) and other neurodevelopmental disorders. For the short- and long-term treatment of sleep disorders, pedPRM was effective and safe in children with ASD and other neurodevelopmental disorders. In a population who could have significant difficulties in swallowing, the formulation was well tolerated. For children with ASD who suffered from sleep disorders refractory to sleep behavioral interventions, pedPRM could provide a safe evidence-based pharmacological intervention.
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