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Schroder, Carmen M.; Malow, Beth A.; Maras, Athanasios; Melmed, Raun D.; Findling, Robert L.; Breddy, John; Nir, Tali; Shahmoon, Shiri; Zisapel, Nava; Gringras, Paul – Journal of Autism and Developmental Disorders, 2019
A randomized, 13-weeks, placebo-controlled double-blind study in 125 subjects aged 2-17.5 years with Autism Spectrum Disorder or Smith-Magenis syndrome and insomnia demonstrated efficacy and safety of easily-swallowed prolonged-release melatonin mini-tablets (PedPRM; 2-5 mg) in improving sleep duration and onset. Treatment effects on child…
Descriptors: Autism, Pervasive Developmental Disorders, Genetic Disorders, Sleep

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