@article{38f3c3d5ce494bf0bd26d178682c09db,
title = "Pediatric Prolonged-Release Melatonin for Sleep in Children with Autism Spectrum Disorder: Impact on Child Behavior and Caregiver{\textquoteright}s Quality of Life",
abstract = "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 behavior and caregiver{\textquoteright}s quality of life were evaluated. PedPRM treatment resulted in significant improvement in externalizing but not internalizing behavior (Strengths and Difficulties questionnaire; SDQ) compared to placebo (p = 0.021) with clinically-relevant improvements in 53.7% of PedPRM-treated versus 27.6% of placebo-treated subjects (p = 0.008). Caregivers{\textquoteright} quality of life also improved with PedPRM versus placebo (p = 0.010) and correlated with the change in total SDQ (p = 0.0005). PedPRM alleviates insomnia-related difficulties, particularly externalizing behavior in the children, subsequently improving caregivers{\textquoteright} quality of life.",
keywords = "Autism, Behavior, Children (pediatric), Prolonged-release melatonin, Sleep",
author = "Schroder, {Carmen M.} and Malow, {Beth A.} and Athanasios Maras and Melmed, {Raun D.} and Findling, {Robert L.} and John Breddy and Tali Nir and Shiri Shahmoon and Nava Zisapel and Paul Gringras",
note = "Funding Information: The study was funded by Neurim Pharmaceuticals Ltd. Funding Information: We would like to thank the study participants and their families for their cooperation and commitment. We thank all members of the trial team for their active contribution. We express our sincere gratitude to Dr. Moshe Laudon for developing the investigational drug and to Dr. Amnon Katz for his help with the study design and research. Moreover, a sincere gratitude to all investigators that participated in the study: Dr. Roshan Raja, Clinical Research Center of Nevada; Dr. Markku Partinen, P?ij?t-H?me Central Hospital; Dr. Amanda Bennett, Children?s Hospital of Philadelphia; Dr. Samantha Bostrom, Ericksen Research & Development; Dr. Karen Hillock, Lake Mary Pediatrics; Dr. Lawrence Ginsberg, Red Oak Psychiatry Association; Dr. Thomas Challman, Geisinger Health Systems; Dr. Catherine Hill, University Hospital Southampton NHS Foundation Trust; Dr. Megan Thomas, Blackpool Victoria Hospital NHS Trust; Dr. Marcel G Smits, Ziekenhuis Gelderse Vallei; Dr. Jerry Tomasovic, Road Runner Research; Dr. Ralph Gallo, Clinical Research Center; Dr. Laszlo Mate; Dr Angel. Rico, Crystal Biomedical Research; Dr. Rajinder Shiwach, Insite Clinical Research; Dr. Jean-Marc Pinard, H?pital Raymond Poincar?; Dr. Chetana Kallappa, Birmingham Childrens Hospital NHS Trust, Dr. Dennis Bastiaansen, Yulius Autisme, Yulius Mental Health Organization and Bj?rn Jaime van Pelt, MS, Researcher, Yulius Autisme, Yulius Mental Health Organization. Publisher Copyright: {\textcopyright} 2019, The Author(s).",
year = "2019",
month = aug,
day = "15",
doi = "10.1007/s10803-019-04046-5",
language = "English (US)",
volume = "49",
pages = "3218--3230",
journal = "Journal of Autism and Developmental Disorders",
issn = "0162-3257",
publisher = "Springer New York",
number = "8",
}