Beth Malow, M.D., M.S., professor of Neurology and Pediatrics, Burry Chair in Cognitive Childhood Development and Vanderbilt Kennedy Center investigator.
Malow said the study was designed to allow researchers to identify doses at which children responded to melatonin and also how long it took to observe a response.
Sleep difficulties, particularly insomnia, occur in 50 percent to 80 percent of children with ASD and are often accompanied by child and family distress.
“We are excited about the potential melatonin has for treating insomnia, which can be overwhelming to children with autism as well as their families,” Malow said. “The next step is to perform large-scale, controlled trials to prove that melatonin is effective in this population.”
Malow and colleagues recruited children ages 3-9 years with a clinical diagnosis of an ASD whose parents reported sleep onset delay of 30 minutes or longer on three or more nights per week.
Supplemental melatonin, given 30 minutes before bedtime, improved sleep latency in most children at 1 mg or 3 mg dosages.
Sleep latency, or the amount of time it takes a child to fall asleep, was measured by using an actigraph, which is a wrist-watch-like sensor worn by participants to monitor human rest/activity cycles.
Melatonin was effective in the first week of treatment, maintained effectiveness over several months, was well-tolerated and safe, and showed improvement in sleep, behavior and parenting stress, Malow said.
“While supplemental melatonin has shown promise in treating insomnia in our work and those of others, it is important that individuals with insomnia seek medical advice before taking melatonin,” Malow said. “This is because other treatable medical and sleep conditions can sometimes cause insomnia. Also, melatonin can interact with other drugs for other medical conditions.”
The study was supported with funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and Autism Speaks.
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