by Jim Kling
June 10, 2009 (Seattle, Washington) — A pilot study in children with autism spectrum disorders (ASD) suggests that low-dose melatonin may be an effective treatment for insomnia in these patients. In this study, positive effects of treatment were seen on both sleep and daytime behavior.
Melatonin "does appear to be effective," Beth Malow, MD, professor of neurology at Vanderbilt University, in Nashville, Tennessee, said during her presentation. She emphasized that the study was small and that more work needs to be done.
"Kids with autism who have some sleep problems are candidates for melatonin, and I believe that large, randomized clinical trials of melatonin are well warranted," she concluded.
Dr. Malow presented the findings here at SLEEP 2009: 23rd Annual Meeting of the Associated Professional Sleep Societies.
Increasing Melatonin Use
Children with ASD may experience insomnia, the researchers note, and parents are increasingly turning to melatonin as a sleep aid. However, not much is known about its potential adverse effects. Melatonin also comes in a wide variety of formulations, some with additives such as antihistamines or vitamins.
Parents perceive melatonin as a natural treatment, but the wide variety of formulations makes it difficult for practicing physicians to assess its utility. "I don't know what they're taking," said 1 attendee, referring to his autistic patients.
To better assess melatonin's safety and efficacy in autistic children, the researchers conducted a 17-week study of children with ASD who had trouble falling asleep.
The study enrolled children aged 4 to 10 years diagnosed with ASD who required at least 30 minutes to fall asleep on 3 out of 7 nights of the week. Parents received behavioral sleep education before melatonin treatments began, and this was continued through the study. Parents filled out sleep and behavioral survey forms at the beginning and end of all study procedures. Patients wore actigraphy watches (Respironics) for 17 weeks.
After 3 weeks, patients were given 1-mg melatonin (Natrol). Every 3 weeks thereafter, the dose was escalated to 3 mg, 6 mg, and 9 mg, until the patient fell asleep within 30 minutes at least 5 out of 7 nights per week. Pre- and posttreatment actigraphy measures were analyzed using a Wilcoxon signed-ranks test.
Ten patients completed the study with no adverse effects. Three required a dose of 1 mg, 5 required 3 mg, and 2 required 6 mg to achieve the desired end point. No patients required a 9-mg dose.
Patients started with a mean sleep latency of 38.7 minutes that was reduced to a mean of 21.8 minutes with treatment (P = 0.039).
The Children's Sleep Habits Questionnaire showed improvement in sleep-onset delay (P = 0.008) and sleep duration (P = 0.004), repetitive-behavior scale domains of compulsive (P = 0.002) and ritualistic behavior (P = 0.004), and Parent Interview for Autism domain of affective responses (P = 0.02).
Definite Promise
Asked for perspective on these findings, Judith Owens, MD, professor of pediatrics at Brown Medical School, in Providence, Rhode Island, who moderated the session, said the data support the safety, tolerability, and efficacy of melatonin in this patient population.
"This was open label, so you can't get solid conclusions of efficacy, but it definitely has promise," Dr. Owens told Medscape Neurology.
The project was supported by grants from the Autism Speaks/Dana Foundation, the National Institutes of Health, and Vanderbilt University. Melatonin was provided by Natrol. Dr. Malow and Dr. Owens have disclosed no relevant financial relationships.
SLEEP 2009: 23rd Annual Meeting of the Associated Professional Sleep Societies: Abstract 0189. Presented June 8, 2009.
Jim Kling is a freelance writer for Medscape.
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