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More Evidence that Melatonin Eases Autism-Associated Insomnia

When taken regularly, a nightly dose of melatonin helps children with autism and insomnia fall asleep, according to a pilot study published today.

The 24 children, ages 3 to 9, who completed the 14-week treatment, differed somewhat in the dose they required. Yet in all cases, a nightly regimen of melatonin (1 – 6 mg) helped with sleep onset within a week’s time. The group data indicated that benefits generally lasted for the length of the study, with no significant side effects. Parents also reported improvements in their children’s daytime behavior and reductions in their own stress levels.

The study, which appears in the online edition of the Journal of Autism and Developmental Disorders, was funded by Autism Speaks and the Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD).

More than half of all children with autism spectrum disorder (ASD) struggle with sleep disorders--insomnia being the most common, explains lead researcher Beth Malow, M.D., M.S., a professor of neurology, pediatrics and cognitive child development at the Vanderbilt University School of Medicine, in Nashville. Malow is also the principal investigator for Vanderbilt’s Autism Speaks Autism Treatment Network (ATN) site.

Many adolescents and adults with autism likewise struggle with sleep disturbances, Malow notes.

More than a trivial matter, disordered sleep can worsen autism symptoms such as repetitive behaviors and social difficulties. In addition, parents and other caregivers report that autism-associated insomnia can take a toll on the entire household.

In recent years, melatonin, the so-called “sleep hormone,” has become popular among families and individuals affected by ASD, given the relatively low cost of melatonin supplements and their apparent safety.

Unfortunately, high quality studies have been lacking. Those completed so far have been very small, retrospective (relying on recollection rather than direct observation) or included children who did not have autism. The latter is a problem because sleep disturbances associated with ASD may have different root causes than those experienced by people without autism.

To close this information gap, Autism Speaks and the NINDS co-sponsored the new pilot study to determine what doses of melatonin, if any, produce real benefits in children with ASD and to screen for any problematic side effects. In addition, the researchers used a liquid form of melatonin approved by the Food and Drug Administration for clinical research use in children with autism (Natrol ®). (Past studies used a variety of different melatonin preparations, a concern because nonprescription nutritional supplements can vary widely in quality.)

All of the 24 preschoolers and grade-schoolers who completed the study had confirmed diagnoses of ASD in addition to parent reports that that they did not fall asleep within 30 minutes of “lights out” three or more nights a week. The benchmark for a positive response to the melatonin was falling asleep within 30 minutes five or more nights a week.

Seven of the participating children achieved this positive response with a 1 mg nightly dose of melatonin taken 30 minutes before bedtime. Another fourteen responded after being increased to a 3 mg dose, and three required a 6 mg dose. Age and weight did not appear to determine the dose required, and none of the dose levels produced worrisome side effects.

Malow cautions that families and individuals dealing with autism-associated insomnia should consult a physician rather than try melatonin on their own. “There are lots of causes for sleep disturbances,” she explains. “It is vitally important to first identify and treat any underlying medical condition.” All children enrolled in the study were first evaluated by a medical specialist for potential contributory conditions such as gastrointestinal disease or sleep apnea and received treatment if needed. The researchers also taught parents how to implement good sleep habits with their children, and only those whose insomnia persisted after this behavioral intervention entered the melatonin-treatment trial.

The positive results of this pilot study are very encouraging, says Autism Speaks Chief Science Officer Geri Dawson, Ph.D. The next step is to confirm the suggestion of benefit with larger, placebo-controlled trials. This is important because placebos (inactive supplements or “dummy” medicines) can themselves have a beneficial effect, owing to the power of suggestion. In addition, studies with many more participants are needed to confirm melatonin’s benefit and safety.  

One such placebo-controlled study, at Houston’s Baylor College of Medicine,is now underway, thanks to support from Autism Speaks donors and volunteers. In addition, Autism Speaks recently funded a study at the University of Colorado at Denver on noninvasive ways to measure melatonin levels in children with autism and insomnia. To explore more of the studies Autism Speaks is funding, please visit our website’s grant search. For helpful information on easing autism-related insomnia, see Autism Speaks Family Service resource page on “Sleep and Autism Spectrum Disorder.”

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