Melatonin for Sleep in Children With Autism
| Status: | Archived |
|---|---|
| Conditions: | Insomnia Sleep Studies, Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | January 2008 |
| End Date: | October 2010 |
Melatonin for Sleep in Children With Autism: Safety Tolerability and Dose
The purpose of this study is to determine if liquid supplemental melatonin is an effective
treatment for children with autism who have sleep problems related to insomnia (difficulty
falling asleep).
Sleep difficulties in children with autism spectrum disorders (ASD) are common reasons why
parents seek medical intervention for their children. Identifying a safe and effective
pharmacologic agent that promotes sleep in ASD would favorably impact the lives of these
children and their families. In this study we plan to determine the dose-response,
tolerability and any adverse effects of supplemental melatonin in 30 children with ASD.The
melatonin dose levels are 1mg, 3mg, 6mg, and 9mg. After a 3 week baseline period, the child
will begin melatonin at 1mg and will dose escalate every three weeks until he/she is falling
asleep within 30 minutes of bedtime at least 5/7 nights per week. No child will take more
than 9 mg of supplemental melatonin.
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