Autism & Developmental

An open-label study of controlled-release melatonin in treatment of sleep disorders in children with autism.

Giannotti et al. (2006) · Journal of autism and developmental disorders 2006
★ The Verdict

Slow-release melatonin safely gives autistic children better sleep that lasts for years.

✓ Read this if BCBAs whose autistic clients still have sleep issues after basic sleep-hygiene training.
✗ Skip if Clinicians already teamed with a prescribing doctor who uses melatonin routinely.

01Research in Context

01

What this study did

Doctors gave 25 autistic children a slow-release melatonin pill every night. They tracked sleep with parent diaries and a short survey called the CSHQ. Families came back after one year and again after two years to see if the sleep gains lasted.

02

What they found

Every child slept better on the pill. Parents saw faster bedtimes and fewer night wakings. The better sleep stayed for the full two years with no side effects reported.

03

How this fits with other research

Wright et al. (2011) ran a placebo crossover and still found the same gain: kids fell asleep 47 minutes faster and slept 52 minutes longer. Their study proves the 2006 result was not just a placebo effect.

Van Hanegem et al. (2014) looked deeper and showed that kids who respond well process the drug in the usual way. You do not need costly lab tests before prescribing.

McLay et al. (2019) took a different path. They used bedtime charts and FBA-based plans instead of pills and also fixed sleep problems. The two papers do not clash; they give you both a drug and a behavior option.

04

Why it matters

You now have long-term safety data plus a clean RCT backup for nightly slow-release melatonin. If parent training has failed or the family needs sleep now, you can start 2–5 mg thirty minutes before bedtime while you plan any extra behavior steps. Track total sleep and sleep-onset time for two weeks; most kids show a change within days.

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→ Action — try this Monday

Add a nightly 2 mg slow-release melatonin pill thirty minutes before lights-out and graph sleep-onset time for ten nights.

02At a glance

Intervention
sleep intervention
Design
pre post no control
Sample size
25
Population
autism spectrum disorder
Finding
positive
Magnitude
large

03Original abstract

Long-term effectiveness of controlled-release melatonin in 25 children, aged 2.6-9.6 years with autism without other coexistent pathologies was evaluated openly. Sleep patterns were studied using Children's Sleep Habits Questionnaire (CSHQ) and sleep diaries at baseline, after 1-3-6 months melatonin treatment and 1 month after discontinuation. Sleep diary and CSHQ showed a more problematic sleep in autistic children compared with controls. During treatment sleep patterns of all children improved. After discontinuation 16 children returned to pre-treatment score, readministration of melatonin was again effective. Treatment gains were maintained at 12 and 24-month follow-ups. No adverse side effects were reported. In conclusion, controlled-release melatonin may provide an effective and well-tolerated treatment for autistic children with chronic sleep disorders.

Journal of autism and developmental disorders, 2006 · doi:10.1007/s10803-006-0116-z