Supplemental melatonin has shown promise in treating sleep onset insomnia in children with autism spectrum disorders (ASD). Twenty-four children, free of psychotropic medications, completed an open-label doseescalation study to assess dose–response, tolerability, safety, feasibility of collecting actigraphy data, and ability of outcome measures to detect change during a 14-week intervention. Supplemental melatonin improved sleep latency, as measured by actigraphy, in most children at 1 or 3 mg dosages. It was effective in week 1 of treatment, maintained effects over several months, was well tolerated and safe, and showed improvement in sleep, behavior, and parenting stress. Our findings contribute to the growing literature on supplemental melatonin for insomnia in ASD and inform planning for a large randomized trial in this population.

Sleep difficulties, particularly insomnia, occur in 50–80% of children with autism spectrum disorders and are often accompanied by child and family distress. Disordered  sleep may exacerbate core and related symptoms of autism including social interactions, repetitive behaviors, affective problems, and inattention or hyperactivity. Therefore, interventions that target sleep may not only improve child health and child and family distress, but may also ameliorate core and related symptoms of autism.

Supplemental melatonin has a favorable side-effect profile and is inexpensive. Along with other complementary and alternative therapies, it has gained widespread acceptance by parents of children with ASD as an  alternative to FDA-approved medications. Three recent reviews have been published on the use of melatonin for insomnia in children with ASD. These reviews summarized the limitations of the existing literature, which includes small sample sizes (majority of studies containing 20 subjects or fewer), a mix of ASD with other neurodevelopmental disorders, limited controlled trials, and limited studies using objective outcome measures or examining dose–response or tolerability in a systematic fashion.

Although melatonin is safe and well tolerated, it should be administered under the treatment of a physician. This is because of the importance of assessing children with ASD and insomnia for medical, neurological, and psychiatric comorbidities, which may cause or contribute to insomnia.