Safety & Efficacy of Melatonin Use in Small Children


This review article covers key studies on the use of melatonin in pediatrics, including its use for children’s sleep disorders, pediatric anesthesia, epilepsy and febrile seizures, adolescent idiopathic scoliosis, neonatal care, and the feeding of newborns.

Key Findings

Melatonin use in children has been well-studied to date, and research suggests efficacy for several conditions. Melatonin has been most studied for its chronobiotic (sleep modulation) effects in various pediatric populations. Experimental models have also demonstrated usefulness as an antioxidant. Inconsistent benefit has been found in studies on its analgesic/anxiolytic use in pediatric populations. No significant side effects of melatonin use in children have been reported.

Practice Implications

This review article provides very interesting information in support of melatonin’s use for several pediatric conditions.Most interesting is the use of melatonin in children’s insomnia, a condition for which there are no approved pharmaceutical drugs. Most pediatricians and primary care physicians rely on behavioral treatments for insomnia, but a growing number of physicians are recommending melatonin, based on a 2003 survey in the journal Pediatrics.1 This review summarizes studies on general dyssomnias in addition to sleep disturbances associated with autism spectrum disorders (ASD), attention-deficit hyperactivity disorder (ADHD), and other mental or neurological disorders or disabilities.

In general, these dyssomnias are associated with a difficult time initiating or maintaining sleep. Administration of melatonin has been associated with faster sleep onset, as well as increased sleep duration. The greatest effect is seen with advancing sleep onset, and the most benefit is achieved when melatonin is dosed approximately 30–60 minutes before desired bedtime. Doses used in the studies ranged from 0.5 to 9 mg, and positive effects were seen at all doses. The longest-term study evaluating melatonin use for insomnia was conducted in children with ADHD. This study surveyed parents whose children had been treated, on average, 3.7 years and demonstrated efficacy in 88% of cases and reported no serious adverse effects.