Safe and Effective Dosing of Over-The-Counter Melatonin use for Sleep Disturbances in Children with Autism: A Literature Review

With the increasing prevalence of autism, it is important to identify if the over-the-counter (OTC) melatonin use for sleep disorders in autistic children is safe and effective. Since there are no FDA-approved medications for children with insomnia, this literature review aims to cast helpful insight for caregivers and physicians concerning the safe and effective use of OTC melatonin in autistic children for sleep disturbance relief. PubMed, International Pharmaceutical Abstracts (IPA), and Google Scholar were utilized in the search for studies for this literature review. Two randomized placebo-controlled crossover trials, one randomized placebo-controlled clinical trial, and two open-label trials were looked at for dosage strength, efficacy, and safety. From these trials, melatonin use seems effective and safe within the dosing ranges of 1mg to 10mg. Titration may be needed in some children depending upon if they are a slow or fast metabolizer of melatonin. Improvements in sleep and in behavior were documented. Therefore, melatonin is seemingly safe and effective in helping autistic children with sleep disturbances by helping them go to sleep faster and stay asleep longer, thus giving them a better night’s rest. Children Sleep Habits Questionnaire