Melatonin use in infants and toddlers.

Background Melatonin use in the pediatric population is on the rise in the United States, where it is available as an over-the-counter and online supplement. There are no data regarding the safety and efficacy of melatonin in children less than 2 years old. The aim of this study was to examine various aspects of melatonin use by caregivers of infants and toddlers in the US. Methods Caregiver users of the Nanit baby monitoring system with a child aged 0-36 months were invited to complete an online survey regarding melatonin use, sources of information/recommendations about melatonin, formulations used and reasons for administering melatonin to their child. Participants also completed the Brief Infant Sleep Questionnaire-Revised (BISQ-R). Results A total of 3063 caregivers (1.93%) responded to the survey, of whom 1.7% had ever used melatonin for their child. About half of those caregivers had received a recommendation for melatonin from a source other than a healthcare professional. Caregiver perception of 'sleep as a problem' as assessed by the BISQ-R was not significantly different between those who had or had not used melatonin for their child, and reasons for use included non-supported indications such as sleeping later or promoting "more restful and better sleep". Conclusions The results of this study support mounting concerns regarding the widespread use of melatonin in the US pediatric population, especially given the lack of regulatory oversight and the documented inaccuracy of label claims versus actual melatonin content.