S06 Melatonin use in children: The promise and the peril


While there is a robust literature supporting the efficacy of melatonin in short-term pediatric clinical trials in special needs populations, many questions remain. For example, recent evidence suggests that over-the-counter preparations of melatonin may vary significantly in terms of actual concentration and may contain contaminants such as serotonin. There are concerns regarding long-term safety considerations in children, including the impact on the hypothalamic-gonadal axis and the immune system. The appropriate timing and dosage of melatonin for circadian rhythm disorders in adolescents have yet to be determined.

This symposium will address a number of fundamental issues regarding melatonin use in children, including what is currently known regarding melatonin neurophysiology in the developing brain, potential safety concerns, clinical trial data on immediate release and extended release melatonin in children with neurodevelopmental disorders, indications for use of melatonin in a variety of pediatric populations, the challenges of establishing clinical guidelines for melatonin use in the face of evolving but still somewhat limited empirical evidence, and future directions for research.

Update on the Neurophysiology of Melatonin in Children and Adolescents (Lipton)

This talk will review the neuroanatomy of the retinohypothalmic track, the concepts of entrainment, the ontogeny of sleep and circadian rhythms, and the influence of melatonin in childhood sleep.

Safety of Pharmacologic Treatment with Melatonin in Children: What We Know and Don't Know (Malow)

This presentation will present theoretical concerns and review the existing safety literature regarding short and long-term use of melatonin in children.

Clinical Trials of Melatonin in Children with Autism and Neurodevelopmental Disorders- The Latest Evidence (Gringras)

The results of 3 large randomized-controlled trials of pharmacological and non-pharmacological interventions for children with ASD and sleep problems. Findings from the MENDS immediate release melatonin study and recent studies on a novel, pediatric prolonged-release melatonin will be presented.

“Vitamin M”: Melatonin Use in the Pediatric Population (Owens)

This presentation will focus on the evidence from healthcare data bases regarding the increasing use of melatonin in pediatric populations worldwide, healthcare providers and caregivers attitudes and knowledge regarding melatonin use in infants, children, publicly available information on the relative efficacy and safety of melatonin use in pediatrics and trends in marketing of melatonin for children and adolescents to caregivers, as well as the array of available products.

Evidence Base on the Efficacy/Effectiveness of Melatonin and Development of Consensus on the Use of Melatonin in Children (Cortese)

This presentation will summarize the literature on melatonin in children across all disorders via an updated systematic review and present the 2015 consensus recommendations.

Learning Objectives

Upon completion of this CME activity, participants should be able to:

      • Describe the physiology and anatomy of melatonin and its effects on the developing sleep system
      • List the primary safety considerations in the use of melatonin in children
      • Outline current clinical trials findings regarding melatonin use in special needs pediatric populations
      • Describe the evidence supporting development of clinical guidelines for melatonin use in infants, children, and adolescents
      • List clinical research priorities in enhancing further understanding of appropriate use of melatonin in children

Target Audience

Sleep researchers interested in basic developmental physiology of melatonin, clinical sleep researchers and clinical trials specialists interested in pharmacologic treatment of pediatric insomnia, clinicians treating insomnia in the pediatric population, and policy makers interested in developing clinical guidelines for use of medication in children and adolescents


Judith Owens (United States)

Update on the neurophysiology of melatonin in children and adolescents

Jonathan Lipton (United States)

Safety of pharmacologic treatment with melatonin in children: What we know and do not know

Beth Malow (United States)

Clinical trials of melatonin in children with autism and neurodevelopmental disorders: The latest evidence 

Paul Gringras (United Kingdom)

"Vitamin M": Melatonin use in the pediatric population

Judith Owens (United States)

Evidence base on the efficacy/effectiveness of melatonin and development of consensus on the use of melatonin

Samuele Cortese (United Kingdom)

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