Why is melatonin (N-acetyl-5-methoxytryptamine) contraindicated in infants?

Melatonin Safety Concerns in Infants

Melatonin is not recommended for use in infants due to potential effects on growth hormone regulation, reproductive development, and lack of safety data in this vulnerable population. 1, 2

Safety Concerns for Melatonin Use in Infants

Physiological Concerns

• Melatonin is a hormone that has profound effects beyond sleep regulation, including impacts on:
  • Reproductive system development 2
  • Cardiovascular system 2
  • Immune system function 2
  • Metabolic processes 2

Regulatory and Research Gaps

• Melatonin is not registered for use in infants anywhere in the world 2
• It has not undergone formal safety testing expected for pediatric medications, especially regarding long-term safety 2
• There is a complete lack of safety and efficacy data for children under 2 years of age 3

Documented Risks

• Pediatric melatonin ingestions have increased 530% over a recent 10-year period (2012-2021) 4
• Melatonin became the most frequently ingested substance among children reported to poison control centers in 2020 4
• Serious outcomes including hospitalizations have increased, primarily related to unintentional ingestions in children under 5 years 4
• Five children required mechanical ventilation and two deaths were reported in a 10-year surveillance period 4

Concerning Trends in Infant Melatonin Use

• About half of caregivers who administered melatonin to infants and toddlers received recommendations from sources other than healthcare professionals 3
• Parents often use melatonin for unsupported indications such as promoting "more restful sleep" rather than for specific sleep disorders 3
• There is significant variability between labeled and actual melatonin content in over-the-counter supplements, creating dosing risks 3

Appropriate Sleep Management for Infants

Instead of melatonin, the following approaches are recommended for infant sleep issues:

• Establish consistent sleep-wake schedules 1
• Create a dark, quiet, and cool bedroom environment 1
• Remove electronic devices from the sleep environment 1
• Implement proper sleep hygiene practices appropriate for infants 5
• Consider non-pharmacological approaches such as behavioral interventions 5

Important Cautions

• The American Academy of Sleep Medicine recommends consultation with a pediatric sleep specialist rather than self-administration of melatonin for children 1
• If sleep problems persist in infants, evaluation for underlying medical conditions should be considered before any pharmacological intervention

Melatonin should be kept out of reach of children, as the increasing prevalence of pediatric melatonin ingestions represents a growing public health concern 4.