What is the safe dose of melatonin (melatonin) for pediatric patients?

From the Guidelines

The safe dose of melatonin for pediatrics is 0.05-0.15 mg/kg, with mean doses ranging from 1.6 to 4.4 mg, taken 1.5-2.0 hours prior to habitual bedtime, as supported by a randomized, placebo-controlled double-blinded study 1. When considering the use of melatonin in children, it's essential to weigh the potential benefits against the risks, prioritizing morbidity, mortality, and quality of life as outcomes.

Key Considerations

• The American Academy of Sleep Medicine clinical practice guideline suggests that strategically timed melatonin is effective for children and adolescents with delayed sleep-wake phase disorder (DSWPD) and no comorbidities 1.
• The dose of melatonin should be individualized, starting with the lowest possible dose and increasing gradually if needed, with a maximum dose of 6 mg, as suggested by a practice pathway for the identification, evaluation, and management of insomnia in children and adolescents with autism spectrum disorders 1.
• Melatonin should be used short-term (less than 3 months) for sleep onset difficulties rather than as a long-term solution.
• Side effects are generally mild but may include morning drowsiness, headache, dizziness, or nausea.
• It's crucial to address underlying sleep hygiene issues and establish consistent bedtime routines before turning to melatonin.
• Always purchase melatonin from reputable sources, as supplements aren't strictly regulated, and actual content may vary from labeled amounts.

Age-Specific Guidance

• For children under 2 years, consult a pediatrician before use.
• Children aged 2-5 years may take 0.5-1 mg, children 6-12 years may take 1-3 mg, and adolescents 13-18 years may take 3-6 mg, as a general guideline.
• However, the most recent and highest-quality study 1 suggests using 0.05-0.15 mg/kg, with mean doses ranging from 1.6 to 4.4 mg, for children and adolescents with DSWPD and no comorbidities.

From the Research

Melatonin Dosage for Pediatrics

• The safe dose of melatonin for pediatrics is not clearly established, as there are limited clinical guidelines available for healthcare practitioners 2.
• A study on melatonin administration patterns for pediatric inpatients found that the average dosing varied by age, with the most frequent dose being 5 mg (28.3%), predominantly in patients ≥12 years of age 3.
• However, there is no consensus on the appropriate dosage for children, and further research is needed to determine best practices for melatonin prescribing for hospitalized children 3.
• Another study found that melatonin use in infants and toddlers is on the rise, but there are no data regarding the safety and efficacy of melatonin in children less than 2 years old 4.

Considerations for Melatonin Use in Pediatrics

• Melatonin is widely used for sleep regulation in children, but its use is not without risks, and there are concerns about its safety and efficacy in the pediatric population 5.
• The lack of regulatory oversight and the documented inaccuracy of label claims versus actual melatonin content are also concerns 4.
• A study evaluating the discrepancy in evidence based on country and regulations regarding production found that evidence supporting the use of US formulations of melatonin in the otherwise healthy pediatric population is non-existent 6.
• Therefore, melatonin should be used sparingly in the otherwise healthy pediatric population, if it is used at all 6.