Considerations regarding melatonin for sleep in children

Pros	Cons
Empiric evidence for efficacy in improving sleep onset, largely in children with neurodevelopmental disorders; fewer studies in typically developing children Minimal effects on sleep architecture Acceptability to caregivers Generally low side effect profile Widely available Low cost Low-dose and liquid preparations available	Long-term side effects uncertain (eg, pubertal development) Few or no studies in psychiatric populations (eg, anxiety, mood disorders) Dosing timing is important and depends on clinical use (several hours before bedtime for circadian rhythm effects or shortly before bedtime for sleep-onset insomnia) Studies of extended-release formulation (prescription only, not available in United States) suggest efficacy for sleep-maintenance insomnia in autism Reliability of over-the-counter preparations highly variable; products with a third-party verification seal (eg, US Pharmacopeia [USP] Verified Mark) may provide a more reliable preparation
Bottom line – Consider short-term use for children with sleep-onset insomnia, in combination with behavioral interventions. Most empiric evidence is in neurodiverse children (eg, autism). May also be used in patients (typically adolescents) with circadian phase delay.

Courtesy of Judith A Owens, MD, MPH.

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