The authors systematically reviewed the available scientific literature up to April 2024, including 21 clinical trials on prepubertal children. The results led to the first set of practical and evidence-based recommendations on dosage, timing, and treatment duration.

The New Guidelines

• Timing: melatonin should be taken around three hours before the desired bedtime, earlier than commonly indicated in package inserts.

• Dosage: between 2 and 4 mg per day.

• Duration: treatment should last for several weeks, not just a few days.

According to Professor Ugo Faraguna, President of Sleepacta, co-author of the study and faculty member at the University of Pisa, “the timing of administration is crucial and should ideally be personalized. In general, compared to common practice, it should be anticipated by a few hours.”

The study also highlighted that melatonin’s effectiveness is especially significant in children with neurodevelopmental disorders.

Faraguna further emphasized the need for caution: “Despite its growing use in pediatrics, there has been a lack of clear and shared recommendations. Our work fills this gap, offering a practical framework to guide both physicians and families.”

The Research Team

In addition to the Pisa and Stella Maris group, researchers from the Karolinska Institutet in Stockholm, the University of Florence, and the IRCCS Oasi Maria SS. ONLUS contributed to the study.

This work represents an important step toward a more rational and safe approach to melatonin use in pediatrics, providing concrete tools for both clinicians and families.