Melatonin prescription in children: a study of the POMMEs cohorts

Melatonin, approved in 2019 for the treatment of sleep disorders in children with neurodevelopmental disorders, has limited pediatric utilization data in France. We conducted a retrospective descriptive study using data from two longitudinal cohorts (POMME 2010 and POMME 2015) of children born in Haute-Garonne in 2010 and 2015, followed until 2022 (aged 12 and 7 years). Children exposed to melatonin at least once were identified. Prescribing patterns, perinatal characteristics, psychomotor development at 9 and 24 months, and concomitant psychotropic prescriptions were described. Melatonin was rarely prescribed before 2019, with use progressively increasing after melatonin (Slenyto®, RAD Neurim Pharmaceuticals EEC SARL, Paris, France) approval, particularly for continuous treatments. Most first prescriptions originated from general practitioners or pediatricians. Children receiving melatonin more frequently exhibited delayed psychomotor development from 9 months of age. Co-prescriptions with psychotropic drugs, especially hydroxyzine and methylphenidate, were common. Despite a high number of defined daily doses, prescribed amounts generally remained within the approved range. Melatonin prescribing was heterogeneous but mainly concerned children with developmental difficulties. The increasing and continuous use observed highlights the need for further research to evaluate efficacy and safety in pediatric populations. Clarification of clinical indications and a better characterization of patient profiles are essential to guide appropriate prescribing practices.