Efficacy, Safety, and Indications of Exogenous Melatonin in the Autistic Population

Keywords

autism spectrum disorder - exogenous melatonin - sleep disorders

Introduction: Exogenous melatonin, a hormone related to sleep and circadian rhythm regulation, is currently being studied as a pharmacologic modality in sleep disturbances, especially in individuals diagnosed with Autism Spectrum Disorder (ASD). The incidence of sleep disorders among individuals with ASD is high, and the potential benefit of melatonin in these cases warrants further study.

Objective: This paper presents a review of the current scientific evidence regarding the use of exogenous melatonin in autistic individuals, focusing on its efficacy, safety, and dosages compared to other recommended therapies or a placebo.

Methods: This systematic narrative review followed PRISMA guidelines. The search included scientific articles published in the last 10 years in relation to the terms “Exogenous Melatonin” and “Autism,” of which 17 relevant studies were selected. Research involving animals, plants and case reports, as well as analyses conducted with fewer than twenty participants, were excluded.

Results: The review showed that intervention with melatonin has efficacy by reducing sleep onset latency and increasing the total sleep time, in addition to reducing the number of wake-up instances during the night in children with ASD. The findings suggest that melatonin is generally well-tolerated with minimal adverse effects, such as headaches, dizziness, and daytime drowsiness. There is a variability in individual responses, and long-term safety remains to be investigated.

Conclusion: Exogenous melatonin appears to be an efficacious and well-tolerated treatment method for patients with ASD-associated sleep disorders. Furthermore, research shows that the benefits of pharmacological treatment could be enhanced when in conjunction with behavioral interventions. Constant monitoring and titration in dosage are needed to maximize the therapeutic benefits derived from the medicine. Long-term safety monitoring is required to address concerns, particularly for subgroups of ASD.

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Publikationsverlauf

Artikel online veröffentlicht:
16. September 2025