Vol. 8, Issue 1, Part A (2026)

Background: Sleep disturbances are highly prevalent among children with autism spectrum disorder (ASD) and are associated with worsening behavioral problems, impaired cognitive functioning, and reduced family quality of life. Alterations in circadian rhythm and abnormal melatonin secretion have been consistently reported in this population. Melatonin supplementation has emerged as a promising therapeutic intervention; however, evidence from large multi-center clinical studies examining both sleep and cognitive outcomes remains limited.

Objective: To evaluate the effectiveness and safety of melatonin therapy on sleep disturbances and cognitive function in children with ASD through a multi-center clinical study involving 120 participants.

Methods: This prospective, multi-center clinical study enrolled 120 children aged 4-12 years diagnosed with ASD and presenting with clinically significant sleep disturbances. Participants received nightly oral melatonin (3-6 mg) for 12 weeks. Primary sleep outcomes included sleep onset latency, total sleep time, and night awakenings, measured using actigraphy and parent-reported sleep diaries. Secondary outcomes included cognitive function assessments focusing on attention, executive functioning, and adaptive behavior. Safety and adverse events were monitored throughout the study.

Results: Melatonin therapy resulted in a statistically significant reduction in mean sleep onset latency (−34.8±12.6 minutes, p<0.001) and an increase in total sleep time (+68.2±21.4 minutes, p<0.001). Night awakenings decreased significantly across centers. Cognitive assessments demonstrated modest but significant improvements in attention and executive functioning scores (p<0.05). Melatonin was well tolerated, with mild adverse effects reported in 8.3% of participants.

Conclusion: Melatonin therapy is an effective and safe intervention for improving sleep disturbances in children with ASD and may contribute to modest improvements in cognitive functioning. Incorporating melatonin into comprehensive ASD management plans may enhance overall functioning and quality of life.