Introduction
Sleep disturbances affect up to 80% of children with Autism Spectrum Disorder (ASD), often presenting as difficulty falling or staying asleep, fragmented sleep, and reduced total sleep time. These problems exacerbate behavioral dysregulation, cognitive impairment, and caregiver stress. Conventional therapies such as melatonin or sedatives offer limited and inconsistent benefit. Medicinal cannabis; particularly formulations containing cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC); has emerged as a potential alternative for improving sleep and quality of life in this population. This study evaluates the 18-month efficacy and safety of individualized medicinal cannabis treatment for sleep disturbances in children with ASD.

Materials and Methods
This longitudinal observational study followed 56 pediatric patients (ages 3–17 years) with a confirmed ASD diagnosis. Participants received cannabis formulations with varying CBD:THC ratios (1:1, 3:1, 4:1, 20:1), using tinctures or gummies. Doses ranged from THC 1.25–5 mg twice daily, adjusted based on clinical response and tolerance. Sleep data were collected at baseline, 3 months, and 18 months using caregiver-reported measures and validated sleep questionnaires. Primary outcomes included total sleep time (TST), sleep onset and maintenance, and overall quality of sleep (QoS). Secondary outcomes assessed quality of life (QoL) for children and caregivers, side effects, and treatment tolerance. Paired t-tests and repeated-measures ANOVA were used for analysis.

Results
After 18 months, mean total sleep time increased by 1.1 hours across the cohort (p = 0.0001) and by 1.75 hours among short sleepers (<6 hours baseline; p = 8×10⁻⁶). Sleep onset insomnia improved in 74% and sleep maintenance insomnia in 76% of patients. Overall, 71% reported better quality of sleep. Child QoL improved in 88% and caregiver QoL in 89% of cases. Side effects; primarily mild irritability, appetite increase, or transient drowsiness; were reported by fewer than 10% and typically resolved to half within two weeks. No severe adverse events occurred.

Conclusions
Long-term, tailored use of medicinal cannabis resulted in sustained sleep improvements and enhanced quality of life for both children and caregivers, with a favorable safety profile. While variability in formulations and co-medications remain limitations, these results support medicinal cannabis as a promising adjunct for pediatric sleep management in ASD. Future research should refine optimal cannabinoid ratios, dosing regimens, and biomarker integration (EEG, PSG, endocannabinoid levels) to guide evidence-based clinical use.

Acknowledgments
The author thanks the participating families, clinical staff, and student collaborators for their contributions. This research was conducted independently, without external funding, within a pediatric neurology sleep practice.

Learning Objectives:

• Assess long-term sleep outcomes of medicinal cannabis in children with autism

• Review safety, tolerance, and caregiver-reported effects over 18 months

• Explore individualized cannabinoid use in pediatric sleep management