Ann Child Neurol.  2025 Jan;33(1):1-7. 10.26815/acn.2024.00682.

Prolonged-Release Melatonin for Sleep Disturbances in Autism Spectrum Disorder

• Vivas EA
• Ron AG
• Alguacil EG
• Gascón MB
• de Santos Moreno MT
• Cabrera ES
• de las Cuevas GRO
• Peñas JJG
• Hoyo RSd
• Insuga VS

• KMID: 2563059
• DOI: http://doi.org/10.26815/acn.2024.00682

Abstract

Purpose
Patients with autism spectrum disorder (ASD) often present with sleep disturbances. We evaluated the effectiveness of pediatric prolonged-release melatonin (PedPRM) in real clinical practice, focusing on a population of complex neuropediatric patients with highly refractory insomnia in Spain.
Methods
The patients were aged 2 to 18 years, diagnosed with ASD, had sleep maintenance insomnia and/or early morning awakening insomnia, and were refractory to prior therapy. The starting dose of PedPRM was 2 or 5 mg (increased to 10 mg, if necessary). Evaluation at 6 months consisted of a sleep diary, the Sleep Disturbance Scale for Children (SDSC), the Pediatric Daytime Sleepiness Scale (PDSS), and the Clinical Global Impression Scale of Improvement (CGI-I) and Severity (CGI-S).
Results
The median age of the 23 patients was 11.0 years, 56.5% were male, 73.9% had epilepsy, and 78.3% had intellectual disability. One patient discontinued treatment. The mean total sleep time did not change significantly. PedPRM improved sleep latency (median 30.0 to 15.0 minutes; P=0.001) and reduced the number of nocturnal awakenings (median 3.00 to 1.0; P<0.001). PedPRM significantly improved PDSS scores (14.6±4.5 to 10.4±3.5; P<0.001) and SDSC total scores (75.1±12.9 to 61.6±10.9; P<0.001). The CGI-I scale improved in 73.3% of patients; 46.7% of patients were normal, borderline, or mildly ill per CGI-S scale at the end of treatment.
Conclusion
In real clinical practice, PedPRM significantly improved sleep parameters in patients with ASD who were heavily medicated for comorbidities and were highly refractory to other insomnia treatments.

Keyword

Autism spectrum disorder; Sleep initiation and maintenance disorders; Prolonged-release melatonin; Pediatric prolonged-release melatonin; Real-world evidence