Prolonged-Release Melatonin for Sleep Disturbances in Autism Spectrum Disorder
- Author:
Eva Arias VIVAS
1
;
Adrián García RON
;
Elena González ALGUACIL
;
Marta Bote GASCÓN
;
María Teresa DE SANTOS MORENO
;
Elsa Santana CABRERA
;
Guillermo Ruiz-Ocaña DE LAS CUEVAS
;
Juan José García PEÑAS
;
Rafael Sánchez-del HOYO
;
Víctor Soto INSUGA
Author Information
- Publication Type:Original article
- From: Annals of Child Neurology 2025;33(1):1-7
- CountryRepublic of Korea
- Language:English
-
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.
