1. Prolonged-Release Melatonin for Sleep Disturbances in Autism Spectrum Disorder.
- Author
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Vivas, Eva Arias, Ron, Adrián García, Alguacil, Elena González, Gascón, Marta Bote, de Santos Moreno, María Teresa, Cabrera, Elsa Santana, de las Cuevas, Guillermo Ruiz-Ocaña, Peñas, Juan José García, Hoyo, Rafael Sánchez-del, and Insuga, Víctor Soto more...
- Subjects
SLEEP duration ,SLEEP latency ,SLEEP interruptions ,AUTISM spectrum disorders ,SLEEP disorders - 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. [ABSTRACT FROM AUTHOR] more...
- Published
- 2025
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