Prolonged-Release Melatonin for Sleep Disturbances in Autism Spectrum Disorder

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...

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Main Authors: Eva Arias Vivas, 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
Format: Article
Language:English
Published: Korean Child Neurology Society 2025-01-01
Series:Annals of Child Neurology
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Online Access:http://annchildneurol.org/upload/pdf/acn-2024-00682.pdf
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author Eva Arias Vivas
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_facet Eva Arias Vivas
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_sort Eva Arias Vivas
collection DOAJ
description 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.
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2635-9103
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series Annals of Child Neurology
spelling doaj-art-2075f1dda38740daa2835123d2490d432024-12-31T04:00:30ZengKorean Child Neurology SocietyAnnals of Child Neurology2635-909X2635-91032025-01-013311710.26815/acn.2024.006821382Prolonged-Release Melatonin for Sleep Disturbances in Autism Spectrum DisorderEva Arias Vivas0Adrián García Ron1Elena González Alguacil2Marta Bote Gascón3María Teresa de Santos Moreno4Elsa Santana Cabrera5Guillermo Ruiz-Ocaña de las Cuevas6Juan José García Peñas7Rafael Sánchez-del Hoyo8Víctor Soto Insuga9 Department of Pediatrics, Hospital Clínico San Carlos, Madrid, Spain Department of Pediatrics, Hospital Clínico San Carlos, Madrid, Spain Department of Neuropediatrics, Hospital Niño Jesús, Madrid, Spain Department of Pediatrics, Hospital Clínico San Carlos, Madrid, Spain Department of Pediatrics, Hospital Clínico San Carlos, Madrid, Spain Department of Pediatrics, Hospital Clínico San Carlos, Madrid, Spain Department of Pediatrics, Hospital Clínico San Carlos, Madrid, Spain Department of Neuropediatrics, Hospital Niño Jesús, Madrid, Spain Research Methodology Support Unit, Hospital Clínico San Carlos, IdISCC, Madrid, Spain Department of Neuropediatrics, Hospital Niño Jesús, Madrid, SpainPurpose 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.http://annchildneurol.org/upload/pdf/acn-2024-00682.pdfsleep initiation and maintenance disordersautism spectrum disordermelatoninsleep latencyspainsleep
spellingShingle Eva Arias Vivas
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
Prolonged-Release Melatonin for Sleep Disturbances in Autism Spectrum Disorder
Annals of Child Neurology
sleep initiation and maintenance disorders
autism spectrum disorder
melatonin
sleep latency
spain
sleep
title Prolonged-Release Melatonin for Sleep Disturbances in Autism Spectrum Disorder
title_full Prolonged-Release Melatonin for Sleep Disturbances in Autism Spectrum Disorder
title_fullStr Prolonged-Release Melatonin for Sleep Disturbances in Autism Spectrum Disorder
title_full_unstemmed Prolonged-Release Melatonin for Sleep Disturbances in Autism Spectrum Disorder
title_short Prolonged-Release Melatonin for Sleep Disturbances in Autism Spectrum Disorder
title_sort prolonged release melatonin for sleep disturbances in autism spectrum disorder
topic sleep initiation and maintenance disorders
autism spectrum disorder
melatonin
sleep latency
spain
sleep
url http://annchildneurol.org/upload/pdf/acn-2024-00682.pdf
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