Dados do Trabalho


Título

EFICACY OF MELATONIN USE IN THE TREATMENT OF INSOMNIA IN THE PEDIATRIC POPULATION WITH AUTISM SPECTRUM DISORDER (ASD): RANDOMIZED CLINICAL TRIALS OVERVIEW

Introdução

Autism Spectrum Disorder (ASD) is a neurodevelopmental condition that affects communication, behavior and social interaction. Among the associated comorbidities, insomnia is highly prevalent, affecting up to 80% of children with this disorder. Difficulty in initiating and maintaining sleep exacerbates ASD symptoms, negatively impacting children's behavior and daily functioning.
Pediatric extended-release melatonin (PedPRM), a natural hormone that regulates the sleep-wake cycle, has been investigated as a potential intervention to improve sleep quality in these populations. This systematic review evaluates the efficacy and safety of PedPRM for the treatment of insomnia in children with ASD.

Objetivo

The present study aims to summarize the evidence from clinical trials regarding the effectiveness of melatonin in treating insomnia in patients with ASD.

Método

Randomized clinical trials evaluated the efficacy and safety of pediatric extended-release melatonin in children with ASD.
All RCTs in humans referring to the effectiveness of melatonin in the treatment of insomnia included in the selected databases were part of the search strategy.
The search was conducted in relevant databases to identify clinical studies on the use of PedPRM in children with ASD. The PubMed, Cochrane Library, and EMBASE databases were used, employing the descriptors: "Autism disorder," "Insomnia," and "Melatonin," and selecting all articles regardless of language or date.
Selection Process:The studies were selected by two independent reviewers and filtered according to the inclusion and exclusion criteria, resulting in a total of six RCTs that met the criteria.

Resultados

The six studies reviewed show the effectiveness of melatonin in treating insomnia in children with ASD and other neurodevelopmental disabilities. In several clinical studies, melatonin has been shown to be effective in improving critical sleep parameters, such as total sleep time, latency and nighttime awakenings.

Conclusão

The studies inclued in this systematic review provide consistent evidence that pediatric prolonged-release melatonin (PedPRM) is effective and safe for treating insomnia in children with autism spectrum disorder (ASD) and neurogenetic disorders (NGD). They suggesting that melatonin can be an effective intervention to regulate sleep in this population and improve the quality of life of patients and their caregivers, without significant adverse effects.

Referências

1) Gringras P, Nir T, Breddy J, Frydman-Marom A, Findling RL. Efficacy and Safety of Pediatric Prolonged-Release Melatonin for Insomnia in Children With Autism Spectrum Disorder. J Am Acad Child Adolesc Psychiatry. 2017 Nov;56(11):948-957.e4. doi: 10.1016/j.jaac.2017.09.414. Epub 2017 Sep 19. PMID: 29096777.
2) Maras A, Schroder CM, Malow BA, Findling RL, Breddy J, Nir T, Shahmoon S, Zisapel N, Gringras P. Long-Term Efficacy and Safety of Pediatric Prolonged-Release Melatonin for Insomnia in Children with Autism Spectrum Disorder. J Child Adolesc Psychopharmacol. 2018 Dec;28(10):699-710. doi: 10.1089/cap.2018.0020. Epub 2018 Oct 11. PMID: 30132686; PMCID: PMC6306655.
3) Goldman SE, Adkins KW, Calcutt MW, Carter MD, Goodpaster RL, Wang L, Shi Y, Burgess HJ, Hachey DL, Malow BA. Melatonin in children with autism spectrum disorders: endogenous and pharmacokinetic profiles in relation to sleep. J Autism Dev Disord. 2014 Oct;44(10):2525-35. doi: 10.1007/s10803-014-2123-9. PMID: 24752680; PMCID: PMC4372534.
4) Schroder CM, Malow BA, Maras A, Melmed RD, Findling RL, Breddy J, Nir T, Shahmoon S, Zisapel N, Gringras P. Pediatric Prolonged-Release Melatonin for Sleep in Children with Autism Spectrum Disorder: Impact on Child Behavior and Caregiver's Quality of Life. J Autism Dev Disord. 2019 Aug;49(8):3218-3230. doi: 10.1007/s10803-019-04046-5. PMID: 31079275; PMCID: PMC6647439.
5) Malow B, Adkins KW, McGrew SG, Wang L, Goldman SE, Fawkes D, Burnette C. Melatonin for sleep in children with autism: a controlled trial examining dose, tolerability, and outcomes. J Autism Dev Disord. 2012 Aug;42(8):1729-37; author reply 1738. doi: 10.1007/s10803-011-1418-3. PMID: 22160300; PMCID: PMC3368078.
6) Wasdell MB, Jan JE, Bomben MM, Freeman RD, Rietveld WJ, Tai J, Hamilton D, Weiss MD. A randomized, placebo-controlled trial of controlled release melatonin treatment of delayed sleep phase syndrome and impaired sleep maintenance in children with neurodevelopmental disabilities. J Pineal Res. 2008 Jan;44(1):57-64. doi: 10.1111/j.1600-079X.2007.00528.x. PMID: 18078449.

Palavras Chave

Autism disorder; Insomnia; Melatonin

Área

Transtornos do sono

Autores

EDUARDA MENDONÇA DERCY, ANDRE LUIZ MENDES SILVA, FABIANO LESSA MUNIZ