Long-Term Efficacy and Safety of Pediatric Prolonged-Release Melatonin for Insomnia in Children with Autism Spectrum Disorder

Maras, Athanasios; Schröder, Carmen; Malow, Beth A.; Findling, Robert L.; Breddy, John; Nir, Tali; Shahmoon, Shiri; Zisapel, Nava; Gringras, Paul

doi:10.1089/cap.2018.0020

Cited by 121 publications

(104 citation statements)

References 45 publications

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“…It was proved that autonomic nervous system paths are altered during poor sleep patterns, thus introducing an imbalanced psychological condition [34]. Individuals with ASD often experience sleep disorders [35]. Insomnia in autistic children and adolescents is challenging to their families and has been associated with increased maternal distress and parental sleep disruption as well as poor caregiver's quality of life [35].…”

Section: Discussionmentioning

confidence: 99%

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The Prevalence of Insomnia and the Link between Iron Metabolism Genes Polymorphisms, TF rs1049296 C>T, TF rs3811647 G>A, TFR rs7385804 A>C, HAMP rs10421768 A>G and Sleep Disorders in Polish Individuals with ASD

Skonieczna-Żydecka

Jamioł-Milc

Borecki

et al. 2020

IJERPH

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Iron deficiency have been found to be linked to sleep disorders. Both genetic and environmental factors are risk factors for skewed iron metabolism, thus sleep disruptions in autism spectrum disorders (ASD). The aim of our study was to assess the prevalence of single nucleotide polymorphisms (SNPs) within transferrin gene (TF) rs1049296 C>T, rs3811647 G>A, transferrin receptor gene (TFR) rs7385804 A>C, and hepcidin antimicrobial peptide gene (HAMP) rs10421768 A>G in Polish individuals with ASD and their impact on sleep pattern. There were 61 Caucasian participants with ASD and 57 non-ASD controls enrolled. Genotypes were determined by real-time PCR using TaqMan SNP assays. The Athens Insomnia Scale (AIS) was used to identify sleep disruptions. There were 32 cases (57.14%) with insomnia identified. In the ASD group, the defined counts of genotypes were as follows: TF rs1049296, C/C n = 41 and C/T n = 20; TF rs3811647, G/G n = 22, G/A n = 34, and A/A n = 5; TFR rs7385804, A/A n = 22, A/C n = 29, and C/C n = 10; and HAMP rs10421768, A/A n = 34, A/G n = 23, and G/G n = 4. There were no homozygous carriers of the TF rs1049296 C>T minor allele in the ASD group. All analyzed SNPs were not found to be linked to insomnia. The investigated polymorphisms are not predictors of sleep disorders in the analyzed cohort of individuals with ASD.

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Section: Discussionmentioning

confidence: 99%

“…Individuals with ASD often experience sleep disorders [35]. Insomnia in autistic children and adolescents is challenging to their families and has been associated with increased maternal distress and parental sleep disruption as well as poor caregiver's quality of life [35].…”

Section: Discussionmentioning

confidence: 99%

The Prevalence of Insomnia and the Link between Iron Metabolism Genes Polymorphisms, TF rs1049296 C>T, TF rs3811647 G>A, TFR rs7385804 A>C, HAMP rs10421768 A>G and Sleep Disorders in Polish Individuals with ASD

Skonieczna-Żydecka

Jamioł-Milc

Borecki

et al. 2020

IJERPH

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“…[59][60][61] While prescription medication has not been approved, evidence form published studies in the past 15 years supports the overall efficacy and tolerability of melatonin for insomnia in children. [62][63][64][65][66] Melatonin is considered particularly beneficial for insomnia in children with autism 67,68 or special needs. 69,70…”

Section: Treatmentmentioning

confidence: 99%

Pediatric Insomnia: Update and Future Directions

Medalie

Gozal

2018

JCS

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Throughout their childhood, pediatric insomnia impacts approximately 25% of all children in the general population. Although it can occur as an isolated condition, it commonly associates with other comorbidities, such as autism, developmental delay, and psychiatric disorders. Careful and detailed history is essential, and sleep logs and actigraphy are useful tools in the assessment and diagnosis of pediatric insomnia. However, polysomnography is usually not warranted in the assessment of pediatric insomnia unless underlying medically-based sleep symptoms are concurrently identified and justify such test. In the majority of cases, behavioral interventions are the recommended approach for treatment. Despite the fact that many pharmacological approaches are used for child insomnia off-label, there are currently no FDA (Food and Drug Administration) approved medications for the management of pediatric insomnia. The high prevalence of pediatric insomnia, coupled with the low number of providers, who are formally trained in behavioral treatment for this prevalent condition, highlights the urgent need for improving primary care practitioner awareness, while expanding alternative routes to access to care, such as interactive virtual technology-based treatments, parent education and manuals, along with ongoing efforts to increase professional training opportunities.

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“…За результатами 19 рандомізованих контрольованих досліджень встановлено, що мелатонін у середньому на 28 хвилин скорочував час засинання, на 33 хвилини подовжував тривалість сну, але не впливав на кількість пробуджень за ніч. Препарат у цілому непогано переносився [21], але покращення сну було найбільшим у дітей з аутизмом [1,32,33] або іншими порушеннями розвитку нервової системи, тоді як у дітей і підлітків із хронічною пресомнією ефект був незначний.…”

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Безопасность Применения Нейроадаптогенов Когивис И Силента В Педиатрической Практике

Кhaitovych¹

2021

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За последнюю декаду существенно возросла распространенность психовегетативных расстройств у детей. Тревожность, инсомния нарушают вегетативную регуляцию, вызывают частые головные боли, колебания артериального давления, ухудшение внимания, памяти, снижают качество жизни ребенка и семьи. Рассмотрены данные доказательной медицины в аспекте безопасности применения агонистов рецепторов гамма-аминомасляной кислоты (бензодиазепинов, препаратов Z-группы), мелатонина; препаратов, используемых для лечения детей с синдромом дефицита внимания с гиперактивностью (стимулирующих и нестимулирующих) и др. Использование данных лекарственных средств часто сопровождается побочными эффектами, что делает невозможным их рутинное применение. Альтернативой является использование комбинированных лекарственных средств с синергическим действием, что позволяет минимизировать их побочные эффекты. Обоснована целесообразность применения комплексных препаратов Когивис и Силента для нейроадаптации детей

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Long-Term Efficacy and Safety of Pediatric Prolonged-Release Melatonin for Insomnia in Children with Autism Spectrum Disorder

Abstract: PedPRM, an easily swallowed formulation shown to be efficacious versus placebo, is an efficacious and safe option for long-term treatment (up to 52 weeks reported here) of children with ASD and NGD who suffer from insomnia and subsequently improves caregivers' quality of life.

Cited by 121 publications

References 45 publications

The Prevalence of Insomnia and the Link between Iron Metabolism Genes Polymorphisms, TF rs1049296 C>T, TF rs3811647 G>A, TFR rs7385804 A>C, HAMP rs10421768 A>G and Sleep Disorders in Polish Individuals with ASD

The Prevalence of Insomnia and the Link between Iron Metabolism Genes Polymorphisms, TF rs1049296 C>T, TF rs3811647 G>A, TFR rs7385804 A>C, HAMP rs10421768 A>G and Sleep Disorders in Polish Individuals with ASD

Pediatric Insomnia: Update and Future Directions

Безопасность Применения Нейроадаптогенов Когивис И Силента В Педиатрической Практике

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