Melatonin Treatment and Adequate Sleep Hygiene Interventions in Children with Autism Spectrum Disorder: A Randomized Controlled Trial

Hayashi, Masaharu; Mishima, Kazuo; Fukumizu, Michio; Takahashi, Hiroyuki; Ishikawa, Yuko; Hamada, Izumi; Sugioka, Hideyuki; Yotsuya, Osamu; Yamashita, Yushiro

doi:10.1007/s10803-021-05139-w

Cited by 17 publications

(43 citation statements)

References 35 publications

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“…All 3 SRs [14][15][16] and 1 primary clinical study 17 reported both efficacy and safety outcomes, while the other primary clinical study 18 reported only efficacy outcomes. The efficacy outcomes comprised sleep onset latency (SOL; defined as the length of time in bed from when the lights are turned off until the onset of any sleep stage), sleep onset time (SOT; defined as the clock time at night when the patient goes into any sleep stage from wakefulness), total sleep time (TST; defined as the length of time between sleep onset and wake-up time), sleep efficiency (defined as the ratio of TST to total time in bed), number of wakenings after sleep onset, wake-up time after sleep onset (defined as total time staying awake between the time of falling asleep and wakening time), light-time off, dim light melatonin onset (DLMO; defined as the clock time between 7:00 p.m. and 11:00 p.m. when endogenous melatonin reaches 4 pg/mL in the saliva), and child's behaviour.…”

Section: Discussionmentioning

confidence: 99%

“…Both included primary clinical studies were RCTs, 17,18 published in 2021 17 and 2017. 18 Both RCTs 17,18 were parallel and double-blinded. One RCT was multicentric, 17 while the other was monocentric.…”

Section: Methodsmentioning

confidence: 99%

“…18 Both RCTs 17,18 were parallel and double-blinded. One RCT was multicentric, 17 while the other was monocentric. 18 One RCT 17 reported a sample size calculation and analyzed the data using the intention-to-treat (ITT) approach, while the other 18 did not.…”

Section: Methodsmentioning

confidence: 99%

“…All included SRs, [14][15][16] and the primary clinical studies 17,18 compared melatonin with placebo. Melatonin dosages (0.5 mg to 9 mg per day), duration of treatment (1 week to 13 weeks), regimens (fast release, sustained release) and administration times (at 4:30 p.m. to 9:00 p.m. or 20 minutes to 45 minutes before bedtime) varied across studies.…”

Section: Interventions and Comparatorsmentioning

confidence: 99%

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Melatonin for the Treatment of Insomnia in Children and Adolescents

Tran¹,

Mahood²

2022

cjht

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There is some evidence of benefit of melatonin compared with placebo for the short-term treatment of insomnia in children and adolescents with neurodisabilities. The short-term safety profile of melatonin suggested that it was well-tolerated, although some severe adverse events may occur. There was a lack of long-term safety data. The American Academy of Neurology guideline recommends high-grade melatonin should be prescribed for treatment of sleep disturbance in children and adolescents with autism spectrum disorder if first-line treatment with behavioural strategies is not helpful. Evidence comparing the clinical effectiveness of melatonin with prescription sedatives for the treatment of insomnia in children and adolescents was not identified. No evidence was found regarding the cost-effectiveness of melatonin compared with placebo or prescription sedatives for the treatment of insomnia in children and adolescents.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Interventions and Comparatorsmentioning

confidence: 99%

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Melatonin for the Treatment of Insomnia in Children and Adolescents

Tran¹,

Mahood²

2022

cjht

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“…Also, a decrease in the levels of melatonin as well as decreased melatonin synthesis was repeatedly reported in ASD individuals [ 97 , 103 , 104 ]. The therapeutic benefits of melatonin treatment in ASD patients range from improving the sleep latency and sleep quality to improving the behavioral impairements [ 105 – 107 ]. A randomized clinical trial found aglomatine, an analogue of melatonin to be effective in the treatment of insomnia and sleep problems in ASD patients [ 108 ].…”

Section: Circadian Dysfunction Mtor and Asdmentioning

confidence: 99%

The trilateral interactions between mammalian target of rapamycin (mTOR) signaling, the circadian clock, and psychiatric disorders: an emerging model

2022

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Circadian (~24 h) rhythms in physiology and behavior are evolutionarily conserved and found in almost all living organisms. The rhythms are endogenously driven by daily oscillatory activities of so-called “clock genes/proteins”, which are widely distributed throughout the mammalian brain. Mammalian (mechanistic) target of rapamycin (mTOR) signaling is a fundamental intracellular signal transduction cascade that controls important neuronal processes including neurodevelopment, synaptic plasticity, metabolism, and aging. Dysregulation of the mTOR pathway is associated with psychiatric disorders including autism spectrum disorders (ASD) and mood disorders (MD), in which patients often exhibit disrupted daily physiological rhythms and abnormal circadian gene expression in the brain. Recent work has found that the activities of mTOR signaling are temporally controlled by the circadian clock and exhibit robust circadian oscillations in multiple systems. In the meantime, mTOR signaling regulates fundamental properties of the central and peripheral circadian clocks, including period length, entrainment, and synchronization. Whereas the underlying mechanisms remain to be fully elucidated, increasing clinical and preclinical evidence support significant crosstalk between mTOR signaling, the circadian clock, and psychiatric disorders. Here, we review recent progress in understanding the trilateral interactions and propose an “interaction triangle” model between mTOR signaling, the circadian clock, and psychiatric disorders (focusing on ASD and MD).

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Melatonin bei Schlafstörungen im Kindes- und Jugendalter

Paditz

2023

Monatsschr Kinderheilkd

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Zusammenfassung Stand der Forschung Bisher liegen 33 randomisierte kontrollierte Studien (RCT) unterschiedlicher Qualität zu den Effekten oraler Melatoningaben im Vergleich zu Placebo bei Kindern und Jugendlichen im Alter von 2 bis 18 Jahren vor; diese werden in der vorliegenden Übersicht in Bezug auf Diagnosegruppen vorgestellt. Zusätzlich existieren zu einigen Erkrankungen Fallbeschreibungen oder -serien. Hinweise zur Verordnung Aus diesen klinischen Daten werden orientierende Empfehlungen zur Dosierung, zum Applikationszeitpunkt und zur Behandlungsdauer abgeleitet. Auf den aktuellen Stand der Zulassungen in Deutschland, Österreich und der Schweiz (D-A-CH) wird hingewiesen. Nebenwirkungen und Komplikationen Möglichst niedrige Dosierungen und mehrwöchige Auslassversuche werden empfohlen, damit ein Resetting der Melatoninrezeptoren erfolgen kann. Bisher sind keine ausreichenden Daten zu Langzeiteffekten, die sich u. a. auch auf die Auslösung der Pubertät beziehen könnten, verfügbar. Des Weiteren wurde kürzlich über Todesfälle bei Säuglingen und Kleinkindern im zeitlichen Zusammenhang mit erheblichen Melatoninüberdosierungen berichtet. Differenzialdiagnostik vorab Vor Behandlungsbeginn sollten eine ausführliche Anamnese und ein neurologischer Status erhoben werden (insbesondere bezüglich Sehstörungen, Kopfschmerzen, Schwindel, Polyurie, Polydipsie), damit klinisch bedeutsame Pinealiszysten, Pinealistumoren und supraselläre Tumoren nicht übersehen werden.

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Melatonin Treatment and Adequate Sleep Hygiene Interventions in Children with Autism Spectrum Disorder: A Randomized Controlled Trial

Cited by 17 publications

References 35 publications

Melatonin for the Treatment of Insomnia in Children and Adolescents

Melatonin for the Treatment of Insomnia in Children and Adolescents

The trilateral interactions between mammalian target of rapamycin (mTOR) signaling, the circadian clock, and psychiatric disorders: an emerging model

Melatonin bei Schlafstörungen im Kindes- und Jugendalter

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