An Open-Label Study of Controlled-Release Melatonin in Treatment of Sleep Disorders in Children with Autism

  title={An Open-Label Study of Controlled-Release Melatonin in Treatment of Sleep Disorders in Children with Autism},
  author={Flavia Giannotti and Flavia Cortesi and Antonella Cerquiglini and Paola Bernabei},
  journal={Journal of Autism and Developmental Disorders},
Long-term effectiveness of controlled-release melatonin in 25 children, aged 2.6–9.6 years with autism without other coexistent pathologies was evaluated openly. Sleep patterns were studied using Children’s Sleep Habits Questionnaire (CSHQ) and sleep diaries at baseline, after 1–3–6 months melatonin treatment and 1 month after discontinuation. Sleep diary and CSHQ showed a more problematic sleep in autistic children compared with controls. During treatment sleep patterns of all children… 
Long‐term follow‐up of melatonin treatment in children with ADHD and chronic sleep onset insomnia
It is concluded that melatonin remains an effective therapy on the long term for the treatment of CSOI in children with ADHD and has no safety concerns regarding serious adverse events or treatment related co‐morbidity.
Safe and Effective Dosing of Over-The-Counter Melatonin use for Sleep Disturbances in Children with Autism: A Literature Review
  • Pilar Z Murphy
  • Psychology, Medicine
    Open Access Journal of Toxicology
  • 2019
Melatonin is seemingly safe and effective in helping autistic children with sleep disturbances by helping them go to sleep faster and stay asleep longer, thus giving them a better night’s rest.
The efficacy of melatonin for sleep problems in children with autism, fragile X syndrome, or autism and fragile X syndrome.
The results of this study support the efficacy and tolerability of melatonin treatment for sleep problems in children with autistic spectrum disorder and fragile X syndrome.
Melatonin for Insomnia in Children With Autism Spectrum Disorders
Melatonin appears to be a safe and well-tolerated treatment for insomnia in children with autism spectrum disorders, and controlled trials to determine efficacy appear warranted.
Melatonin Versus Placebo in Children with Autism Spectrum Conditions and Severe Sleep Problems Not Amenable to Behaviour Management Strategies: A Randomised Controlled Crossover Trial
Melatonin significantly improved sleep latency and total sleep compared to placebo, but not number of night wakenings, and the side effect profile was low and not significantly different between the two arms.
Relation of Melatonin to Sleep Architecture in Children with Autism
Higher urinary 6-SM excretion rates were associated with increased N3 sleep, decreased N2 sleep, and decreased daytime sleepiness, and the results warrant further examination to examine the effects of supplemental melatonin on sleep architecture and daytimeSleepiness.
Adverse Events Associated with Melatonin for the Treatment of Primary or Secondary Sleep Disorders: A Systematic Review
There are insufficient robust data to allow a meaningful appraisal of concerns that melatonin may result in more clinically significant adverse effects in potentially at-risk populations, and the scarcity of evidence from long-term RCTs limits the conclusions regarding the safety of continuous melatonin therapy over extended periods.
Melatonin: From Pharmacokinetics to Clinical Use in Autism Spectrum Disorder
Melatonin represents currently a well-validated and tolerated treatment for sleep disorders in children and adolescents with ASD and a more thorough consideration of factors influencing melatonin pharmacokinetics could illuminate the best use of melatonin in this population.


Clinical trials of controlled‐release melatonin in children with sleep–wake cycle disorders
The studies showed that the FR melatonin was most effective when there was only delayed sleep onset, but CR formulations were more useful for sleep maintenance, and children appeared to require higher doses than adults.
Melatonin improves health status and sleep in children with idiopathic chronic sleep-onset insomnia: a randomized placebo-controlled trial.
Melatonin improves health status and advances the sleep-wake rhythm in children with idiopathic chronic sleep-onset insomnia.
Effectiveness of melatonin in the treatment of sleep disturbances in children with Asperger disorder.
Melatonin may provide an interesting new and well-tolerated treatment option for children with Asperger disorder suffering from chronic insomnia, however, these results must be confirmed in a controlled study.
Effects of a Low Dose of Melatonin on Sleep in Children with Angelman Syndrome
The data suggest that a moderate increase in circulating melatonin levels significantly reduces motor activity during the sleep period in Angelman syndrome children, and promotes sleep.
Melatonin treatment for sleep disorders in children with neurodevelopmental disorders: an observational study.
The study aim was to quantify melatonin-associated improvement in sleep by means of a parent-completed sleep diary during routine outpatient activity and found that 34 patients who were assessed showed an improvement.
Use of melatonin in the treatment of paediatric sleep disorders
Melatonin appears to be a safe, inexpensive, and a very effective treatment of sleep‐wake cycle disorders in children with disabilities, especially since multidisabled children with chronic sleep difficulties do not respond well to current therapeutic regimes.
Melatonin for the treatment of sleep disturbances in major depressive disorder.
Slow-release melatonin was effective in improving the sleep of patients with major depressive disorder and had no effect on the rate of improvement in symptoms ofmajor depressive disorder.
Long‐term melatonin treatment in blind children and young adults with circadian sleep‐wake disturbances
Oral melatonin therapy was used to treat severe circadian sleep‐wake disturbances in eight children and young adults in an open study, promising as an efficient and seemingly safe alternative for treatment of severe circadianSleep disturbances.
Serum melatonin kinetics and long-term melatonin treatment for sleep disorders in Rett syndrome
Effect of melatonin on sleep–wake rhythm: The sleep diary of an autistic male
  • Etsuko Hayashi
  • Medicine, Psychology
    Psychiatry and clinical neurosciences
  • 2000
A 14‐year‐old autistic male with severe mental retardation was given melatonin at a dose of 6 mg at 9:00 pm (C1) or 11:00pm (C2) and in C2, night sleep was prolonged and sleep–wake rhythm was improved.