Long-term follow-up of melatonin treatment in children with ADHD and chronic sleep onset insomnia (original) (raw)
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Melatonin and sleep in children with neurodevelopmental disabilities and sleep disorders
Current Paediatrics, 2006
Sleep disorders impair the quality of life for children with neurodevelopmental disabilities and their families. Melatonin, a natural regulator of sleep, may be an effective therapy in this area. Numerous studies in children report that melatonin may be beneficial for sleep. Studies differ widely from each other with respect to the dosage and time of administration. The effectiveness of melatonin depends on a number of factors, including dose, the individual sensitivity of the patient and the time of administration. Few acute adverse effects have been reported. Long-term adverse effects have not been systematically studied. Well-designed, randomised, controlled studies with long-term follow-up in children are needed.
Low Doses of Melatonin to Improve Sleep in Children with ADHD: An Open-Label Trial
Children
Objective. Only a few studies assessing the sleep effects of low doses of melatonin (aMT) have been performed in the past, most of them in adults, and only one in subjects with attention-deficit/hyperactivity disorder (ADHD). The aim of this study was to provide evidence of the changes induced by aMT doses as low as 1 mg in the sleep pattern of pediatric patients with ADHD under treatment with methylphenidate (MPH). Methods. Children and adolescents (7–15 years) with ADHD who were receiving extended-release MPH were recruited. A seven-week sleep diary was collected prior to starting a four-week treatment with 1 mg of aMT (30 min before bedtime). Seven-day actigraphic assessments of sleep were performed before and after treatment. Results. Twenty-seven patients (17 males, 62.96%) participated in the study, who had been receiving MPH for 1.57 (1.11) months. A significant increase in sleep duration (TST) was observed after one month of treatment (463 (49) min to 485 (41) min; p < 0....
Use of melatonin in the treatment of paediatric sleep disorders
Journal of Pineal Research, 1996
A group of Vancouver health professionals, including the authors, have studied the use of oral melatonin in the treatment of chronic sleep disorders in children with disabilities since the Fall of 1991. This review article is based on the first 100 patients, half of whom were visually impaired or blind. Children with neurological, neuropsychiatric, and developmental disabilities are predisposed to chronic sleep-wake cycle disturbances. Disorders such as blindness, deafblindness, mental retardation, autism, and central nervous system diseases, among others, diminish the ability of these individuals to perceive and interpret the multitude of cues for synchronizing their sleep with the environment. Melatonin, which benefitted slightly over 80% of our patients, appears to be a safe, inexpensive, and a very effective treatment of sleep-wake cycle disorders. The oral dose of fast release melatonin taken at bed-time ranged from 2.5 mg to 10 mg. Side effects or the development of tolerance have not been observed. Since the causes of sleep difficulties are extremely variable, not all children are candidates for treatment. For successful melatonin treatment, clinical experience is required, and the influences of other health problems and medications need to be considered. Further clinical and laboratory research in this field is imperative because melatonin treatment offers enormous health, emotional, social, and economic benefits to society, especially since multidisabled children with chronic sleep difficulties do not respond well to current therapeutic regimes.
Effect of Melatonin on Sleep, Behavior, and Cognition in ADHD and Chronic Sleep-Onset Insomnia
Journal of the American Academy of Child & Adolescent Psychiatry, 2007
Objective: To investigate the effect of melatonin treatment on sleep, behavior, cognition, and quality of life in children with attention-deficit/hyperactivity disorder (ADHD) and chronic sleep onset insomnia. Method: A total of 105 medication-free children, ages 6 to 12 years, with rigorously diagnosed ADHD and chronic sleep onset insomnia participated in a randomized, double-blind, placebo-controlled trial using 3 or 6 mg melatonin (depending on body weight), or placebo for 4 weeks. Primary outcome parameters were actigraphy-derived sleep onset, total time asleep, and salivary dim light melatonin onset. Results: Sleep onset advanced by 26.9 T 47.8 minutes with melatonin and delayed by 10.5 T 37.4 minutes with placebo (p < .0001). There was an advance in dim light melatonin onset of 44.4 T 67.9 minutes in melatonin and a delay of 12.8 T 60.0 minutes in placebo (p < .0001). Total time asleep increased with melatonin (19.8 T 61.9 minutes) as compared to placebo (j13.6 T 50.6 minutes; p = .01). There was no significant effect on behavior, cognition, and quality of life, and significant adverse events did not occur. Conclusion: Melatonin advanced circadian rhythms of sleep-wake and endogenous melatonin and enhanced total time asleep in children with ADHD and chronic sleep onset insomnia; however, no effect was found on problem behavior, cognitive performance, or quality of life. J. Am. Acad. Child Adolesc.
Trials, 2016
Background: Attention-deficit/hyperactivity disorder (ADHD) is a common neurological disorder affecting 5 % of children worldwide. A prevalent problem for children with ADHD is initial insomnia. The gold standard treatment to manage ADHD symptoms is stimulant medications, which may exacerbate the severity of existing initial insomnia. Currently, no gold standard treatment option exists for initial insomnia for these children. Melatonin, a hormone and a popular natural health product, is commonly provided to children by parents and recommended by healthcare providers, but high quality pediatric evidence is lacking. Methods/design: This trial is a multicenter randomized triple-blind, placebo-controlled, parallel-group, randomized, controlled trial (RCT), in which each participant is offered an N-of-1 trial. An N-of-1 trial is a multiple-crossover, randomized, controlled trial conducted in a single individual. For the N-of-1 trial, each participant will undergo three pairs of treatment/placebo periods; each period is 1 week in length. Half the participants will have melatonin in the first period, the other half will start with placebo, and this will make up the parallel-group RCT. The primary outcome will be mean difference in sleep onset latency as measured by sleep diaries. A comparison of treatment effects yielded by the RCT data versus the aggregated N-of-1 trial data will also be assessed. Discussion: This trial will provide rigorous evidence for the effectiveness of melatonin in children with ADHD on stimulants who experience initial insomnia. Further, this study will provide the first prospectively planned head-to-head comparison of RCT data with pooled data from a series of N-of-1 trials. Aggregated N-of-1 trials may be a powerful tool to produce high quality clinical trial evidence.
Review of Melatonin Supplementation for Sleep Disorders in Pediatric Special Populations
Journal of Pharmacy Practice, 2019
Objective To determine which pediatric populations, if any, benefit from exogenous melatonin supplementation. Methods PubMed was utilized for the purposes of this systematic review. The studies selected evaluated melatonin use in pediatric special populations and included randomized controlled trials, crossover studies, and meta-analyses. Each study’s objectives, measures of outcomes, and dosing strategies of melatonin were reviewed along with the results and author’s conclusions. Results Our analysis of the available data offers mixed results and recommendations with regard to the decision of whether to add supplementation of melatonin. Conclusion With further regulation of melatonin supplements, it may be plausible to hold larger, multicenter trials and come to a firm recommendation in the future. At this time, we believe that the benefit of exogenous melatonin supplementation outweighs the risks of adverse events and therefore would recommend its use in aiding patients in improvi...