From the Guidelines
Melatonin can be used to treat sleep disorders in children, but its use should be approached with caution and under medical supervision, with optimal results obtained with a dose of 0.15 mg/kg, taken 1.5–2.0 hours prior to habitual bedtime, for 6 nights, as recommended by the American Academy of Sleep Medicine clinical practice guideline 1. When considering the use of melatonin in children, it is essential to weigh the potential benefits against the potential harms, as the long-term effects of melatonin use in this population are not well understood.
- The American Academy of Sleep Medicine clinical practice guideline suggests that melatonin may be effective in treating certain sleep disorders in children, including intrinsic circadian rhythm sleep-wake disorders 1.
- A study published in the Journal of Clinical Sleep Medicine found that melatonin was effective in reducing sleep problems in children with autism spectrum disorders, with typical dosages ranging from 0.5 to 6 mg taken 30-60 minutes before bedtime 1.
- However, it is crucial to note that melatonin should not be used as a substitute for good sleep hygiene practices, and parents should try behavioral interventions first before considering melatonin supplementation.
- Potential side effects of melatonin use in children include morning drowsiness, headaches, and increased bedwetting, and parents should be aware of these risks when deciding whether to use melatonin 1.
- The dosage and treatment duration of melatonin should be regularly reassessed, and parents should start with the lowest effective dose to minimize potential side effects.
- Maintaining consistent bedtime routines, limiting screen time before bed, and ensuring the bedroom environment is conducive to sleep are also essential for promoting healthy sleep habits in children.
From the FDA Drug Label
Helps establish normal sleep patterns 100% Drug-free and non-habit forming melatonin is a nighttime sleep aid for occassional sleeplessness.
The FDA drug label does not answer the question.
From the Research
Melatonin Use in Children
- Melatonin can be used to treat sleep disorders in children, particularly those with delayed sleep phase syndrome, as it has been shown to synchronize circadian rhythms and improve sleep quality 2, 3.
- For children with otherwise undiagnosed insomnia and healthy sleep hygiene, melatonin use should be considered, but its routine use among healthy children is not recommended due to a lack of evidence 2.
- Melatonin has been found to be well-tolerated and safe, with no obvious short- or long-term adverse effects, making it a potential alternative treatment to currently available pharmaceutical therapies for sleep disorders 3.
Indications and Effects
- Exogenous melatonin is typically used for sleep regulation in the context of insomnia in healthy children or those with neurodevelopmental disabilities 4.
- Melatonin is also used for the management of circadian rhythm sleep disorders in pediatric and adolescent patients, and has potential uses in various areas of medicine, including inflammatory conditions 4.
- However, the use of melatonin in infants and toddlers is a concern, as there are no data regarding its safety and efficacy in children less than 2 years old, and its use in this age group is often based on non-supported indications 5.
Regulations and Evidence
- The regulation of melatonin varies around the world, with the least amount of regulation placed on over-the-counter supplements in the United States 6.
- The majority of studies evaluating melatonin use in the pediatric population are conducted with children who have comorbidities, and evidence supporting the use of US formulations of melatonin in the otherwise healthy pediatric population is limited 6.
- As a result, melatonin products should be used sparingly in the otherwise healthy pediatric population, if they are used at all, due to the lack of safety regulations and evidence regarding US melatonin products 6.