Is melatonin suitable for a 19-month-old child?

From the Guidelines

I strongly advise against giving melatonin to a 19-month-old child without consulting a pediatrician first. The American Academy of Sleep Medicine clinical practice guideline from 2015 1 provides moderate evidence for the use of melatonin in pediatric patients, but it does not specifically address children as young as 19 months. The recommended dose of 0.15 mg/kg, taken 1.5–2.0 hours prior to habitual bedtime, for 6 nights, is based on a study with a moderate level of evidence, but the benefits and harms assessment is uncertain, particularly in the pediatric population. Some key points to consider when deciding whether to use melatonin in a child this young include:

• The lack of rigorous long-term data on the safety and efficacy of melatonin in children under 2 years old
• The potential risks of affecting the developing endocrine system or having unknown long-term effects
• The importance of establishing consistent bedtime routines, maintaining a regular sleep schedule, creating a calm sleep environment, and limiting screen time before bed
• The need for a pediatrician to evaluate for underlying medical conditions that may be affecting sleep, such as sleep apnea or reflux. Given these considerations, it is crucial to consult with a pediatrician before giving melatonin to a 19-month-old child, as they can provide personalized guidance and help determine the best course of treatment for the child's specific sleep issues 1.

From the Research

Melatonin Use in Pediatrics

• Melatonin can be safe and effective in treating primary sleep disorders and sleep disorders associated with various neurological conditions in children 2.
• However, there is still uncertainty concerning dosing regimens and a lack of other data, and the dose of melatonin should be individualized based on multiple factors, including the severity and type of sleep problem and the associated neurological pathology 2.
• The majority of studies evaluating melatonin use in the pediatric population are conducted with children who have comorbidities, such as autism spectrum disorder or attention-deficit/hyperactivity disorder, and evidence supporting the use of melatonin in the otherwise healthy pediatric population is limited 3.

Efficacy of Melatonin for Sleep Initiation and Maintenance Problems

• A systematic review and network meta-analysis found that melatonin and light therapy were more effective than evidence-based psychological interventions for reducing sleep onset latency in healthy pediatric populations 4.
• However, evidence-based psychological interventions and a combination of those techniques plus light treatment were the most efficacious for reducing wake after sleep onset 4.
• A combination of evidence-based psychological intervention with light therapy showed a larger effect for increasing total sleep time compared to other interventions 4.

Combination of Melatonin and Cognitive-Behavioral Therapy

• A randomized placebo-controlled trial found that the combination of controlled-release melatonin and cognitive-behavioral therapy resulted in improvements across all outcome measures, including sleep latency, total sleep time, wake after sleep onset, and number of awakenings, in children with autism spectrum disorders 5.
• The combination treatment group showed a trend to outperform other active treatment groups, with fewer dropouts and a greater proportion of treatment responders achieving clinically significant changes 5.

Safety and Regulation of Melatonin

• Melatonin is regulated differently around the world, with the least amount of regulation placed on over-the-counter supplements in the United States 3.
• There is a lack of safety regulations in place in the United States, and the use of melatonin in the otherwise healthy pediatric population should be approached with caution 3.
• Melatonin overdose is a potential risk, and studies have shown a dramatic increase in use and resulting side effects, including melatonin overdose, particularly after the COVID-19 pandemic 6.