Is Melatonin Safe for Children? Understanding the Risks and Benefits

Quality sleep is crucial for children's well-being, impacting their overall health and functioning. Guidelines from the American Academy of Neurology state that up to 40% of typically developing children experience sleep issues, with higher rates among those with neurodevelopmental disabilities and autism spectrum disorder. Melatonin usage has surged in recent years, prompting concerns over accidental ingestion in children. The American Academy of Sleep Medicine advises parents to consult healthcare professionals before considering melatonin for their children.

What is melatonin?

Melatonin is a naturally occurring hormone in the body. It is secreted by the pineal gland, which is located in the brain. Darkness promotes the secretion of melatonin, which helps promote sleep, while light suppresses melatonin. Melatonin helps regulate the circadian rhythm by acting on melatonin receptors.

Uses for melatonin in children

Melatonin effectively reduces the time it takes to fall asleep (sleep latency) and can extend total sleep time, offering relief for various sleep disorders in children, including:

  • Sleep onset insomnia
  • Sleep disorders associated with autism and neurodevelopmental conditions
  • Circadian rhythm disorders
  • Restless leg syndrome
  • Obstructive sleep apnea
  • Parasomnias (sleepwalking, nightmares, bedwetting)

Is melatonin safe for kids?

According to research, melatonin is most likely safe for specific individuals on a short-term basis. More research is needed on long-term safety and efficacy. Melatonin should only be considered after behavioral modifications and sleep habits have been evaluated. Parents and caregivers should consult with their pediatrician before considering melatonin.

Since melatonin is a supplement in the U.S., the Food and Drug Administration (FDA) has not evaluated or approved it. This means that effective dosing is not well-established and all uses of the medication are considered off-label.

Risks associated with melatonin use in children

Side effects from melatonin are mostly mild and stop when melatonin is discontinued.

Common side effects of melatonin include:

  • Headache
  • Drowsiness
  • Agitation
  • Increased bedwetting or evening urination
  • Dizziness
  • Diarrhea

There is a limited amount of data on long-term melatonin use. One study found a possible link between long-term melatonin use and a delay in puberty. In this study, the average length of melatonin use was 7.1 years. The study showed that using melatonin for up to 4 years had little to no difference in puberty. The data from this study was very limited and not conclusive. More research is needed on the long-term effects and safety of melatonin use.

Many children’s formulations of melatonin come as a flavored gummy. Children could mistake melatonin for candy and ingest too much. It is important that melatonin be stored out of reach of children, and it should be stored in the original child-resistant packaging.

The Centers for Disease Control and Prevention (CDC) has reported that there has been a 530% increase in phone calls to the poison control center for pediatric ingestions of melatonin in the last 10 years. There has also been a 420% increase in emergency department visits due to unsupervised melatonin ingestion in children. Although in most cases the children were asymptomatic (showed no symptoms), some cases involved gastrointestinal, cardiovascular, and central nervous system side effects.

If your child has ingested any medication they should not have, contact poison control (1-800-222-1222) or visit your nearest emergency room.

Safety measures and precautions

Melatonin is a dietary supplement. Supplements are regulated differently than prescription medications. Dietary supplements are regulated as foods and are not required to be tested for safety and effectiveness before selling them.

A study from The Journal of Clinical Sleep Medicine reported that 71% of melatonin supplements did not contain the amount stated on the labeling. While some contained less than half of what they should have, others contained more than 4 times the stated amount. The study also showed that 26% of melatonin supplements contained serotonin. Serotonin is a neurotransmitter and can cause an overdose at low levels. This can lead to dangerous effects, especially in children.

When choosing a dietary supplement, it is advised to choose a product that has been USP-verified. This means that a third party has tested the product and it has met strict criteria.

These criteria include:

  • The product contains the ingredients listed on the label with the correct strengths and amounts.
  • The product does not contain harmful contaminants such as lead, mercury, or pesticides.
  • The product has had verification tests to check performance standards so that the supplement will break down and be absorbed properly.
  • The product was made according to FDA good manufacturing practices by using sanitary and controlled procedures.

Caution in health conditions

Melatonin is not recommended if you have the following conditions:

  • Autoimmune disorders
  • Bleeding disorders
  • Epilepsy or other seizure disorders

Melatonin can interact with some medications. It is important to discuss your child’s medication history with their healthcare provider.

Considerations for melatonin usage in children with sleep disorders

Melatonin to treat sleep disorders may be recommended only after trying other strategies first. This includes proper sleep habits and behavioral therapy. If your provider recommends melatonin, it should be used at the lowest effective dose and for the shortest duration possible.

Melatonin may be considered as a treatment for sleep disorders in children, but it's typically recommended after trying other strategies first, such as establishing proper sleep habits and behavioral therapy. If your healthcare provider suggests melatonin, they'll likely advise starting with the lowest effective dose and using it for the shortest duration possible.

Research suggests that melatonin can be beneficial in certain situations, particularly for children with specific sleep issues. For instance, it's been found useful for children with circadian phase delay, a condition where the internal sleep clock is delayed, causing children to fall asleep and wake up later than desired. In such cases, administering melatonin 1.5–6.5 hours before bedtime can help establish a more regular sleep pattern.

Moreover, children with neurodevelopmental disorders (NDD) and autism spectrum disorder (ASD) are at a higher risk of experiencing sleep difficulties, including trouble falling asleep, staying asleep, frequent night awakenings, irregular sleep patterns, and early morning awakenings. When behavioral strategies prove insufficient in addressing these issues, healthcare providers may consider recommending melatonin. However, it's essential to consult with a pediatrician before giving melatonin to your child.

The American Academy of Pediatrics (AAP) recommends seeking professional guidance to ensure the appropriate use of melatonin and whether it's suitable for your child's specific circumstances.

Alternatives to melatonin for children

Establishing healthy habits can help your child relax and sleep better.

These habits include:

  • Having a regular bedtime routine (bath, brush teeth, story)
  • Keeping the same bedtime and waketime every day
  • Having a comfortable environment: quiet, dark, and cool
  • Avoiding large meals and caffeine close to bedtime
  • Getting plenty of exercise during the day
  • Keeping electronic devices out of the bedroom
  • Avoiding television and electronic devices within an hour of bedtime

If your child has healthy bedtime habits and is still struggling with falling asleep or staying asleep, then it may be time to talk to your pediatrician. They can check for any underlying health conditions and recommend a therapist if needed. Therapists can use cognitive behavioral therapy (CBT) and can help teach relaxation techniques. CBT can help address the thoughts and behaviors that prevent them from sleeping well.

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