What We Know (And Don't Know) About Melatonin's Effects On Kids

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In increasing numbers, parents around the country are turning to over-the-counter melatonin in hopes that the drug will help their kids sleep better. But how effective -- and how safe -- is it? Science doesn't yet point to clear answers. Here's where we stand.

What we do know is that the melatonin parents are purchasing at drug and health-food stores to help their children sleep is a synthetic form of a hormone that our brains naturally produce to help us fall asleep. Melatonin is a “biomarker” of what are known as circadian rhythms, or a complex network of internal “clocks” which regulates not only sleep, but virtually every body function. Melatonin is normally released in the evening (prompted by darkness) and is at low levels by morning and during the day (when light is more plentiful).

There is strong scientific evidence that melatonin can shorten the time to fall asleep when given close to bedtime in doses ranging from 1 to 5 mg to children with ADHD (attention deficit hyperactivity disorder), autism or other neurodevelopmental disorders and who also have insomnia. The evidence points to similar benefits in children without these disorders. There is much less evidence, however, that melatonin, even the “extended release” forms, helps children stay asleep. And it should be emphasized that there are many reasons why children may have trouble falling asleep (including restless legs symptoms, anxiety and a too-early bedtime), so melatonin should not be used until a thorough evaluation for other potential causes has been performed by a child’s pediatrician or other healthcare provider. Moreover, many of these causes of sleep problems are much better addressed with behavioral or other types of interventions. For example, giving melatonin to a child or adolescent who is using light-emitting -- and therefore melatonin-suppressing -- electronic devices just before bed is likely to be a zero-sum gain!

So as a parent, should you worry if your child’s pediatrician does recommend melatonin for sleep? Here are the kinds of confusing messages parents are encountering:

From Medline Plus: “Melatonin should not be used in most children. It is POSSIBLY UNSAFE. Because of its effects on other hormones, melatonin might interfere with development during adolescence.”
From NaturalSleep.org: “Melatonin, according to more than 24 studies, is safe for children and has been used with little to no side effects.”
From Livestrong.com: “Although the use of low doses of melatonin to help children sleep seems to be safe and effective, more research is needed to answer lingering questions.”

This last quote is probably closest to where we actually are. While in general melatonin seems to have few and largely minor side effects in children (such as headaches, increased bedwetting, morning grogginess), there are ongoing (although to date largely theoretical) concerns that the effects of melatonin shown on puberty-related hormones in animal models could also present themselves in humans, especially children. While there is very little evidence to suggest this is indeed the case, no long-term clinical trials (which remain the “gold standard” for answering these kinds of questions) have been conducted yet. Another issue is the consistency of actual melatonin concentration from product to product or even lot to lot; this is why some experts recommend going online and purchasing “pharmaceutical grade melatonin,” which may deliver more consistent doses.

There are times and conditions when melatonin should not be used in children. Those conditions include: If the insomnia is situational (anxiety about a new school year) or self-limited (during an ear infection); if the insomnia is due to an underlying physical cause (like restless legs); or as a substitute for healthy sleep practices (a regular, age-appropriate and consistent bedtime and bedtime routine, no caffeine, no electronics/”screens” before bed). And children under the age of 3 should not take melatonin.

Recent consensus conference guidelines for the use of melatonin in children have recently been published in the European Journal of Paediatric Neurology (2014) and provide a reasonable and balanced approach. The bottom line? The risk-to-benefit ratio for melatonin use in children with significant difficulty falling asleep, in combination with the institution of behavioral interventions and healthy sleep practices, is likely low and could be considered -- in consultation with a healthcare provider.

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