Q: Is melatonin safe for children? I have heard that it is, but I have also read some articles recently that say that might not be the case. I am not sure about which are the reputable sites and publications to get my information from so I thought the best idea would be to take the question to you.
A: Before we consider melatonin’s safety and efficacy, let’s look at what melatonin is.
Melatonin is a hormone which is naturally produced by the pineal gland inside our brains. Its main function is to regulate the inner body-clocks (the circadian sleep-wake cycle) present in all mammals. Melatonin is an evolutionary staple and helps us stay awake during daylight and sleep when the sun disappears. Here’s a nice explanation from the National Sleep Foundation of how melatonin works:
During the day the pineal is inactive. When the sun goes down and darkness occurs, the pineal is “turned on” […] and begins to actively produce melatonin, which is released into the blood. Usually, this occurs around 9 pm. As a result, melatonin levels in the blood rise sharply and you begin to feel less alert. Sleep becomes more inviting. Melatonin levels in the blood stay elevated for about 12 hours – all through the night – before the light of a new day when they fall back to low daytime levels by about 9 am. Daytime levels of melatonin are barely detectable.
In teenagers, the natural release of melatonin is often delayed by an hour or two. Again, there may be an evolutionary reason for this. Pediatric sleep expert Craig Canapari, M.D. says exposure to the blue-white light of electronic devices can delay the natural release of melatonin in everyone:
This is why bright light exposure in the evenings can worsen insomnia. I highly recommend eliminating ANY screen time for preschool through elementary school children for an hour prior to bedtime. That means no light emitting Kindles, iPads, smartphones, computers, or (God forbid) television in the bedroom For students in junior high and beyond who need to use computers to complete school work, I highly recommend lowering brightness settings and using software to reduce the blue light frequencies.
The use of melatonin as a sleep aid has been rising substantially in recent years. In the European Union, Australia, and other places, melatonin is available only by prescription. In the United States, melatonin is considered a dietary supplement and is not regulated by the Food and Drug Administration (FDA). Parents often like the idea of using “natural” products to help their children. However, the melatonin we buy and use as medicine is not “natural”; it is synthesized in laboratories using plant-based products and chemicals. (“All natural” melatonin, derived from the brains of cows and pigs, fell out of favor years ago with the threat of mad cow disease. Remember this rule of thumb: Just because something is “natural” does not mean it is safe.)
Because melatonin is not a regulated substance, there is limited clinical information in children addressing its efficacy and safety in helping children fall asleep faster and stay asleep longer. Bruni et al summarize the international consensus (2014) that melatonin is safe and effective for treating some primary and secondary sleep disorders in children:
The best evidence for efficacy is in sleep onset insomnia and delayed sleep phase syndrome. It is most effective when administered 3–5 h before physiological dim light melatonin onset. There is no evidence that extended-release melatonin confers advantage over immediate release. Many children with developmental disorders, such as autism spectrum disorder, attention-deficit/hyperactivity disorder and intellectual disability have sleep disturbance and can benefit from melatonin treatment. Melatonin decreases sleep onset latency and increases total sleep time but does not decrease night awakenings…
Animal work and limited human data suggest that melatonin does not exacerbate seizures and might decrease them. Melatonin has been used successfully in treating headache. Animal work has confirmed a neuroprotective effect of melatonin, suggesting a role in minimising neuronal damage from birth asphyxia; results from human studies are awaited. Melatonin can also be of value in the performance of sleep EEGs and as sedation for brainstem auditory evoked potential assessments. No serious adverse effects of melatonin in humans have been identified.
Pediatrician Stuart Ditchek, an advocate for complementary and alternative medications (CAM) and treatments in children, has some serious concerns about the use of melatonin in children, warning pediatricians not to put their “unofficial stamp of approval to the daily use of melatonin” for their patients:
The other issue that parents should consider is the impact of lessons being taught from the youngest age as to a child’s perception and training. Those who are giving their children nightly or frequent melatonin are sending a very direct message to children that a pill or a drug is needed to succeed or accomplish a task that should come naturally. This is a bad habit to imprint in a child’s impressionable mind and one that could have negative impacts in the future as the child enters adolescence. Teaching a child that a pill can easily replace a discipline is just plain bad parenting. It should not come as a surprise if the children being acclimated to daily melatonin today will become the narcotic sleep aid dependent adult of the future.
Until more studies are done, especially ones that rule out melatonin’s purported interference with other hormones which regulate sexual development and puberty, Dr. Ditchek wants pediatricians and parents to proceed with great caution:
The occasional use is likely fine but never for more than seven to ten days at a time and never with a greater frequency than two or three times a year. Even that frequency might not be completely safe but future research will tell.
If that isn’t enough to dissuade you, read the list of potential side effects from N-acetyl-5-methoxytryptamine (melatonin) at the Mayo Clinic’s website.
As far as melatonin’s proper dosing is concerned, the National Sleep Foundation punts:
Because it is not categorized as a drug, synthetic melatonin is made in factories that are not regulated by the FDA. Listed doses may not be controlled or accurate, meaning the amount of melatonin in a pill you take may not be the amount listed on the package. Most commercial products are offered at dosages that cause melatonin levels in the blood to rise to much higher levels than are naturally produced in the body. Taking a typical dose (1 to 3 mg) may elevate your blood melatonin levels to 1 to 20 times normal.
We’d better leave it to the pediatric sleep expert, Dr. Canapari:
- Timing: For shifting sleep schedules earlier 3–6 hours before current sleep onset is best. For the sleep onset effects, 30 minutes before bedtime is recommended. Remember, not every child gets sleepy with melatonin.
- Dosing: In general, I would start at a low dose (0.5–1 mg) and increase slowly. Recognize that melatonin, unlike other medications, is a hormone, and that lower doses are sometimes more effective than higher ones, especially if the benefit of it reduces with time.
- Good Sleep Hygiene is Critical: Melatonin is not a substitute for good sleep hygiene practices and should only be used in concert with a high quality bedtime, limitation on light exposure, and an appropriate sleep schedule.
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