More Parents Are Giving Kids Melatonin to Sleep. Is It Safe?

An apparently increasing number of parents are giving melatonin to children to help them fall asleep -- based on reports from doctors and researchers -- despite continued concerns in the U.S. and abroad about the potential impact of the supplement on children's health, particularly long term.

Sales of the supplement, a synthetic form of the naturally occurring hormone that helps control sleep-wake cycles, have increased more than 500 percent since 2003, from $62 million to $378 million in 2014, according to the Nutrition Business Journal. While the figures aren't broken out by children or adults, many melatonin supplements are specifically made for kids, featuring fruity flavors and chewable tablets.

"It's obviously anecdotal, but I would say it's almost rare for a family to come in for a sleep clinic evaluation and have not tried melatonin for their children with insomnia," says Dr. Judith Owens, director of sleep medicine at Boston Children's Hospital. "I think the word has gotten out, both to parents and primary care providers, that melatonin is potentially a quick fix for a child who has difficulty falling asleep."

Amazon.com reviews of melatonin products for children tell a tale of parents emerging victorious in the thorny fight to ensure toddlers and young kids get shut-eye. Some call melatonin a "godsend," while others rave about "peace and quiet" at long last; an end to a waking nightmare. Interwoven in the narrative, however, are unsettling implications that some parents are using the supplement as a substitute for recommended bedtime routines, along with concerns from parents themselves. Worried about the strength of children's melatonin, one parent took the children's version of the supplement after giving it to two kids: "It knocked me on my ass!!" reads the review. "I had a great night sleep, but feel it is way too powerful for young children!!!" The parent opted to continue giving it at a lower dose. Another parent worried about the potentially serious implications of a stinky issue: "There is a side effect with these pills: It activates sweat glands in the body. After two weeks of usage my son armpits smelled awful. I was concern[ed] that he was reaching puberty too soon."

To date, research hasn't determined whether melatonin use could affect the onset of puberty or whether there are any other long-term effects on children's health, Owens says. "Melatonin actually suppresses some hormones that regulate puberty. So, the concern is that chronic use of melatonin could alter normal pubertal development," she says, adding that, at present, there's no evidence to support this -- at least that's been published. "It's more of a theoretical concern at this point, but I think that's [what] tends to be most worrisome."

Owens and other doctors point out that melatonin may be a fitting option for parents of children with autism and other chronic health conditions that make it difficult to relax and fall asleep. It's important, however, to couple it with behavioral interventions, such as keeping consistent bedtimes and setting limits that don't allow children to stall by keeping parents at their bedside, as well as creating an environment that makes it easier to unwind, including not allowing TVs and other electronics in the bedroom, experts say, and to aim to ultimately wean kids off the supplements, when and where possible.

"Melatonin will help about 20 to 30 percent of the population fall asleep more easily when given prior to bedtime," says Dr. Craig Canapari, director of the Pediatric Sleep Center at Yale-New Haven Children's Hospital in Connecticut. He adds that an important consideration for parents is whether they have tried everything else first, before giving the supplement. "The most effective interventions for insomnia are often behavioral," he says. "Improving sleep hygiene, avoiding screen time in the evenings [and] limiting sleep in the afternoon and sleeping in on the weekends may be more effective over time than medication."

Instead, experts say some parents and even physicians are too quick to push otherwise healthy kids to pop pills, rather than getting to the root of sleep problems, which could be medical or behavioral.

Earlier this year, sleep researchers at the University of Adelaide in Australia warned doctors and parents not to provide melatonin to kids for sleep problems. In a paper published in the Journal of Paediatrics and Child Health in February, authored by professor David Kennaway, who has studied melatonin for 40 years, Kennaway cautioned that use of the supplement in kids may result in serious side effects when the children are older.

"The use of melatonin as a drug for the treatment of sleep disorders for children is increasing and this is rather alarming," Kennaway said in a statement. He noted in the paper that there's extensive evidence from animal and human studies that the supplement causes changes in physiological systems, including the reproductive, cardiovascular, immune and metabolic systems. "The word 'safe' is used very freely and loosely with this drug, but there have been no rigorous, long-term safety studies of the use of melatonin to treat sleep disorders in children and adolescents."

Though not regulated by the U.S. Food and Drug Administration as a prescription drug would be, melatonin makers describe the product as safe, and clinicians say it's not habit-forming and doesn't carry the risk of overdose or other serious complications.

Dr. Stan Spinner, chief medical officer of Texas Children's Pediatrics, which has practices throughout the Houston area, says side effects may include dizziness, headaches and daytime sleepiness, with higher doses of melatonin. "None of those are good things," he says. "But there's really been nothing serious reported with it."

Even so, he echoes that a lack of research on the supplement's long-term effects coupled with the lack of federal oversight gives parents reason to be cautious. Like other clinicians, he says it's important to consult a child's doctor before giving a child any medication, including over-the-counter supplements -- which he says parents often don't think to discuss with physicians. Experts say that medications, supplements and even vitamins can interact with each other -- sometimes to nullify effectiveness or increase the risk of side effects.

"For a healthy child, who may just not be a good sleeper, I tell [parents] that I would not necessarily give it to my child," Spinner says. However, he says that for parents who have all the facts, the choice is ultimately up to them, though it should be made in concert with their physician.

Owens stresses that it's important for parents to first seek to understand and address the root of sleep problems -- whether it be restless-leg syndrome or just bad sleep habits -- rather than reaching for a quick fix.

She encourages parents to discuss their concerns with their child's primary care provider, rather than automatically going to the pharmacy to purchase over-the-counter melatonin. The latter approach, she says, risks sending the wrong message to parents and children: "That when you can't sleep you, pop a pill. And I think that's a very dangerous message to send."

Michael Schroeder is a health editor at U.S. News. You can follow him on Twitter or email him at mschroeder@usnews.com.