Increased education, clearer guidelines needed on melatonin use in children

Key takeaways:

• Providers should familiarize themselves with the literature on melatonin and its use in children.
• Clinical practice guidelines need to be more definitive regarding recommendations for melatonin use in children.

INDIANAPOLIS — In a session on melatonin use in children, Judith Owens, MD, MPH, aimed to pique discussion among attendees about the challenges of talking with parents and families about the supplement’s use in this patient population.

“I think it’s become fairly obvious that melatonin really now is the ‘go-to’ pharmacologic intervention for insomnia in children, and that is a worldwide phenomenon,” Owens, director of the Center for Pediatric Sleep Disorders at Boston Children’s Hospital and professor of neurology at Harvard Medical School, said.

She cited data from a study in Norway that demonstrated melatonin use in children doubled from 2004 to 2011 (Hartz I, et al), as well as a Swedish study that showed a 15-fold increase in use among girls and a 20-fold increase in use among boys between 2006 and 2017 (Kimland EE, et al). In this same study, a substantial percentage of children were prescribed melatonin over a prolonged period of time — often with concomitant use of psychotropics — and many of them also had mental health comorbidities, Owens said.

In a U.S. study published in MMWR in 2020, 1.3% of children used melatonin for “sleep, stress and relaxation.”

“I would argue that, in addition to the adverse events that have been presented ... recommending melatonin for children who do not need it is a major concern, and we really need to start paying attention to that,” she said.

In 2020, data from an online survey for The New York Times found that about one-third of parents reported their children had sleep issues in the last year, and almost half of those parents had given their children melatonin for this issue.

“The second adverse event, in my book, is teaching children that if they can’t sleep, they take a pill — or a gummy, or a liquid — but there’s something that is making them fall asleep. And what kind of message is that to give, particularly to young children? Let’s think about that.

“We know there’s a high level of awareness and acceptance among caregivers and providers, particularly primary care pediatricians,” Owens said, citing a 150% increase in U.S. sales of melatonin between 2016 and 2020.

According to Owens, although classified as a dietary supplement, melatonin has become an ingredient in over-the-counter nighttime cough medicines for children, and is being marketed to promote “healthy, peaceful sleep.”

“In other words, children don’t have to have insomnia symptoms to be given melatonin; it’s just going to ‘help them sleep better,’” she said. “And I think that’s truly an insidious part of this that we, as health professionals, need to take on and address.”

To complicate things further, the dearth of long-term data on the safety of its use, the select populations included in randomized controlled trials and the lack of clinical practice guidelines present challenges during patient visits, especially given the amount of conflicting information caregivers have access to — whether from news sources or Twitter, where more than 37% of melatonin-related tweets came from “random users” vs. 1.4% by health care professionals and academic institutions, according to a study cited by Owens.

“There’s such a variety in information that caregivers, parents have access to that I think is very important because we, as health care providers, need to understand the data and transmit that in way that families can understand and find relevant.”

One suggestion from Owens: Providers should familiarize themselves with the “seminal” study by Erland and Saxena published in the Journal of Clinical Sleep Medicine in 2017, which described the variability in content — including the presence of serotonin — among 31 melatonin supplement products they studied. Based on the results, Owens advises the families she sees to take pharmaceutical-grade melatonin.

“The messaging that is out there; we need to be aware of it. And again, hopefully we’re the trusted entity that families are coming to,” she said.

Owens and colleagues are in the process of conducting a qualitative study for the development of a sleep health education program and are interviewing providers about sleep health. So far, they’ve found primary care providers and pediatricians want more information on melatonin. Yet, the available clinical guidelines regarding its use recommend patients speak with their health care providers.

“Is this the blind leading the blind?” Owens asked. “... I don’t mean to get down on pediatricians — I’m a pediatrician! And in the trenches, you may not have a whole lot of time to discuss this, so we need to get the correct information out there.”

References:

• Erland LAE, et al. J Clin Sleep Med. 2017;doi:10.5664/jcsm.6462.
• Hartz I, et al. Scand J Public Health. 2012;doi:10.1177/1403494812464446.
• Kimland EE, et al. Eur Child Adolesc Psychiatry. 2021;doi:10.1007/s00787-020-01598-1.
• Parents are relying on melatonin to help their kids sleep. Should they? https://www.nytimes.com/2020/05/18/parenting/melatonin-sleep-kids.html. Published May 18, 2020. Updated Jan. 18, 2022.
• Stierman B, et al. MMWR Morb Mortal Wkly Rep. 2020;doi:10.15585/mmwr.mm6943a1.