Why sleep specialists increasingly see patients using melatonin and how to help them.

By Alyx Arnett

Adults’ use of melatonin supplements in the United States has more than quintupled between 1999 and 2018,1 a trend Judith Owens, MD, MPH, director of sleep medicine at Boston Children’s Hospital, has noticed in her clinical sleep practice. Almost every patient, regardless of age, who was coming in with a complaint of insomnia had either been on or was on melatonin, she says. While the increase was gradual, she noticed a significant uptick in the last seven to eight years. 

With its easy accessibility over the counter and reputation as a natural sleep aid, the supplement is an appealing option for those struggling with sleep-related issues. A recent survey from the American Academy of Sleep Medicine (AASM) found that 64% of people have taken melatonin, with nearly one-third reporting using it occasionally or regularly to help them sleep. 

Despite its widespread usage, guidelines from the American College of Physicians (ACP) and AASM recommend against melatonin for managing chronic insomnia in adults.2,3 AASM based its recommendation on a lower degree of certainty in the outcome and appropriateness for all patients, while ACP cited insufficient evidence of melatonin’s effectiveness.

So why is melatonin use so prevalent? In Owens’ experience, it’s due to a number of factors. Leading those is the successful marketing by melatonin manufacturers, who promote the supplement as a natural solution for enhancing sleep. Lourdes DelRosso, MD, PhD, professor of family and community medicine and medical director of the sleep center at the University of California San Francisco Fresno, agrees, saying, “People have the knowledge that melatonin is a naturally producing substance, and being naturally produced, they feel safer than having some medication.” 

The COVID-19 pandemic may have further exacerbated the trend, according to Kelly Johnson-Arbor, MD, medical toxicologist, co-medical director, and interim executive director at National Capital Poison Center. “The physical and psychological stresses associated with the COVID-19 pandemic contributed to additional disruptions in sleep quality,” she says. “The widespread disruptions in sleep schedules and sleep quality that have occurred as a consequence of the COVID-19 pandemic have likely prompted increasing numbers of people to use melatonin, magnesium, and other dietary supplements to enhance their duration and quality of sleep.”

The increase also mirrors a growing recognition of the vital role sleep plays in overall health and well-being. “This behavior would signify that more and more people are thinking about sleep, and that’s a positive,” says Philip Cheng, PhD, a sleep researcher at the Henry Ford Sleep Disorders and Research Center. “I don’t know that I would say that increased usage of melatonin is a positive thing. My guess is a lot of that is well-intentioned but potentially misguided.” 

Another contributing factor, in Owens’ opinion, could be that more pediatricians are recommending melatonin to children. She says she recently has seen an increase in families reporting that the recommendation came from their pediatrician, something she didn’t encounter in the past—a shift she calls “a big problem.”

Melatonin Draws Mixed Opinions 

There’s some evidence that melatonin, a hormone naturally produced by the pineal gland in the brain, may help with sleep-related issues. A meta-analysis of seven studies found the supplement improves sleep quality with respect to sleep onset latency and total sleep time, and a separate meta-analysis of 23 randomized controlled trials indicated melatonin had “significant” positive effects on sleep quality.4,5 

Additionally, it has been recognized by the Mayo Clinic as a safe option for short-term use in promoting sleep.6 But not all sleep specialists are sold. “Maybe it works, but it probably doesn’t, which is why they end up in my office,” says Owens.

Cheng says melatonin isn’t a sleep aid—like how it’s marketed—but can assist with sleep timing. Melatonin is naturally produced in response to darkness and plays a crucial role in regulating sleep-wake cycles and signaling the body when it’s time to sleep. Melatonin is typically released by most people’s bodies between 8 and 10 pm, and the onset of sleepiness usually occurs approximately two hours later, he says.

Taking a melatonin supplement, then, can help shift the sleep-wake cycle for situations like jet lag, shift work, and delayed shift-wake sleep disorder (DSWPD). By signaling the body that it’s time to sleep when melatonin levels are not naturally elevated, these supplements can help facilitate the desired shift in the sleep schedule, he says. A 2015 clinical practice guideline from AASM recommends clinicians treat DSWPD in adults with strategically timed melatonin, though evidence to support it was still labeled as “weak.”7 

AASM also recommends melatonin to help with REM sleep behavior disorder,8 and some studies have pointed to the benefit of melatonin for sleep-related issues in children with developmental disorders, like autism spectrum disorder and ADHD.9, 10 “There’s definitely a place for melatonin, and there is definitely a benefit on some patients,” says DelRosso.

Some sleep specialists are still wary of the supplement for other reasons. For one, the long-term effects of melatonin use have not been extensively studied, and questions remain about potential effects on hormone regulation, fertility, and overall health when used over an extended period. “Melatonin is not a supplement that physicians know a lot about in general,” says Cheng.

Moreover, melatonin is not regulated by the US Food and Drug Administration. This means the quality and dosage consistency can vary significantly between brands and even between batches. In one study, melatonin content varied from −83% to 478% of labeled melatonin, and the content of melatonin between lots of the same product varied by as much as 465%.11

“In most of the world, melatonin is by prescription only. And because it’s not in the US, it’s not really well-regulated,” says Owens. She notes that certain prescriptions include extended-release formulas, which can potentially provide enhanced efficacy in maintaining sleep, though those aren’t available in the US. Owens suggests that introducing a prescription-based melatonin formulation in the US would offer significant advantages. It would provide clinicians with a reliable and validated option, along with clear guidelines for dosing, timing, and indications—all of which are currently lacking. 

“I don’t realistically envision that all melatonin is all of a sudden going to become prescription only,” she says. “But over time, if there is a prescription alternative, then I think the public will, I hope, appreciate that and turn to those products or that product that does have the science behind it.”

Best Practices for Melatonin Usage

As more patients are relying on melatonin, Cheng encourages physicians to stay informed about its effects, optimal usage, and potential risks. “I would recommend that sleep and other physicians do a little bit of education or seek out education around what melatonin is, what the recommended doses are,” he says. 

Melatonin is being sold at doses that are much higher than the physiological doses, according to Cheng. He typically sees patients using five to 10 milligrams when the recommended doses are 0.5 to three milligrams. “Oftentimes, the physicians or the clinical providers who know more about melatonin end up having a list of pharmacies that sell the one-milligram melatonin and then recommending that people use a pill cutter to cut the one milligrams into 0.5 to start off with,” he says.  

According to Cheng, certain individuals may exhibit sensitivity to higher doses of melatonin, resulting in grogginess in the morning, even after eight to 12 hours of sleep, due to the lingering effects of the supplement in their system. Additionally, some people have reported experiencing vivid and intense dreams as a potential side effect of higher doses. Johnson-Arbor notes that excessive doses can also lead to other unexpected adverse events, including excessive drowsiness, diarrhea, agitation, and headaches.

When choosing a melatonin supplement, Johnson-Arbor recommends looking for one that has undergone independent, third-party testing and is marked as such with labeling from USP, ConsumerLab, or NSF. Supplements that undergo third-party testing are assessed for the presence of impurities, supplement potency, and alignment with good manufacturing practices, she says. 

Owens emphasizes the importance of using pharmaceutical-grade melatonin and suggests that individuals who are unsure about what qualifies as pharmaceutical-grade consult their pharmacist. She recommends the brand Natrol, which she says has been used in clinical trials with children primarily with autism, to her patients.12 Owens notes she has no affiliation with the company and does not receive any form of compensation.

Additionally, sleep specialists should talk with their patients who are using or considering using melatonin about all medications and supplements they’re taking, as Johnson-Arbor adds that melatonin may interact with other medications and dietary supplements, putting them at risk of experiencing unwanted drug-drug interactions. 

Several sleep experts agree that melatonin should be taken for the shortest possible time, in the lowest dose possible, and that it shouldn’t be viewed as a long-term solution for sleep issues. 

Melatonin Use in Otherwise Healthy Children

Many sleep specialists do not recommend melatonin as a sleep aid for otherwise healthy children. Owens stresses that its long-term effects in children are still unknown and that “the vast majority of sleep problems are behavioral in nature, and therefore…it’s behavioral interventions that fix the problem, not melatonin.” 

AASM recommends parents talk to a health care professional before giving melatonin to children and suggests that behavior changes, along with changes in schedules or habits, may offer more effective management of sleep problems in children.13 

Except in “extremely rare circumstances,” Owens says melatonin should never be given to a child under age 2.

“My best advice for parents is: Have your child evaluated for their sleep problems. If you believe that you need to start giving melatonin to the child on a long-term basis, have them evaluated by a sleep doctor,” says DelRosso.

As melatonin usage has surged in recent years, so have overdoses in children. From 2012 to 2021, pediatric melatonin exposures reported to Poison Control Centers across the US increased by over 500%, according to Johnson-Arbor. While most of these exposures were not associated with significant toxicity, some children did experience severe respiratory symptoms, and two deaths were reported. Most of these ingestions occurred in children younger than 5 years old, and nearly all occurred in a residential setting. 

Johnson-Arbor believes many of these exposures were likely unintentional, “reflecting a need for parents and caregivers to ensure that all medications and dietary supplements are kept up high and out of reach of young children,” she says. 

Getting to the Root of the Sleep Issue   

Sleep specialists emphasize the importance of investigating and addressing the underlying causes of sleep issues in patients using melatonin. “As sleep physicians, we need to identify what are the causes of the sleep disturbance,” says DelRosso. “I first assess the patient and see if there are any underlying diagnoses, undiagnosed sleep disorders, and what are the reasons. There is a wide spectrum of reasons why people have sleep disorders, and at the same time, there is a wide spectrum of treatments.”

Recommendations may include cognitive behavioral therapy for insomnia—which is recommended by AASM as first-line treatment for chronic insomnia—improved sleep hygiene practices, and, in some cases, prescription medications specifically designed to treat insomnia.14 

DelRosso says patients should undergo the right diagnostic steps, and, if melatonin is used, there must be frequent reevaluation, reassessment, and maybe considering tapering for patients with insomnia. “Partner with other practitioners to help the patient in all the areas that are needed, and maybe melatonin could be a temporary help while you’re working out other things,” she says. 

Cheng advises physicians to inquire about the reasons behind their patients’ use of melatonin, the manner in which it is being used, and to offer education regarding alternative options. 

Owens agrees that such communication is key. “I would certainly encourage sleep physicians to have an honest discussion with families about this and try to get a sense of where they’re coming from, what their experiences with prior medications have been, and what they’re hearing about melatonin use. It requires some real discussion,” she says. 

DelRosso sees the surge in melatonin use as an opportunity to educate patients on treatment options and identify potentially undiagnosed sleep disorders. “I definitely see this interest in melatonin as an ally that will help us bring awareness to the community that sleep is important, and you have options. But once those options are needed in a longer way, let’s just talk about what other problems could there be,” DelRosso says. 

References

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  11. Grigg-Damberger MM, Ianakieva D. Poor quality control of over-the-counter melatonin: what they say is often not what you get. J Clin Sleep Med. 2017 Feb 15;13(2):163-5. 
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