Annual pediatric melatonin ingestion up 530% between 2012 and 2021, says CDC report

The report assessed isolated melatonin ingestions among children, adolescents, and young adults 19 years and under between January 1, 2012, and December 31, 2021 using the American Association of Poison Control Centers’ National Poison Data System (NPDS).

A recent report published by the Centers for Disease Control and Prevention shows that pediatric melatonin ingestions have risen significantly as the product has become increasingly popular as a sleep aid. The report assessed isolated melatonin ingestions among children, adolescents, and young adults 19 years and under between January 1, 2012, and December 31, 2021 using the American Association of Poison Control Centers’ National Poison Data System (NPDS).

According to figures from NPDS, the annual number of pediatric melatonin ingestions reported to the Poison Control in that ten-year period increased 530%, from 8,337 in 2012 to 52,563 in 2021, with the largest yearly increase (37.9%) occurring from 2019 to 2020. A total of 260,435 pediatric melatonin ingestions were reported during this time. Additionally, pediatric melatonin ingestions accounted for 4.9% of all pediatric ingestions reported to Poison Control in 2021, compared to 0.6% in 2012.

While most children (82.8%) were asymptomatic, the most common symptoms reported involved the gastrointestinal, cardiovascular, and central nervous systems. Most ingestions were unintentional (94.3%), involving males aged five and under, 99% occurred in the home, and 88.3% were managed on-site. Of the 27,795 patients that received care at health care facilities, 19,892 (71.6%) were discharged, 4,097 (14.7%) were hospitalized, and 287 (1.0%) required intensive care. Unfortunately, 4,555 (1.6%) of all pediatric melatonin ingestions resulted in more serious outcomes, with five children requiring mechanical ventilation, and two deaths. The deaths occurred in children less than two years of age (3 months and 13 months) and occurred in the home. One ingestion involved intentional medication misuse while the reason for the other remains unknown.

Serious adverse events among children remain small, but the growing popularity of melatonin and its incorporation into dietary supplements is raising concerns about the products’ potential misuse and even abuse. Some products are marketed toward children, but accidental pediatric ingestion of melatonin in high amounts is a potential risk, especially with the popularity of dosage formats such as gummies, which are easy to consume and taste good.

A recent study, published in JAMA, found that between 1999 and 2018, the prevalence of melatonin use went from 0.4% in 1999-2000 to 2.1% in 2017-2018. Researchers also determined that consumers taking greater than the 5 mg/day recommended dosage of melatonin increased from 0.08% in 2005-2006 to 0.28% in 2017-2018. The results were based on data from 10 National Health and Nutrition Examination Survey (NHANES) cycles, consisting of 55,021 adults, 52% of which were women, with a mean age of 47.5. Researchers expressed concern about this increased use and the research indicating that some melatonin products may contain more melatonin than their label claims suggest. They also called fore more research on the long-term safety of melatonin consumption.

In response to the JAMA study, the Consumer Healthcare Products Association’s (CHPA; Washington, D.C.) senior vice president, dietary supplements, Duffy MacKay, pointed out that the increased use of melatonin was consistent with the growing use of dietary supplement use more broadly, as a way to manage one’s health, and that self-reported use of melatonin at levels higher than 5 mg/day was very low, indicating that most consumers are taking the product responsibly. Properly manufactured melatonin products should therefore be perfectly safe for consumers when taken properly.

The research on pediatric ingestion of melatonin is important, but not without flaws. As the report states, the research has at least three flaws: “First, poison control center data rely on passive, voluntary, and self-reported case communication that might underestimate actual exposures and lead to selection and information bias. Second, the American Association of Poison Control Centers is not able to confirm the accuracy of each case reported to poison control centers, and individual chart review of all cases could not be performed. Finally, poison control center data do not include patient medical records or medical examiner report, and confirmation of whether a death was secondary to toxic effects solely from melatonin or because of comorbidities was not possible.”

Results should therefore be interpreted carefully, points out Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA; Washington, D.C.). “These deficiencies can lead to hazy and potentially misleading snapshots, which is precisely why the serious adverse event reporting system at FDA via Medwatch was established. Medwatch is the gold standard for detecting and alerting public health officials of potential concerns with products, and so far we have seen no action by the FDA as it relates to Melatonin. Melatonin has been used safely and continues to be under the normal conditions of use as labeled on the product. In the meantime, we remind everyone ­­– including parents with children – who uses dietary supplements to always consult with their doctor or medical professional about what is best for their own personal health and wellness,” said Fabricant in an official statement.

Andrea Wong, PhD, senior vice president of scientific and regulatory affairs at The Council for Responsible Nutrition (CRN; Washington, D.C.) criticized headlines claiming that children were being poisoned by melatonin consumption. “As a toxicologist, I am disturbed by recent headlines claiming melatonin ‘poisoning’ in children rose 530% in 10 years—that is simply inaccurate. These news stories grossly misrepresent the CDC investigation and raise undue alarm," said Wong, in an official statement. "When a parent calls a poison control center about their child possibly ingesting a substance, that call gets counted as an ingestion report regardless of the medical outcome. The mere act of calling a poison control center to inquire about accidental ingestion does not mean that a poisoning or other adverse event occurred."

Wong points to the fact that the vast majority of reports of pediatric ingestion resulted in little to no effect, and those reports of adverse events cannot be reliably linked to melatonin ingestion. “The fact is melatonin is a beneficial dietary supplement that helps to adjust our internal body clocks that regulate sleep and is safe when used as directed," states Wong.“ In addition, news reporting of this increase in ingestion reports that lacks context also misleads parents about the potential dangers. Look at the numbers: Over the last decade, melatonin use has grown exponentially. The Nutrition Business Journal reports the market for melatonin increased 288% in the past five years alone—of course that would correlate with an increasing number of instances where a parent called a poison control center out of an abundance of care and caution."

“Keeping young children safe by preventing them from accidentally ingesting dietary supplements is of the utmost importance to manufacturers...The CDC report appropriately calls for more public education initiatives to prevent accidental unsupervised pediatric exposures to melatonin, such as ‘safe storage’ and ‘appropriate use’ initiatives, and CHPA agrees," offered Duffy MacKay, senior vice president of dietary supplements, for the Consumer Healthcare Products Association (CHPA; Washington, D.C.). "CHPA and our members are involved in a number of long-term efforts targeted at preventing accidental unsupervised ingestions by young children including the Up and Away campaign led by CHPA’s Educational Foundation and the CDC’s PROTECT Initiative, which works to educate and remind parents and caregivers about safe use and storage of healthcare products, always keeping them out of reach and sight of curious, young children."

Updated on July 8, 2022 at 2:16 PM Eastern