During a period beginning in 2012 and ending in 2021, the number of annual reports of pediatric ingestion of melatonin increased 530% with a total of 260,435 ingestions reported. There was a correlated increase in pediatric hospitalizations and more serious outcomes, primarily because of an increase in unintentional melatonin ingestion in children five years old and younger, the CDC reported.

Of all reported melatonin ingestions, 4,555 (1.6%) resulted in more serious outcomes. Five children required mechanical ventilation, and two died. This data came from a cross-sectional study of pediatric melatonin ingestion reported to U.S. poison control centers.

Melatonin, a popular ingredient found in dietary supplements, became the most frequently-ingested substance among children reported to national poison control centers in 2020, the CDC researchers wrote, with the largest annual increase in pediatric melatonin ingestions occurring during the onset of the COVID-19 pandemic.

“This might be related to increased accessibility of melatonin during the pandemic, as children spent more time at home because of stay-at-home orders and school closures,” study authors wrote. “Further, reports of increasing sleep disturbances during the pandemic might have led to increased availability of melatonin in the home.”

The authors noted that hospitalizations and more serious outcomes due to melatonin ingestions have increased in children, potentially due to variability of melatonin content across products.

The authors noted the study findings are subject to certain limitations. Poison control center data rely on passive, voluntary, and self-reported case communication that might underestimate actual exposures. Additionally, the American Association of Poison Control Centers is not able to confirm the accuracy of each case reported to poison control centers, and so individual reviews of cases could not be performed. Further, this observational data did not include patient medical records or a medical examiner report, so confirmation of whether a death was related to melatonin solely, or because of other comorbidities, was not possible.

Medical Data, Comorbidities Not Included in Reporting

Reporting on this CDC study seemed to conflate melatonin “poisoning” with calls to U.S. Poison Control Centers involving melatonin, according to Andrea Wong, PhD, senior vice president of scientific and regulatory affairs at the Council for Responsible Nutrition (CRN).

She argued this could certainly mislead consumers, as what rose 530% according to the data was ingestion reports, regardless of any medical outcome. Ninety-eight percent of the reports in the CDC study were linked to either no effect or a minor effect, and 83% of children were completely asymptomatic after melatonin ingestion—cases which certainly do not constitute “poisoning,” she noted.

Among several stories which reported the data similarly, one headline from Forbes reads “Melatonin Poisoning Reports Among Kids Up 530% from 2012 To 2021,” and a headline from a U.S. News & World Report study reads “Melatonin Poisoning Cases Soaring Among U.S. Kids.” In the later story, it was reported that “the number of kids accidentally poisoned by the over-the-counter sleep aid melatonin has soared 530% over the past decade.”

“As a toxicologist, I am disturbed by recent headlines claiming melatonin ‘poisoning’ in children rose 530% in 10 years,” Wong said. “That is simply inaccurate. These news stories grossly misrepresent the CDC investigation and raise undue alarm. 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.”

“For the few reports associated with an adverse outcome, it is not possible to confirm whether the outcomes were caused by melatonin ingestion since poison control data does not include patient medical records,” Wong continued.  She noted that the increase in ingestion reports also correlates with increased use of melatonin, which, according to CRN’s consumer survey data, rose from 5% of adults in 2012 to 11% of adults in 2021. Additionally, she cited Nutrition Business Journal’s report that melatonin sales 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,” Wong said.

Nonetheless, she emphasized the importance of using melatonin, like all other dietary supplements, safely and as directed, and to keep melatonin out of the reach of children.

“As a toxicologist—and a parent—I took two key points from the CDC research: First, parents should talk to their children’s healthcare providers about whether melatonin supplements may be helpful, the appropriate dose, and duration of use,” Wong said. “Also, parents must remember to keep all supplements out of children’s reach and to follow the directions for use on the label.”

The Natural Products Association (NPA), in its response, also noted that more reliable data exists regarding potential problems with dietary supplement products. 

“This is an important finding, but officials need to ensure that they have the most accurate data regarding melatonin,” NPA stated. The lack of data on medical outcomes, comorbidities, and individual data “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 and 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,” NPA continued.