- The Council for Responsible Nutrition, the trade association for the dietary supplement industry, announced new guidelines for melatonin product packaging and labeling.
- The announcement follows reports of increases in ER visits and calls to poison control centers for accidental melatonin ingestion among children.
- As demand for melatonin as a sleep aid increases, the possibility for unintended ingestions in young children has experts concerned.
Melatonin manufacturers are being asked by a leading trade organization to improve their product standards over the next 18 to 24 months as demand for this natural over-the-counter sleep aid surges.
On April 15, the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, announced updated guidelines for melatonin supplements that aim to improve formulation, labeling, and packaging.
The voluntary guidelines would also help tighten standards for melatonin gummies to address growing concerns over accidental ingestion and overdose among children.
The CRN announcement follows a recent
However, 94% of these cases did not require hospitalization.
“While we did not assess the clinical effects as a part of this study, a
“In that study, 84.4% of children were asymptomatic,” Lovegrove said.
The Council for Responsible Nutrition has asked melatonin manufacturers to include cautionary language on melatonin product labeling and add child-deterrent packaging to gummies to reduce the risk of unsupervised access.
The proliferation of melatonin use among children over the past decade has experts concerned about the possible short- and long-term effects.
When used as directed, melatonin is generally considered safe — but as with any dietary supplement, melatonin is not held to the same rigorous standards by the Food and Drug Administration (FDA) as over-the-counter or prescription medical drug products.
“We are an industry that depends on the confidence of our consumers,” Steve Mister, president and CEO of the Council for Responsible Nutrition told Healthline.
“If they start to doubt our products or think we’re putting something [unsafe] out there, we’ll lose that consumer. These voluntary guidelines are an example of [the] industry saying we need to do the right thing here — we need to show our consumers that we have their best interest in mind,” Mister said.
A March 2024
The report shows around 11,000 children visited the emergency room between 2019 and 2022 after ingesting melatonin, with nearly 5,000 cases involving melatonin gummies. More than half of all cases involved very young children 3 to 5 years old.
Despite the sharp rise in ER visits, around 94% of these cases did not require hospitalization.
The report also notes a 530% increase in calls to US Poison Control Centers for pediatric melatonin ingestions from 2012 to 2021.
“Among exposures in which symptoms were reported, central nervous system (81.4%), gastrointestinal (10.2%), or cardiovascular (2.5%) effects were the most common,” Lovegrove explained.
Meanwhile, a research letter published in
The authors echo concern over unsupervised ingestions in children tied to melatonin gummies. Lovegrove agreed the differences in ingredients or strength could pose additional risks.
Mister pointed out that melatonin use has increased dramatically in recent years, which could explain the increase in accidental ingestions.
“So this increase in the number of unintended ingestions corresponds with the fact that the market has grown at an even higher rate. So unfortunately, when you have more melatonin in people’s households, you have more opportunities for children to get into it,” Mister said.
While low to moderate melatonin consumption appears safe for adults, less is known about the effects in children.
Until more studies are done, experts say parents of children and adolescents taking melatonin as a sleep aid should talk to their physician and follow pediatric recommendations based on their body weight and age.
Yet melatonin content in dietary supplement products can vary wildly, contributing to growing concern over safety.
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“It’s a little scary to see there’s different products out there that might be more or less effective than they claim to be, and that we’re kind of doing guesswork with our kids,” said Danelle Fisher, MD, FAAP, board certified pediatrician and Chair of Pediatrics at Providence Saint John’s Health Center in Santa Monica, CA.
“And yet, we want something safe and effective to help them with sleep. So I feel [it’s] a difficult situation for caregivers and parents who want their kids to have good and restful sleep,” she told Healthline.
Fisher noted that while melatonin appears safe when used as directed, melatonin gummies that contain additives like CBD or serotonin could harm a child’s developing brain.
“Safety is a big thing — making sure that these kids don’t have access,” Fisher said.
“People are busy and if they leave [gummies] out on the counter, and that kid is able to maneuver the top, they can have as many as they want, not realizing it’s a gummy with medication or a gummy that’s got other substances in it. We have to be really cautious now that we’re opening up the world of these things to the kids.”
Accidental ingestion aside, many children take melatonin to help them sleep, often under the guidance of their pediatrician.
According to the American Academy of Pediatrics (AAP), a low dose of melatonin (0.5 to 1 mg) 30 to 90 minutes before bedtime may be sufficient for many children. Most children should not require more than 3 to 6 mg of melatonin, even those with attention deficit hyperactivity disorder (ADHD).
Before considering melatonin for your child, always consult their pediatrician first. You should never give your child an adult dose of melatonin and choose pediatric-strength products whenever possible.
Fisher said before recommending melatonin to her patients she wants to know whether they’re practicing good sleep hygiene habits such as:
- shutting off screens 30–60 minutes before bedtime
- maintaining a regular bedtime routine
- going to bed at the same time every night
- waking up at the same time every day
“If we need to modify one of those things and get these children to sleep restfully without having to give them a substance, that’s always preferable,” Fisher said.
“Once you’ve determined that their sleep hygiene is good, then if they’re still having issues, I think that melatonin is reasonable — and I usually start with a very low dose, you know, 1 to 2 milligrams in a preschool-aged kid, and usually 3 to 5 mg in older school-aged kids or teenagers. I usually max it [at] 6 mg,” she said.
Fisher recommends children take their melatonin dose 30 minutes prior to bedtime. If they’re taking a gummy product, they should take the gummy followed by a sip of water and then brush their teeth to avoid tooth decay.
“Melatonin is a nice thing to try [but] I’d rather have them not using it if possible,” she said. “Starting with the lowest possible dose and using it in the short term is the safest thing we can do.”
Melatonin, which is a hormone naturally produced by the body to regulate the sleep-wake cycle, is not intended for long-term use as a sleep aid.
The long-term effects of melatonin ingestion are understudied and warrant further investigation.
As such, the CRN recommends melatonin manufacturers include a statement on the label indicating the product is for “intermittent or occasional use only.”
“It should not be used as a crutch for other good sleep habits,” Mister said.
“Your body naturally produces melatonin, so you don’t want to use [melatonin] habitually to the point where your body is relying on your artificial ingestion of melatonin.”
Side effects from melatonin are generally mild and may include mild constipation and daytime drowsiness.
Less is known about melatonin toxicity in adults and children exceeding recommended dosages. The possible side effects of melatonin products containing other ingredients like CBD and serotonin require further study.
If your child accidentally ingests melatonin, you should call a healthcare professional immediately, Fisher said.
Your child’s pediatrician or other healthcare professional can make recommendations about how to monitor your child and any symptoms to look out for, such as:
- lethargy
- decrease in respiratory drive
- slowed heart rate
“Poison Control or your physician will be able to recommend what to do in certain situations,” Fisher said.
“Parents have several avenues they can go if they are concerned about an overdose — and it’s always a good reminder to keep medications out of the reach of children.”
While dietary supplements face less FDA scrutiny than pharmaceutical drugs, product manufacturers are still held to certain standards. For instance, manufacturers of dietary supplements cannot make false health claims.
Both the FDA and the Federal Trade Commission (FTC) oversee how dietary supplement products are
The FDA also requires that dietary supplements contain at least 100% of the labeled amount of the supplement for the duration of the product’s shelf life, the content of which starts to diminish over time, Mister said.
Because melatonin content degrades over time, manufacturers may add more melatonin content to products upon manufacturing to lengthen the shelf life while remaining FDA compliant.
For instance, a product label indicating 3 milligrams of melatonin might initially have 4.5 mg of melatonin, which is 150% of the amount, Mister explained.
For this reason, the new CRN guidelines ask that any overages of melatonin added during the manufacturing process are informed by adequate data to ensure safety. According to Mister, some of the largest melatonin brands are CRN members who’ve agreed to adhere to the new guidelines.
“Melatonin is safe up to 10 milligrams at least — it may be safe even higher,” Mister noted. “Supplements are different because they are vitamins and minerals and herbs that naturally occur in your food. Having a little more, a little less, is not going to hurt you.”
Still, experts like Fisher remain cautious about melatonin use among children.
“I would feel more comfortable as a physician recommending it to my patients if I knew that it was FDA-approved. That is a certain standard to which we hold most of our medications,” Fisher said.
A recent CDC report found a sharp increase in the number of childhood ER visits after accidentally ingesting melatonin supplements and gummies.
In response to growing concern about melatonin safety, the Council for Responsible Nutrition has announced updated guidelines for the melatonin industry to include child-deterrent packaging. These guidelines are voluntary, but the CRN said it expects manufacturers to comply.
The new CRN guidelines aim to improve product packaging for melatonin products, particularly gummies, to make them more difficult for children to get into.
As demand for melatonin as a sleep aid surges, more research is needed to determine safety for both short- and long-term use in children.