MELATONIN IN THE NEWS

There is a growing trend in the consumption of gummy supplements, including melatonin gummies. This has sparked concerns about the safety and efficacy of gummy supplements. While there are several ways to consume melatonin, oral administration is the only format available in the U.S. as a dietary supplement (1). In the oral format, there can be many delivery forms included, such as the following:

• Capsules

• Chewable tablets

• Chocolates

• Gummies

• Liquids

• Powders

• Softgels

• Sprays

• Tablets

 

People may prefer powders or gummies because of their taste or ability to swallow. In 2018, it was reported that 48% of all melatonin products were in capsule form, 22% in tablets, 14% in powders, 11% in liquids, and 5% in all other forms (including gummies at 0.8%) (2). However, this trend has changed drastically, with 48.4% of all melatonin products sold on Amazon in gummy format, 36.3% in flavored chewable, and 15.4% in other formats. (B. Sample, email communication, October 5, 2022)

 

This review will discuss some concerns about melatonin gummies.

 

Concern #1-Gummies look and taste like candy.

 

It should not be surprising that 70% of multivitamin-mineral supplements are in gummy form for the pediatric population, followed by chewable tablets at 29% (3). Approximately 65% of gummy-formulated supplements are marketed toward children (4). Clearly, a gummy or chewable form of melatonin (or any other supplement) would be easy for children to consume compared to swallowing a capsule or tablet. It also is visually appealing to children and can be pleasing to eat because gummies look and taste like candy. Parents should take caution to avoid calling melatonin “candy” or “vitamins” to get children to take it, as doing so can lead to potential misuse or overuse of the supplement (5). Further, this form can promote the use of melatonin supplementation when it may not be needed. Children naturally produce higher amounts of melatonin to promote more sleep, making its application for children limited to certain conditions such as ADHD or autism (1). 

 

When searching specifically for melatonin supplements for kids on Amazon, 76 products were available, with most containing imagery or wording appealing to children. For example, many bottles or boxes use primary colors that are often associated with kid-friendly items, images including cartoon-like animals such as sheep and teddy bears, and wording such as “nighty-night.”  Additionally, like most supplements, melatonin supplements are not packaged to be child-proof.

 

This point brings us to another concern about melatonin gummies: the potential overdose or misuse of melatonin, especially by children.

 

Concern #2- Overdose or misuse in the pediatric population

 

The CDC has reported that from 2012-2021, a total of 260,435 reports of pediatric melatonin ingestion were reported nationally to poison control centers---most of them were unintentional (94.3%). While most children were asymptomatic (84.4%), the remaining 15.6% were symptomatic, which included gastrointestinal, cardiovascular, or nervous system symptoms (6). Some common symptoms include headaches, feeling groggy, also sometimes called a “melatonin hangover,” or severe sedation.

 

In 2021, a retrospective study (4), including children ages 0-19, was conducted over three years to examine exposure specifically to gummy-formulated medications as identified by calls made to the Regional Poison Control Center in Alabama. The medication list was classified into four categories: vitamins, minerals and supplements, melatonin, and others. This study reported the following:

• 24.1% of the calls were in response to the ingestion of gummy melatonin.

• Children had 8.4 times higher odds of being symptomatic when gummy melatonin was ingested (this finding was statistically significant).

• Children had 4.8 times higher odds of visiting an emergency room when gummy melatonin was ingested (this finding was statistically significant).

 

Why are children unintentionally ingesting melatonin? This question brings us to the next challenge.

 

Concern #3- Added sugars/sweeteners

 

Most people don’t realize the immense quantity of sugar the average person ingests daily. Estimates from the Centers for Diseases Control and Prevention (CDC) indicate that the average American (adults and children 2 years and older) consumes 17 teaspoons of sugar each day.  This amount includes hidden sources of sugar, such as condiments and dressings, packaged foods, such as cereals or cereal bars, and certain forms of supplements, such as gummies.  The American Heart Association suggests limiting sugar intake to less than 6 teaspoons per day for women and children and less than 9 teaspoons for men.  Whereas the Dietary Guidelines for Americans, 2020-2025, the CDC recommends limiting sugar to less than 10% of daily caloric intake. (With an intake of 2,000 calories per day, this would be less than 12 teaspoons per day.) Children under the age of 2 should not consume any added sugars.

 

Added sugars or sweeteners are used in gummy delivery to make it tasty and especially appealing to children. While it is not the only ingredient used, sugar (including corn syrups and sucrose) can contribute to the “shiny” coat often found on gummies, while dextrose can be used to help control moisture retention and texture (7).   

 

Sweeteners that may be included in gummy supplements can include, but are not limited to:

• artificial sweeteners (aspartame, saccharin, sucralose). If something is labeled “sugar-free,” check for these ingredients.

• cane juice

• sugar (Do not be misled by “organic sweeteners,” such as organic cane sugar. This is still sugar.)

• sugar alcohols (e.g., erythritol, maltitol, mannitol, xylitol)

• syrups, such as corn syrup, tapioca syrup, glucose syrup

 

Our independent review was conducted on 20 gummy melatonin supplements available for purchase on Amazon. The labels revealed that gummy melatonin supplements contain between 1-8 grams of sugar per serving. This amount is up to 2 teaspoons of sugar per serving, with the average being nearly 4 grams or one teaspoon of sugar per serving! The cumulative intake of sugar by taking melatonin gummies with 4 grams of sugar could be:

• 7 teaspoons per week

• 30-31 teaspoons per month

• 365 teaspoons per year

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It is important to note that sugar alone can impair the quality of sleep. Studies in both children and adults suggest that consuming sugar can contribute to disrupted sleep throughout the night, resulting in feeling unrefreshed upon waking (8,9). Additionally, based on the body’s digestive and glucose regulation processes, consuming food, including sugar, 2-3 hours before bedtime can impair one’s ability to fall asleep. Neither children nor adults benefit from consuming sugar before sleep.

 

Concern #4- Added fillers and excipients

 

There are a number of fillers and excipients that can be used in the manufacturing of supplements. You will typically find these listed in the “other ingredients” are of the label. This can include binding, gelling, and coating agents, preservatives, colors/dyes, flavors, and sweeteners. The addition of dyes, flavoring agents, and other excipients are needed for the texture, taste, and form of gummies. For example, dyes give the supplement its coloring, natural or artificial flavoring will provide the taste, and gelling agents provide texture and help to set the product quicker (7).  

 

Gummies come in various colors and flavors, with blended fruit flavors holding popularity with kids and adults alike. However, these colors and flavors must come from somewhere. Currently, there are seven Foods, Drug & Cosmetic dyes approved for use in foods and supplements, resulting in the colors “Tartrazine,” Allura Red,” “Indigo Carmine,” “Brilliant Blue,” “Fast Green,” “Erythrosine” and “Sunset Yellow.” (10). A report from the state of California, released in April 2021, confirmed that “synthetic food dyes can cause hyperactivity and other neurobehavioral issues for some children.” (11).

 

Flavoring agents are used to provide the taste one might expect from the color of the gummy. For example, a bright red gummy might taste like cherry. This chemical processing requires ongoing cooking, heating, and forming techniques that are both time-consuming and expensive to get the result of gummy melatonin. The flavoring agents used may be derived from artificial or natural sources.

 

Gelatin is an animal-based excipient that can be used in gummy formulas as a coating and gelling agent. This is what gives it the classic chewy, elastic-like texture. Vegetarians and vegans will want to be mindful of this ingredient since it is animal-based.  The bigger concern is that the presence of gelatin will make the supplement more susceptible to melting when exposed to heat (7). Let’s say the melatonin gummy is left near a window or in the car with the sun beating down. The melting of the gummy can result in unexpected melatonin levels in what is left of the gummy after it has melted. This can be especially concerning for children, and adults alike, as the label claim for the dose can then be altered, causing a potential for the ingestion of higher amounts of melatonin and possible toxicity or overdose concerns. It is worth noting that sugar-free formulas will use more gelatin than their sugar-containing counterparts (7).

 

Additionally, if the gummy supplement is in a sustained or extended-release format, they may utilize a variety of non-desirable, toxic coating agents, such as phthalates, to slow absorption (12). This is noteworthy, as phthalates are known endocrine disruptors, which is a compound that can interfere with the body’s hormones. As a reminder, melatonin is a hormone.

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Concern #5- Quality

 

As with all supplements, choosing a supplement company that adheres to good manufacturing practices (GMPs) will help ensure you choose a supplement that abides by strict quality assurance guidelines. Melatonin is no exception. 

 

Multiple studies have reported on various quality issues, from potency to label claims, to the presence of adulterants and contaminants. For example, presently, 99% of supplemental melatonin is synthetic, derived from chemical synthesis, often involving petrochemicals, with the potential for dosing, quality, and adulteration issues (up to 13 different contaminants) (1). An analysis of 31 melatonin supplements reported that the melatonin content ranged from 17% to 478% of what was listed on the label, with a lot-to-lot variability of up to 465% (13). This not only brings concerns about label claims but raises concerns about possible toxicity or overdosing, especially in the pediatric population.

 

Testing was conducted by ConsumerLab.com on many forms of gummy supplements and found that some had much higher or lower amounts of the ingredients listed on the label, raising quality concerns.

 

Melatonin can also degrade in the presence of light and air, making oxygen-barrier blister packs an ideal packaging option over an open bottle format. Further, melatonin may react with moisture. The gummy hygroscopic matrix (high in water content) may make this format of melatonin more susceptible to oxidation, raising additional delivery and quality concerns (1).

 

Conclusion

As you can see, several concerns arise using gummy melatonin, including the sugar and sweeteners used, the added dyes, flavoring, or other excipients, and the overall quality of most melatonin supplements. If melatonin is needed, aim for a high-quality supplement that is non-toxic, free of sugars/sweeteners, dyes, flavoring agents, and excipients.  For those who choose gummy melatonin because of difficulty swallowing capsules, consider opening the capsule and sprinkling it on food, such as plain yogurt, unsweetened applesauce, or added to a nutrient-rich smoothie.

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References

1. Minich DM, Henning M, Darley C, Fahoum M, Schuler CB, Frame J. Is Melatonin the “Next Vitamin D”?: A Review of Emerging Science, Clinical Uses, Safety, and Dietary Supplements. Nutrients. 2022;14(19). doi:10.3390/nu14193934

2. Saldanha LG, Dwyer JT, Bailen RA, et al. Characteristics and challenges of dietary supplement databases derived from label information. J Nutr. 2018. doi:10.1093/jn/nxy103

3. Ethan D, Basch CH, Samuel L, Quinn C, Dunne S. An Examination of Product Packaging Marketing Strategies Used to Promote Pediatric Multivitamins. J Community Health. 2015. doi:10.1007/s10900-014-9972-1

4. Crawford EB, Coco T, Gaines LD, Shah N, Slattery A. Pediatric ingestions with gummy formulated medications: a retrospective study. Clin Toxicol. 2021. doi:10.1080/15563650.2020.1822532

5. Kuehn BM. Climbing Melatonin Use for Insomnia Raises Safety Concerns. Jama. 2022;328(7):605-607. doi:10.1001/jama.2022.11506

6. Lelak K, Vohra V, Neuman MI, Toce MS SU. Pediatric Melatonin Ingestions - United States, 2012-2021. Morb Mortal Wkly Rep. 71(22):725-729. doi:doi:10.15585/mmwr.mm7122a1

7. Burg J. Generating yummy gummies. Natural Products INSIDER. https://www.naturalproductsinsider.com/specialty-nutrients/generating-yummy-gummies. Published 2020. Accessed October 6, 2022.

8. Shih YH, Wu HC, Pan WH, Chang HY. The Association Between Frequent Sugar-Sweetened Beverage Intake and Sleep Duration in School Children: A Cross-Sectional Study. Front Nutr. 2022;9(March):1-11. doi:10.3389/fnut.2022.847704

9. Alahmary SA, Alduhaylib SA, Alkawii HA, et al. Relationship Between Added Sugar Intake and Sleep Quality Among University Students: A Cross-sectional Study. Am J Lifestyle Med. 2022. doi:10.1177/1559827619870476

10. Lehmkuhler AL, Miller MD, Bradman A, Castroina R, Mitchell AE. Certified food dyes in over the counter medicines and supplements marketed for children and pregnant women. Food Chem Toxicol. 2020. doi:10.1016/j.fct.2020.111499

11. New report shows artificial food coloring causes hyperactivity in some kids. Berkeley Public Health.

12. Li Y, Zhao X, Zu Y, et al. Melatonin-loaded silica coated with hydroxypropyl methylcellulose phthalate for enhanced oral bioavailability: Preparation, and in vitro-in vivo evaluation. Eur J Pharm Biopharm. 2017. doi:10.1016/j.ejpb.2016.11.003

13. Erland LAE, Saxena PK. Melatonin Natural Health Products and Supplements: Presence of serotonin and significant variability of melatonin content. J Clin Sleep Med. 2017. doi:10.5664/jcsm.6462

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