Melatonin: Dietary supplement or hormone product?

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“Go to bed late, stay very small. Go to bed early, grow very tall.” This popular nursery rhyme encourages children to get the rest their bodies need so they’ll grow big. For many Americans, however, sleep is elusive, more a wish than a reality. According to the American Sleep Apnea Association, between 50 million and 70 million American adults have sleep disorders.¹

Of those, many individuals reach for over-the-counter medicine or get prescription sleeping pills. Others seek out natural sleeping aids, turned off by the side effects or uninterested in traditional medical solutions. One of the most popular natural sleep aids today is melatonin.

Melatonin is a hormone that the body produces to help regulate one’s circadian rhythm. It is produced in the brain and may play other important roles beyond sleep regulation, with research continuing around these other uses.

Melatonin: Dietary Supplement or Hormone Product?

Should melatonin be treated as a dietary supplement or as a hormone product? David Foreman is president of Herbal Pharmacist and says he believes without a doubt that melatonin should not be sold as a dietary supplement. “Melatonin is a hormone, period. Whatever the source, if it is just melatonin, it is a hormone,” says Foreman. “Hormones are sold as drugs normally, and I have no idea how we are allowed to sell a hormone and consider it a dietary supplement.”

The American College of Obstetricians and Gynecologists (ACOG) notes two products which are compounded bioidentical hormone products. One is micronized progesterone and the other estradiol. Both are approved by FDA.² “Bioidentical hormones are plant-derived hormones that are chemically similar or structurally identical to those produced by the body,” states AGOG’s website.²

“Currently, melatonin is considered a dietary supplement as regulated by the FDA,” says Jeff Ventura, vice president of communications at the Council for Responsible Nutrition (CRN; Washington, DC). “What regulatory category a product falls under depends on how the company that makes it decides to bring it onto the market,” Ventura points out. “If, for example, a company considers their melatonin product to be a supplement, they may choose to bring it to market under that route, or pathway, adhering to the regulations set forth in the Dietary Supplement Health and Education Act (DSHEA).”

Best Practice: Marketing Melatonin Responsibly

CRN offers recommended guidelines for the labeling and formulation of melatonin-containing dietary supplements. These include complying with all applicable labeling laws and regulations, as well as formulation guidelines. The association’s website notes, “. . . dietary supplements containing melatonin and marketing for sleep support should be formulated and labeled to provide not more than 10 mg of melatonin per day when used in accordance with the directions for use.” The guidelines also specify that manufacturers should note potential side effects of the supplement as well as a warning not to operate machinery when taking it.

Foreman says that melatonin should not be marketed as a supplement, period. “While research seems to show it is safe and has efficacy, it is still a hormone and we shouldn’t supplement with hormones,” he states. “A better way to address melatonin for sleep is by consuming either botanicals with very low levels of naturally occurring melatonin as part of their phytochemical makeup, or by consuming supplements—like saffron—which have been proven to support the body’s natural production of the hormone.”

The Mayo Clinic refers to melatonin as “generally safe” but recommends it for short-term use only. The medical facility encourages individuals to use melatonin under their doctor’s supervision and to use it as one would any sleeping pill.

References

1. American Sleep Apnea Association. The state of sleep health in America 2023. https://www.sleephealth.org/sleep-health/the-state-of-sleephealth-in-america/#:~:text=If%20you're%20having%20sleep,need%20to%20protect%20their%20health.
2. The American College of Obstetricians and Gynecologists. Compounded bioidentical menopausal hormone therapy. Committee Opinion No. 532. Obstet Gynecol. 2012;120:411–415. https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2012/08/compounded-bioidentical-menopausal-hormone-therapy