Note: The U.S. Food and Drug Administration (FDA) does not approve supplements for safety or effectiveness. Talk to a healthcare professional about whether a supplement is the right fit for your individual health, and about any potential drug interactions or safety concerns.

Sleep gummies, supplements in gummy form with a range of active ingredients, may be an effective short-term treatment, says Keri Gans, RDN, a nutrition consultant in New York City and the author of The Small Change Diet.

As the name suggests, sleep gummies are supplements in gummy form that are intended to help you fall and stay asleep. These products are relatively new and part of what Michael Breus, PhD, a clinical psychologist in Manhattan Beach, California, who specializes in sleep disorders, calls the “gummy craze” sweeping the supplements industry.

Sleep gummies contain active ingredients to induce sleep, most commonly melatonin, L-theanine, magnesium, and cannabidiol (CBD). Perhaps the only benefit sleep gummies have over supplements in capsule or tablet form is that they’re easier to consume for people who cannot swallow pills, says Dr. Breus, who is also the author of The Power of When, a book on understanding your body clock and circadian rhythms.

These over-the-counter sleep aids usually use one or a combination of four major ingredients to help induce sleep: melatonin, L-theanine, magnesium, and CBD.

Melatonin

L-theanine

Magnesium

CBD

The biggest benefit of sleep gummies is that they may help you fall asleep faster and stay asleep for longer. Since sleep gummies are relatively new to the market and formulations vary so significantly, there aren’t specific studies supporting their benefits. However, research does explore the efficacy of the active ingredients they commonly feature.

Experts unanimously point out that any potential benefits of sleep gummies are only a short-term solution. These supplements don’t treat the root cause of sleeplessness.

The biggest issue with sleep gummies is that, like all dietary supplements, they’re not regulated in the United States.

“Since the passage of the federal Dietary Supplement Health and Education Act (DSHEA) of 1994, any product labeled as a dietary supplement escapes U.S. Food and Drug Administration (FDA) regulation,” says Carl Baum, MD, a professor of pediatrics and emergency medicine at the Yale School of Medicine in New Haven, Connecticut. “Other pharmaceuticals, including over-the-counter products, require evidence of safety and efficacy before they are approved by the FDA.” This means that once a product enters the market, the FDA bears the burden of proving whether it’s mislabeled or dangerous before it can be withdrawn from the market.

“The bottom line is that if you take a dietary supplement, you have absolutely no idea what’s in the product,” he says. “The active ingredient may not be present in the labeled dose — if it’s there at all — and disclosure of contaminants and adulterants isn’t required.”

Breus also notes that, as a general rule, “you can put more stuff in a gummy than a pill,” including sugar, flavoring, and other unnecessary ingredients. “This can easily lead to overdosages,” he says. “Very few, if any, supplements actually have the correct dose of any herb or supplement.”

Additionally, any product in gummy form may lead to what Breus calls candy confusion. “We’re seeing lots of accidental overdoses and kids taking things thinking they’re candy,” he says.

Drug interactions are also a potential risk, notably with sleep gummies containing melatonin, magnesium, CBD, or a combination thereof. “If you’re on any prescribed medications or have any medical conditions, you should always check with your physician first before starting on any supplements,” says Gans.

If your doctor gives you the go-ahead to take sleep gummies, be sure to take them as directed. Most gummies should be taken shortly before bedtime. If you take them in the morning or afternoon, you may become drowsy.

How long the effects of sleep gummies last depends significantly on the active ingredients they contain, the dose of these ingredients, and how an individual’s body metabolizes them. Even so, research is both limited and inconsistent in reporting the duration of the effects of common over-the-counter sleep aid supplements.

Because sleep gummies aren’t regulated by the FDA, Gans stresses the importance of choosing a product from a reputable brand. “Always choose a supplement that has third-party certification,” she says. The National Sanitation Foundation International (NSF) and the U.S. Pharmacopeia (USP) are two reputable third-party certification groups.

Next, read product labels carefully, paying particular attention to the active ingredients of sleep gummy products you’re considering. Always consult your healthcare provider before taking these supplements to assess potential benefits and risks specific to you and your overall health.

• Sleep gummies are over-the-counter supplements designed to help users fall and stay asleep using active ingredients like melatonin, L-theanine, magnesium, or CBD.
• While sleep gummies offer a palatable alternative for those who struggle to swallow pills, experts emphasize that they’re only a short-term solution and don’t address the root causes of chronic insomnia.
• Because the FDA doesn’t regulate these supplements for safety or efficacy, products may contain inconsistent doses, hidden contaminants, or high amounts of sugar and flavoring.
• Before use, it’s critical to consult a healthcare provider regarding potential drug interactions and to choose products with third-party certifications, such as USP or NSF, to ensure ingredient accuracy.