What's in the bottle

Is melatonin FDA approved?

By GyroscopeUpdated November 14, 20267 sources

No. In the US melatonin is a dietary supplement, and by law the FDA doesn’t approve dietary supplements or their labeling before they’re sold. The company that makes it is responsible for what’s in the bottle. In several other countries, melatonin is a prescription drug.

Melatonin sits in the pharmacy next to the cold medicine, with dosing on the label, so it’s easy to assume someone checked it. Under the federal law that covers supplements, the FDA doesn’t have the authority to approve them before they’re marketed. The agency mostly steps in after a problem product is already on shelves.

We’d buy plain tablets from a brand that has each batch tested by an outside lab, and treat the number on any gummy as a rough guide.

It’s like buying from a bake sale. The baker is responsible for what’s in it, and nobody tested it before it went on the table.

What that means in the bottle

When researchers measure what’s inside, the labels often miss. In a 2023 test of 25 US melatonin gummy products, 22 didn’t match their label. One had no melatonin, and the rest held 74 to 347 percent of the labeled amount. A 2017 Canadian study of 31 supplements found melatonin from 83 percent below the label to 478 percent above it, and serotonin in 8 of them. Are melatonin gummies accurate? has the full table.

What the US sleep doctors say

The American Academy of Sleep Medicine’s 2017 guideline for long-term insomnia in adults suggests doctors don’t use melatonin to treat it, and calls that a weak recommendation. The same academy’s 2015 guideline supports melatonin taken at a set hour for people whose body clock runs very late. The evidence is thin for melatonin as a sleeping pill for long-term insomnia, and better for moving a late body clock when it’s taken at the right hour.

Sales went up fast

US melatonin sales grew from $285 million in 2016 to $821 million in 2020, according to the CDC’s 2022 report on children swallowing it. Over those same years, the number of children and teens reported to poison centers after swallowing it kept climbing every year.

Outside the US

Outside the US, melatonin is often prescription only, so check your own country’s rules.

If you take a prescription medicine every day, ask your prescriber before adding any supplement, melatonin included. The medicines answer lists the interactions that have been measured.