Does Melatonin Expire? Adding a Perspective in Drug vs Supplement Debate

Why on earth am I talking about Melatonin in a supplement blog? Most of you have the same hunch in mind. I know you have it!

Before diving deep into the expired melatonin issue, let’s clarify whether Melatonin is a drug or a supplement. Later we can move to whether does melatonin expire.

Is Melatonin A Supplement or A Drug?

You know what? Melatonin is neither a drug nor a supplement. Melatonin is a hormone that your brain produces in response to darkness. So if you are exposed to light at night, it can block melatonin production and hamper sleep.

According to sleep expert Luis F. Buenaver of Johns Hopkins, “Melatonin doesn’t make you sleep, but as melatonin levels rise in the evening, it puts you into a state of quiet wakefulness that helps promote sleep.”

However, across the United States, the FDA considers Melatonin a dietary supplement. What does this mean for you? It implies that the rules and regulations enforced by the Food and Drug Administration (FDA) on Melatonin aren’t as stringent as those for prescription or over-the-counter drugs.

It’s an aspect worth considering when choosing Melatonin as your sleep aid of choice. And here comes the use of Melatonin as a supplement.

Typically made synthetically, melatonin supplements may help with certain conditions, such as

  • Delayed sleep-wake phase disorder
  • Sleep disorders in children
  • Anxiety before and after surgery
  • Jet lag

You can also try natural alternatives like Ashwagandha for sleep and relaxation.

Does Melatonin Expire?

Melatonin supplements have an expiry date; they will start losing their efficacy after passing the date. A study on Melatonin stored in International Space Station (ISS) failed to meet United States Pharmacopeia (USP) requirements 11 months post-expiration.

No wonder Earth’s temperature and humidity fluctuations will expedite Melatonin’s failure to meet United States Pharmacopeia (USP) requirements. It’s not possible right now to say the possible timeframe and rate of expiry without any extensive comparative study.

But it will be better not to use any melatonin supplement 3 months post-expiration if you want to sleep like a baby.

What Happens If You Take Expired Melatonin?

Expired Melatonin is not recommended; however, it poses no serious health risk. If you take expired Melatonin and they are more than 1 year old, you won’t feel any drowsiness or urge to crush on the bed.

If it’s within 3 months of expiry, there can be a few short to medium yawning and a bit of dizziness. That’s it.

Does Melatonin Expire

I know a few who literally asked will I die if I take expired Melatonin. You won’t die, but you won’t be able to sleep, either. Rather stay cautious and check the expiration date before buying or taking any drugs or supplements.

What Happens If You Take Too Much Melatonin? Melatonin Overdose

A melatonin dose ranging from 1 to 5 milligrams is considered safe for adults. But remember, every supplement or medication journey should begin with a chat with your doctor.

If melatonin is on your radar, begin your adventure with the smallest possible dose, gradually upping the ante if required.

Any form of melatonin supplementation of more than 10 mg per day may increase the risk of side effects such as

  • Drowsiness
  • Headache
  • Dizziness
  • Fever
  • Diarrhea

However, a recent study in the Journal of Pineal Research found such side effects of melatonin overdose in only 5% of the cases.

Can I Take Expired Melatonin Gummies?

Like the pills, taking expired melatonin gummies will only make you a bit tired and yawn but won’t make you fall asleep. And taking expired supplements, whether pills or gummies, is still not recommended.

A recent study found a wide range of discrepancies in the labeled quantity of Melatonin in the gummies leading to either over or under-dosages. So, on top of this, if you take an already expired gummy, the outcome won’t be great!

Key Considerations When Thinking About Melatonin

Potential Interaction with Medications

If you’re currently on any medication, it’s essential to consult your healthcare provider before starting Melatonin. This is especially important for individuals with epilepsy or those on blood thinners who should only take Melatonin under strict medical supervision.

Allergic Reactions

Be aware of the potential risk of allergic reactions with melatonin supplements.

Use During Pregnancy and Breastfeeding

The safety of melatonin use in expecting or nursing mothers hasn’t been thoroughly studied. As a result, it’s best to err on the side of caution.

Considerations for Older Individuals

According to the 2015 guidelines from the American Academy of Sleep Medicine, individuals with dementia are discouraged from using Melatonin. Additionally, it may stay active in the system of older individuals longer than in younger ones, potentially leading to daytime sleepiness.

Regulatory Status

In the United States, Melatonin falls under dietary supplements. Consequently, its regulation by the Food and Drug Administration (FDA) isn’t as strict as it would be for a prescription or over-the-counter drug. This differs in many countries where Melatonin is considered a drug and only available with a prescription.

Product Quality

A study conducted in 2017 revealed that some melatonin supplements may not contain the amount listed on their labels. Alarmingly, the same survey found that a significant percentage of supplements tested also contained serotonin, a hormone that can be harmful at relatively low levels.

How Much Melatonin is Equal to Ambien (Zolpidem)?

Considering sleep efficiency and total sleep time, 2.14 mg of prolonged-release Melatonin will give the same outcome equal 10 mg of Ambien (Zolpidem).

Melatonin (2 mg)Ambien (10 mg)
Sleep Efficiency (%)84.5190.22
Total Sleep Time (min)405.61433.10
Source: Journal of Psychopharmacology

A recent randomized clinical trial found that prolonged-release melatonin has a minor effect on night-time sleep than zolpidem. This is probably because these two medications work in different ways.

How Long Does Melatonin Last in Your Body?

Fast-release Melatonin has less than 30 minutes half-life and a ready metabolism after oral administration. However, the prolonged released melatonin preparation has an extended half-life of up to 4 hours, and metabolism is slow.

So how long does melatonin last in your body depends on whether you are taking the fast-release or extended-release version of the sleep aid.

The fast-release version will start working instantly and leave your body quickly. On the contrary, the slow-acting ones will take time to make you sleep and stay longer in your body.


Sleep is crucial, and choosing wisely can help ensure your sleep health remains top-notch!

Like any other supplement, Melatonin expires, affecting its efficacy. Choosing the right sleep aid requires informed decision-making.

Understanding Melatonin’s unique nature is essential as neither a drug nor a supplement but a hormone. It’s vital to weigh the benefits and potential risks, consider its interactions with medications, and be cognizant of its less stringent regulations.

For more in-depth insights on Melatonin and other dietary supplements, check out Supplement Salon, your go-to resource for all things supplement-related.

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