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High Dose Melatonin Side Effects

Do Melatonin Supplements Actually Help You Sleep Better

Side Effects of Melatonin: What Are the Risks?

The answer is that it dependsin this case, it depends on whats happening in your body thats keeping you from getting tired and falling or staying asleep.

If youre not producing enough melatonin, like those with circadian rhythm disorders it can be effective. A circadian rhythm disorder, according to the National Institutes of Health, are problems that occur when your bodys internal clock, which tells you when its time to sleep or wake, is out of sync with your environment.

Michelle Drerup, Psy.D., a psychologist with the Sleep Disorders Center at the Cleveland Clinic, who treats patients suffering from sleep issues, says melatonin supplements can be helpful for addressing sleep concerns when you need to shift the timing of your sleep cycle. For example, if youre experiencing jet lag from travel, melatonin may offer an effective strategy for getting you back on a particular time zone, Drerup says. Dreup also says melatonin may help align the natural circadian rhythm for those who work a night shift.

However, while melatonin can help you fall asleep in these cases, it doesnt mean itll help you stay asleep, she says.

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Side Effects Of Melatonin: What Are The Risks

Melatonin is a hormone and dietary supplement commonly used as a sleep aid.

Although it has an outstanding safety profile, melatonins growing popularity has raised some concerns.

These concerns are mainly due to a lack of research on its long-term effects, as well as its wide-ranging effects as a hormone.

This article reviews the potential side effects of melatonin supplements.

Melatonin is a neurohormone produced by the pineal glands in your brain, mainly at night.

It prepares your body for sleep and is sometimes called the hormone of sleep or hormone of darkness.

Melatonin supplements are frequently used as a sleep aid. They help you fall asleep, improve sleep quality, and increase sleep duration. However, they dont appear to be as effective as many other sleep medications .

Sleep isnt the only body function melatonin affects. This hormone also plays a role in your bodys antioxidant defenses and helps regulate blood pressure, body temperature, and cortisol levels, as well as sexual and immune function .

In the United States, melatonin is available over the counter. Since June 2021, it has also been available over the counter in Australia for people over 55 .

In contrast, its a prescription drug in most European countries and approved for use only in older adults with sleep disorders (

However, the Food and Drug Administration has neither approved its use nor evaluated its safety in children.

How Do Melatonin Supplements Work

The pineal gland in the brain is responsible for natural melatonin production in the body. It doesnt make you sleepy, but as melatonin levels rise in the evening, it puts you into a state of quiet wakefulness that helps promote sleep, explains Johns Hopkins sleep expert Luis F. Buenaver, Ph.D., C.B.S.M.

Taking melatonin can help with a range of sleep problems such as:

  • Primary sleep disorders like insomnia
  • Delayed sleep-wake disorder
  • Sleep problems in children with autism spectrum disorder or attention deficit hyperactivity disorder

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Lower Melatonin Doses Show Better Effects

It is advisable to use the lowest possible dose of melatonin with an immediate release formulation for older adults, from 0.3 mg to a maximum of 1 or 2 mg, preferably 1 hour before bed. This best mimics the physiological circadian rhythm of melatonin and avoids long-lasting blood levels above the physiological level.

It has also been shown that higher doses of orally ingested melatonin cause a prolonged increase in melatonin levels. Gooneratne et al. showed that a higher dose in a 75% sustained release formulation compared to a lower dose caused a substantial prolongation of the elevated melatonin levels during the morning and during the day.

Zhdanova et al. also found that melatonin levels in the high dose group were maintained above a set threshold for longer than in the low dose groups . This means that a higher dose carries the risk of prolonging the supra-physiological levels in older adults during the next day. This could lead to problems with side effects such as dizziness, drowsiness or a restless feeling when waking up, despite the low toxicity of melatonin.

Studies also looked at additional effects of melatonin administration on other outcomes, such as sleep and core body temperature. Oral melatonin had a positive effect on sleep parameters. Some studies showed that with higher doses and prolongation of the supra-physiological levels, melatonin loses its effectiveness on sleep parameters and with lower doses regains its effectiveness.

Are Melatonin Supplements Safe

10 Dangers of Melatonin

A Michigan Medicine expert explains what we know and dont know about the hormone supplement thats growing in popularity.

Sleep is essential in the pursuit of a long, healthy life. While some of us are habitual in our sleep-wake schedules, a lot of us probably arent. And more and more often, people are reaching for a melatonin supplement to improve sleep quality or duration.

A Michigan Medicine sleep expert says that while these supplements are generally safe and can be helpful, they arent as magical as some people make them out to be.

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If taken at the appropriate time and dosage, melatonin is great for jet lag and helping night owls to fall asleep earlier, says Leslie Swanson, Ph.D., clinical associate professor in psychiatry at Michigan Medicines Sleep and Circadian Research Laboratory.

Although melatonin has its benefits, Swanson notes that studies have shown minimal improvement in sleep for people with insomnia after taking a supplement. On average, results show a seven-minute decrease in the time it takes to fall asleep.

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Whats The Highest Dose Melatonin Tested On Animal Models

I havent spent much time digging into the animal data. A cursory search led me to StatPearls .

800 mg/kg: Apparently researchers havent been able to discover an LD50 for melatonin in animals. A dosage of 800 mg/kg was NOT fatal.

Although this dosage cannot be directly extrapolated to humans, lets determine how much this would be for an average adult American male .

This would equate to taking a melatonin dose of 71.76 grams without dying .

Does Melatonin Have Side Effects

Very few people have problems with melatonin. Despite the large number of people taking melatonin in the United States, only a few side effects have been reported to the FDA.

Melatonin is very safe when taken for a short time. It can also be safe for some people to take it long term. Melatonin was taken without problems over a period of up to two years.

Melatonin has low toxicity and is generally well tolerated. However, sensitive people can experience the following side effects:

  • vivid dreams or nightmares

Pregnant or breastfeeding women should not take melatonin. Melatonin is a hormone So if you have or have had hormonal health problems, you should only use melatonin under the supervision of a doctor.

No motor vehicles or machines should be operated up to five hours after taking melatonin.

If you intentionally or accidentally take an overdose of melatonin, you should see a doctor immediately.

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Melatonin Side Effects And Safety 101

Before you take melatonin for better sleep, make sure you understand the potential side effects.

Cant sleep and looking for a non-habit-forming sleep aid?

Its not unusual to deal with insomnia from time to time. You may have difficulty falling asleep. Or if youre able to fall asleep quickly, you may wake up after two or three hours. This can cause daytime sleepiness, irritability, and decreased productivity.

One night of bad sleep might not wreak too much havoc on your body. But when the problem goes on for days, weeks, or months, supplementing with melatonin can get your sleep back on track.

Melatonin is a hormone that your body makes naturally. Your melatonin level increases a couple of hours before bedtime, which signals your body to prepare for rest. Its important to note, however, that melatonin isnt a sleep initiator but rather a sleep regulator, explains Carolyn Dean, MD, a sleep expert and author of 365 Ways to Boost Your Brain Power: Tips, Exercise, Advice.

Some people, however, dont produce enough melatonin. And as a result, sleep doesnt come easily. But while melatonin is a natural hormone that can help reset your circadian clock, oral melatonin isnt right for everyone.

Melatonin And Advanced Cancer

Taking melatonin comes with risks

In the unfortunate circumstance in which cancer has already overwhelmed the bodys innate cancer-fighting capabilities, including the anti-cancer activity of naturally produced melatonin , supplemental melatonin may be beneficial. Melatonin plays a critical role in the host defense system against cancers progression by activating the cytokine system, which exerts growth-inhibiting properties, and by stimulating the cytotoxic activity of macrophages and monocytes.

Numerous European clinical studies already have examined melatonins therapeutic benefits to patients with different types of cancer who either did not respond to standard oncological therapies or were eligible only for supportive care .

Administration of supplemental melatonin has been shown to be beneficial even in the supportive care of advanced and end-stage cancer patients: it lessens tissue wasting and diminishes weight loss, fatigue, weakness, and depression enhances immune function improves wound healing and improves quality of life and survival rates.

Furthermore, melatonin improves common symptoms found in both patients with advanced cancer and those undergoing chemotherapy it counteracts anemia and lymphocytopenia, stimulates platelet production, enhances appetite, and diminishes cancer pain through its natural analgesic properties. These are substantial benefits considering that approximately half of all patients diagnosed with cancer die because of poor symptom management.

Ultra Melatonin

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For Babies And Children

Melatonin is a popular supplement for children. After multivitamins, melatonin is the most common natural product that parents give to their children. Like infants, babies and children may be able to use melatonin safely, but its use should be closely monitored by a healthcare provider, who can determine the dosage.

When using melatonin for a child, always keep the supplement out of reach and locked away. Research shows that melatonin chewable tablets may contain one half to more than four times the amount of melatonin listed on the label.

The long-term effects and risks of melatonin use in children are not known. Because melatonin is a hormone, regular use over time may affect a childs hormonal development.

Is Melatonin Safe For Children

Further research is needed regarding the safety of melatonin for children.

Nearly 25% of children have difficulty sleeping, and parents increasingly turn to melatonin for help. Between 2007 and 2012, pediatric melatonin use rose seven-fold and is now the second most common natural supplement in this age group.

Despite its prevalence, there are reasons for parents to be cautious about using melatonin. It appears that children may be particularly vulnerable to the possible effects of this supplement on reproductive hormones. Melatonin has been associated with puberty delays, irregular menstruation, and overproduction of the hormone prolactin. It is important to note, however, that research on this topic is conflicting, and experts agree that the topic is understudied.

Parents should also be aware that melatonin may . Children taking other medications or who have illnesses affecting these systems should consult their doctor before starting melatonin.

Melatonin should only be used for children under the guidance of a doctor. Most pediatric sleep disorders can be managed with behavioral changes, such as proper sleep hygiene and cognitive therapy. Melatonin should not be used before trying other measures.

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How To Increase Melatonin Levels Naturally

You can increase your melatonin levels without supplementing.

A few hours before bedtime, dim all lights at home and avoid watching TV and using your computer or smartphone.

Too much artificial light can reduce the production of melatonin in your brain, making it harder for you to fall asleep .

You can also strengthen your sleep-wake cycle by exposing yourself to plenty of natural light during the day, especially in the morning (

Is Melatonin Approved By The Fda

10 Things You Didnt Know About The Sleep Hormone: Melatonin  Nokia ...

Melatonin is not approved by the FDA for any use. It falls under the FDAs Dietary Health and Education Act as a dietary supplement. Dietary supplements may include vitamins, minerals, amino acids, and herbs or botanicals, plus other substances used to supplement the diet. As with other dietary supplements, melatonin isn’t approved by the Food and Drug Administration for safety or effectiveness.

Manufacturers must notify FDA about new ingredients prior to marketing. After the supplement is on the market, the FDA will monitor adverse event/s that are reported to them by the manufacturer, consumers or health care professionals. If a manufacturer makes an unproven health claim or if the supplement is found to be unsafe the FDA can remove the OTC from the market.

Avoid buying dietary supplements from the Internet and from online pharmacies whose authenticity you cannot verify. It is important to remember that an OTC label that says natural supplement does not always mean its safe for consumption. Formulations that are United States Pharmacopeial Convention Verified can be considered most reliable in this regard the label USP is found on the outside of the bottle. For example, all Nature Made products are verified by the USP. The safest way to purchase drugs online is through pharmacies accredited by the Verification of Internet Pharmacy Practice Sites programs.

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Adolescence And Young Adults

Melatonin use is relatively common in adolescents and young adults. Research shows that the sales of melatonin in the United States have increased by 150% over the past several years. This increase was likely related to the increased use among children and adolescents.

Talk with your childs healthcare provider before starting melatonin. Using melatonin may increase the risk of accidental or intentional overdose in adolescents.

Can Promote Eye Health

Melatonin is high in antioxidants that can help prevent cell damage and keep your eyes healthy.

In fact, research suggests that melatonin could be beneficial in treating conditions like glaucoma and age-related macular degeneration .

In a study in 100 people with AMD, supplementing with 3 mg of melatonin for 624 months helped protect the retina, delay age-related damage and preserve visual clarity .

Additionally, a rat study found that melatonin decreased the severity and incidence of retinopathy an eye disease that affects the retina and can result in vision loss .

However, research is limited and additional human studies are needed to determine the effects of long-term melatonin supplements on eye health.


Melatonin is high in antioxidants and has been shown to treat eye conditions like age-related macular degeneration and retinopathy in human and animal studies.

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Melatonin has been shown to block the secretion of stomach acids. It also decreases the production of nitric oxide, a compound that relaxes your lower esophageal sphincter, allowing stomach acid to enter your esophagus .

For this reason, some research suggests that melatonin may be used to treat heartburn and GERD.

One study in 36 people showed that taking melatonin alone or with omeprazole a common GERD medication was effective at relieving heartburn and discomfort .

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Potential Side Effects Of Melatonin

Adverse reactions to melatonin tend to be relatively rare Trusted SourceNational Library of Medicine, Biotech InformationThe National Center for Biotechnology Information advances science and health by providing access to biomedical and genomic and mild Trusted SourceNational Center for Biotechnology InformationThe National Center for Biotechnology Information advances science and health by providing access to biomedical and genomic, with the most common side effects Trusted SourceNational Center for Complementary and Integrative Health NCCIH funds and conducts research to help answer important scientific and public health questions about complementary health including:

Much of the research has focused on the effects of taking melatonin for only a short period of time. Higher quality research is still needed, but the available evidence suggests that melatonin is generally safe for short-term use of up to three months.

Adverse effects tend to occur with higher doses or with supplements designed to provide extended release of melatonin. Aside from headache, dizziness, nausea, and daytime sleepiness, some studies have reported side effects like vivid dreams, nightmares, stomach cramps, irritable mood, and brief bouts of depression.

People taking melatonin do not appear to build up a tolerance to the supplement, but additional research is needed.

Is It Worth The Risks

Is melatonin safe to help children sleep?

Melatonin is a powerful hormone, and works unlike other sleeping aids. Its a sleep regulator, rather than a sleep initiator. Those who are really struggling with insomnia may feel compelled to take a high dose, thinking itll have a stronger effect. However, at the wrong dose, melatonin can actually make the sleeping cycle much worse, inducing drowsiness and preventing the body self-regulating its natural sleep cycle.

Melatonin dosage comes in a wide variety of strengths, from 0.2 mg to 20.0 mg. The most commonly useful dosage falls between 0.3 and 1.0 mg. Typically, if you can find the dosage perfect for you, you can get all the benefits of melatonin whilst still minimizing the side effects. Just because its unregulated and easy to purchase doesnt mean it can be taken without consequence. Exercising caution when taking melatonin is the best way to get maximum benefits with minimum drawbacks.

Note: The content on Sleepopolis is meant to be informative in nature, but it shouldnt taken as medical advice, and it shouldnt take the place of medical advice and supervision from a trained professional. If you feel you may be suffering from any sleep disorder or medical condition, please see your healthcare provider immediately. Please seek advice from a qualified medical professional before undertaking any new sleep, diet, or supplement regimen.

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