There are some potential dangers in taking melatonin, especially long term, which include possible heart disease, increased fracture risk in older adults, interactions with some medications and possible side effects like headache, dizziness, daytime drowsiness, confusion or irritability, and even nausea.
Melatonin though is generally safe when taken short term.
The reason why melatonin is no longer recommended is because of safety concerns regarding use of melatonin long term, as well as a lack of FDA regulation of the melatonin supplements and even recent preliminary findings that link long term use of melatonin to potential health risks.
The primary issues with melatonin are that melatonin is classified as a dietary supplement in the United States and not a drug, which means that melatonin does not undergo any of the rigorous safety and efficacy testing and approval process by the FDA before it's sold which results in inaccurate dosing and also hidden ingredients like serotonin or sometimes cannabidiol which can be harmful and or interact with other medications.
Short term use of melatonin is generally safe, but long term use can be harmful and because melatonin is a hormone, there are concerns t long term use of melatonin, especially in children and adolescents, it could interfere with puberty as well as other hormonal processes.
And a recent, preliminary and not yet peer reviewed study abstract also presented at an American Heart Association meeting suggested there's an association with long term melatonin use over a year and an increased risk of heart failure and death from any cause in adults with insomnia.
Melatonin supplements also might not work for everyone and can even make insomnia worse in some people.
But for most people melatonin supplements do help you sleep when taken 1 to 2 hours before bed.
Melatonin pills are made from synthetic melatonin that is also chemically identical to the body's own hormone melatonin and is also mixed with inactive fillers and binders lie cellulose, magnesium, stearate and maltodextrin.
Melatonin pills also often have added vitamin B6 and other ingredients for an enhanced effect.
The active ingredient in melatonin pills is melatonin (N-acetyl-5-methoxytryptamine), usually synthesized in a lab.
Fillers and binders help form the melatonin pills and these fillers for melatonin pills include Microcrystalline Cellulose, Maltodextrin, Dicalcium Phosphate, Silicon Dioxide).
The coatings and shells of melatonin pills are made from Gelatin, Titanium Dioxide) or tablets (e.g., Hypromellose, Methylcellulose).
Flow agents in melatonin pills include Stearic acid and or Magnesium Stearate and optional additives in melatonin pills are vitamin B6 which is often 10 mg for better absorption and function.
Melatonin is not considered to be a drug and is instead a supplement or dietary supplement at least in the United States.
In the United States, melatonin is considered legally to be a dietary supplement and not a drug.
And because melatonin is legally considered a dietary supplement in the United States and not a drug, melatonin in the United States is not subject to the same strict regulation and approval process by the FDA or Food and Drug Administration as over the counter medications and prescription medications are.
Although in many other countries including the United Kingdom, most of Europe and Australia, melatonin is classified and regulated as a medication or a prescription only medicine.
In the United States, melatonin supplements are not approved by the FDA for specific medical uses, safety or efficacy before they are sold.
And due to the lack of stringent oversight in the United States, studies have found that the actual melatonin content in some products can also vary widely from the amount that is listed on the label and some might even contain contaminants.
And because melatonin is treated and classified as a medication in many other countries, the use of melatonin in those other countries is more often under the supervision of a specialist or doctor.
But in the United States, melatonin is available widely over the counter, although doctors still recommended consulting them before using it, especially when using melatonin long term or when used in children.
Melatonin acts as a hormone in the body and is a pharmacological agent, and it's legal status and regulation also vary globally, which lead to different classifications as a supplement versus a drug and medicine.
Melatonin is also naturally made in the body and sometimes you might need supplemental melatonin when the body is not producing enough of it for you to sleep properly.
The body naturally produces melatonin in the pineal gland, which is a tiny brain structure that the melatonin is made in at night in response to darkness to regulate your sleep and wake cycle or circadian rhythm.
Light suppresses the production of melatonin in the pineal gland and low light and darkness trigger the release of melatonin which signals the body to prepare for rest, with levels of the melatonin peaking in the middle of the night.
The melatonin production process involves light sensing, signal to the Pineal gland, synthesis, release and circadian rhythm.
The eyes detect light and send signals to a part of the brain called the suprachiasmatic nucleus, which is your internal clock.
During the day, the light tells the suprachiasmatic nucleus to stop melatonin production, and then as darkness falls, the suprachiasmatic nucleus signals your pineal gland to start making melatonin again.
The pineal gland synthesizes the melatonin from the amino acid tryptophan.
Melatonin is then released into your bloodstream and cerebrospinal fluid and acts as a chemical messenger, which tells the body that it's time to relax and get ready to sleep.
The process creates a daily rhythm, with high melatonin at night and low levels of melatonin during the day, which helps the body maintain it's sleep and wake cycle.
Darkness is essential for triggering the production of melatonin, and longer nights like in the winter can increase the melatonin secretion.
And bright light, especially before bed can significantly inhibit the melatonin release.