Examining The Safety and Effectiveness of Melatonin Production

 

“The therapeutic value of a supplement is only as good as its raw materials, which has a direct effect on how we perceive the product and its results. Melatonin is a good example.”

 

Melatonin has become one of the most popular health products over the last decade, and the global market of melatonin has increased tremendously, yet the quality of the products available within the market varies significantly in both strength and purity which influences not only the products’ effectiveness but also their safety. The problem is not only with inaccurate labels but other ingredients included alongside melatonin. Another important factor of melatonin production is the quality of the raw material – which greatly influences the therapeutic effect of the final product – and whether the melatonin is naturally sourced or synthetic. The natural form, which comes from the pineal gland of animals, may be contaminated with animal viruses or environmental toxins or mixed with unknown synthetic material. The lower grades of raw materials can also be mixed with fillers and the potency can vary capsule to capsule. The USP quality standard raw material leaves no room for guess work, it must be tested to pharmaceutical standards and must be pure and exact.

 

 

Another factor, which we have discussed before, is the issue of presenting a hormone like melatonin as candy (e.g. gummies or the chewable alternatives) because it certainly is not. Almost, all hospital overdose visits are attributable to gummies. Melatonin is a naturally produced hormone in the body, that is true, but it does not mean that the melatonin sold in health food stores is the same as the one produced in the body, their origins are not the same. Another important note that we have addressed in our previous newsletters is the variability of the dose and potency of melatonin supplements. This means that the information on the label, whether a pill or a gummy may not match the actual content of the product.

With the benevolent use of the word melatonin and the popularity of products containing it in all shape and forms, it is no surprise that the type of studies questioning its benefits arise—it is easy to state anything even slightly scientific that would undermine the benefits of a quality product when there is so much noise around.

According to a new observational study of the American Heart Association (AHA), the “review of 5 years of health records for more than 130,000 adults with insomnia who had used melatonin for at least a year found they were more likely to be diagnosed with heart failure, require hospitalization for the condition or die from any cause. The association between melatonin and increased risk of heart failure or death (…) cannot prove a cause-and-effect relationship.”[1] Why? Maybe because they failed to include what other medication could these people have been taking or if they had any comorbidity. What we know is that they excluded from the analysis those who “had previously been diagnosed with heart failure or had been prescribed other sleep medications.”[2] We also know that they intermingle facts with speculation i.e. “heart failure occurs when the heart can’t pump enough oxygen-rich blood to the body’s organs for them to function properly and is a common condition that affects 6.7 million adults in the U.S.” and “participants taking melatonin were nearly 3.5 times as likely to be hospitalized for heart failure when compared to those not taking melatonin (19.0% vs. 6.6%, respectively),”[3] according to their secondary analysis.

“The research could only track prescribed melatonin, since some over-the-counter use isn’t recorded in medical records.”[4] So if it is prescribed then the dosages should not fluctuate and what is on the prescription should be on the label. Also, if doctors know that melatonin is not recommended for chronic insomnia then why are they prescribing it for 5 years when it should be used for occasional use? Since this observational study was based on prescribed melatonin using a controlled product why wouldn’t they list the other drugs these participants were taking? They claim that melatonin may interact with prescribed medication but if this is the case, could any of these interactions used for 5 years cause an increased risk of hospitalization or death? Especially when knowing that properly prescribed prescription drugs are the third leading cause of death.

Could it be that they want to have better control over the sale of this popular over the counter health product and that they are releasing these unsubstantiated findings to cause doubt and to remove over the counter access to melatonin like they do in the UK, Australia, and the European Union, where melatonin is available only by prescription for short-term treatment of insomnia? Rather than removing the access to over the counter use would it not be better to ensure that the suppliers producing melatonin are held responsible for the products they sell, and that what is written on the label match what is in the product? Whereas gummies, the statistics mentioned could be reduced if they used child sensitive caps and parents kept them out of reach for children. Enforcement should begin with the manufactures and the parents.

It is important to mention that “the organization also noted that individuals who sleep poorly tend to have higher heart rates and blood pressure and experience more cardiovascular events. Therefore, these findings are unlikely to apply to healthy adults who use melatonin dietary supplements occasionally for sleep support.”[5] The question is why alert the public with greater risk of developing a heart attack if taking melatonin when these findings are not substantiated?

This speculative study goes against a previous one Evidence for the Benefits of Melatonin in Cardiovascular Disease from 2022 in which they concluded that “[n]early all the studies have reported positive effects of melatonin on cardiovascular physiology, and the prevention of damage to the myocardium after heart attack, IR injury, or sepsis. Melatonin can also help blood pressure and heart arrythmia.”[6]

Here is the current consensus regarding melatonin and serious health conditions: the scientific and medical communities must differentiate between “links” (associations found in observational studies) and “causes” (confirmed through controlled, peer-reviewed studies). They must be careful when alerting the public and should not overstate their findings without solid facts and robust evidence. Melatonin is a hormone, not a benign supplement. Concerns exist about its potential interference with hormonal systems, especially in children and adolescents.

Melapure Melatonin has been used in clinical studies for treating insomnia, oxidative stress, preeclampsia, cancer, fibromyalgia, hair loss in women, and several other diseases. Synthetically-sourced from the amino acid L-tryptophan, Melapure Melatonin is safer to use than the natural sourced varieties because it is free from all biological contaminants and it is vegan. The other benefit of Life Choice Melapure Melatonin is that it does not shut down your own serotonin production.

The therapeutic value of a supplement is only as good as its raw materials, which has a direct effect on how we perceive the product and its results. Melatonin is a good example. Life Choice uses Flamma’s patented USP grade melatonin, we pay $2,000 US for one kilo while the Chinese sourced melatonin is priced at $175 CAN per kilo—a huge price difference but the quality standards bring peace of mind. Many people taking higher dosage experience side effects using non-regulated melatonin e.g. vivid nightmares, clenching of the teeth, muscle spasms or anxiety—these side effects are the results of the quality sourcing of the raw material used and not from melatonin itself. The old saying “you get what you pay for” rings true with melatonin for when the science is invested into the material the results will be therapeutic. On the other hand, Life Choice will never make gummies if it is for a medicinal product because medicine must remain respected and should not be misrepresented as candy.

For children we never recommend using a high dosage of melatonin; for sleep we would recommend 4 to 7 drops (7 drops = 1 mg) of Sweet Dreams Liquid Melapure Melatonin, it is safe, effective and you never need to worry about shutting down the child’s serotonin production.

  • To help improve the length of sleep we recommend taking L-Glycine 30 minutes before taking Melapure Melatonin.
  • To help set the mood and reduce anxiety you can try Kava Kava or L-Tryptophan.
  • In case of chronic insomnia you need to understand that insomnia is a symptom, the root cause originates elsewhere. When in doubt, start with re-establishing the gut since most disease conditions originate from the gut. Approximately 90—95% of the body’s serotonin is found in the gut, where it plays a crucial role in regulating functions like mood, sleep, and appetite. The best way to rebalance the gut is with Laktokhan and Full Spectrum Digestive Enzyme.

Additional Reading:

 

References:

 

[1] American Heart Association. 2025.

[2] Ibid.

[3] Ibid.

[4] Miller, Cara Michelle. 2025.

[5] Stabile, Angelica. 2025.

[6] Tobeiha, Mohammad et al. 2022.