Melatonin: Drug or Supplement? Exploring Its Effectiveness for Insomnia - Pharmacology

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Melatonin


Currently, melatonin is classified as a dietary supplement in the United States.
Regarding its efficacy for insomnia, research suggests that melatonin can be effective in improving sleep onset and overall sleep quality for some individuals, particularly in cases of circadian rhythm disorders.
However, its effectiveness may vary from person to person, and it is advisable to consult a healthcare professional for personalized recommendations.
Thank you.

Kelly, 20~29 year old female. Ask Date: 2004/09/09

Dr. Hou Fangmin reply Pharmacology


Hello: Melatonin, also known as "poly-melatonin," is a hormone secreted by the brain's pineal gland.
It causes the aggregation of melanin granules in the pigment cells of frog skin near the cell nucleus (hence the name poly-melatonin), making the skin appear lighter (which is why some refer to it as "de-pigmenting hormone").
The production and secretion of melatonin are influenced by two factors: (1) Light and darkness: Light passes through retinal nerve cells to the hypothalamus, then through the sympathetic nervous system to the pineal gland, inhibiting melatonin secretion.
Conversely, darkness promotes melatonin secretion.
(2) Circadian rhythms: Certain cells in the hypothalamus act like a "biological clock," causing variations in melatonin secretion by the pineal gland throughout the day.
Generally, the concentration of melatonin in the blood is six times higher at night than during the day, promoting sleep and regulating circadian rhythms.
It can also help with sleep difficulties after surgery.
Regarding its effects on aging: Research has found that melatonin has antioxidant properties and can scavenge free radicals, potentially preventing or alleviating cellular damage from oxidants and free radicals, thus achieving "anti-aging" effects.
Adults experience aging due to the gradual decrease in melatonin levels.
However, there is still a lack of strong clinical evidence to confirm that melatonin treatment can indeed provide "anti-aging" benefits.
As for whether melatonin is classified as a food or a drug, if the melatonin content exceeds 0.3 mg, it is considered a drug; if it is 0.3 mg or below, it is classified as a food product.
This can be purchased at any supermarket.
If you want to check whether it has a license number, you can verify with the Department of Health's Pharmaceutical Affairs Division to see if it is classified as food or a drug.
Thank you for your question.

Reply Date: 2004/09/09

More Info


Melatonin is a hormone that is naturally produced by the pineal gland in the brain, primarily in response to darkness. It plays a crucial role in regulating the sleep-wake cycle, also known as the circadian rhythm. In recent years, melatonin has gained popularity as a supplement for managing sleep disorders, particularly insomnia. However, the classification of melatonin as a drug or a supplement can vary by country and the specific formulation of the product.

In the United States, melatonin is classified as a dietary supplement, which means it is available over the counter without a prescription. The Food and Drug Administration (FDA) does not regulate dietary supplements as strictly as prescription medications, which means that the quality, purity, and dosage of melatonin supplements can vary significantly between products. Typically, melatonin supplements contain doses ranging from 0.5 mg to 10 mg, and the appropriate dosage can depend on individual needs and responses.

Regarding its effectiveness for insomnia, research has shown that melatonin can be beneficial for certain types of sleep disorders. Studies indicate that melatonin can help reduce the time it takes to fall asleep, improve sleep quality, and increase total sleep time, particularly in individuals with delayed sleep phase disorder or those experiencing jet lag. However, the effectiveness of melatonin can vary widely among individuals, and it may not work for everyone.
For adults with primary insomnia, the evidence is mixed. Some studies suggest that melatonin can be effective in improving sleep onset and duration, while others show minimal benefits compared to placebo. It is also important to note that melatonin is generally considered safe for short-term use, but potential side effects can include dizziness, daytime drowsiness, and vivid dreams or nightmares.

In terms of long-term use, the safety profile of melatonin is still being studied. While some research suggests that melatonin may have antioxidant properties and could potentially aid in age-related sleep disturbances, more robust clinical trials are needed to establish its long-term efficacy and safety.

In summary, melatonin is classified as a dietary supplement in the United States and is widely used for managing sleep issues, particularly insomnia. While it can be effective for some individuals, its efficacy can vary, and it may not be a one-size-fits-all solution. If you are considering using melatonin for insomnia, it is advisable to consult with a healthcare professional to determine the appropriate dosage and to discuss any potential interactions with other medications or underlying health conditions. Additionally, practicing good sleep hygiene, such as maintaining a consistent sleep schedule, creating a comfortable sleep environment, and limiting exposure to screens before bedtime, can also significantly improve sleep quality.

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