Melatonin: A Supplement for the Future? …. or Tonight?

Sleep like a baby.

Improve your mood.

Have more energy.

See vivid dreams.

Prevent jet lag.

And possibly live longer.

What on earth can do all this?

“I’ve heard of it,” said a friend of mine when I told her that I was writing a book on melatonin. “That’s skin pigment, isn’t it?”

She was thinking of melanin, the dark color in skin and hair. Since that conversation I’ve encountered many people who confuse the two words. Melatonin is a natural hormone made by the pineal gland, which is located in the brain (see figure). All words in italics are defined in the glossary.

Melatonin helps to set and control the internal clock that governs the natural rhythms of the body. Each night the pineal gland produces melatonin which helps us fall asleep. Research about this hormone has been going on since it was discovered in 1958. But it is only in the last few years that much attention has been paid to melatonin. Close to a thousand articles a year about melatonin are now published worldwide. One reason for this growing interest is that we are realizing that deep sleep is not the only byproduct of melatonin. We are learning that it has a significant influence on our hormonal, immune, and nervous systems. Research is showing melatonin’s role as a powerful antioxidant, its anti-aging benefits, and its immune-enhancing properties. It is an effective tool to prevent or cure jet lag, an ideal supplement to reset the biological clock in shift workers, and a great medicine for those who have insomnia. Melatonin also may have a future role to play in the treatment of cancer and heart disease, in lowering cholesterol levels, in influencing reproduction, and more. A delightful bonus is that melatonin can promote vivid dreams.

With all these potential influences on our hormonal and immune systems, no wonder melatonin has been clouded by controversy.

A Controversy That’s Bound to Grow

Melatonin supplements became available in health food stores in 1993. Heavy media attention, including CBS, CNN, and major newspaper coverage, was focused on melatonin when a study by MIT researchers, published in March of 1994, showed that it was an effective sleep inducer. Melatonin sales skyrocketed. However, the chief researcher who had directed the study, Dr. Richard Wurtman, sent a letter to the press and appeared on CNN to caution consumers, “I hope that melatonin will become an approved drug quickly. Meanwhile no one should buy it and self-medicate.” He argued that there are no agreed-upon dosages, no controls over its purity, and no formal data demonstrating that melatonin is safe. Melatonin sales slumped. The media coverage slowed.

Shortly after this warning, the National Nutritional Foods Association (NNFA), on April 11, 1994, issued an Action Alert to its members: “The leading suppliers and distributors of melatonin products in our industry will be discontinuing distribution of melatonin to health food stores. NNFA agrees with them that melatonin may be inappropriate as a product to be sold in health food stores and urges retailers to seriously consider the propriety of its continued sale.” Nervous health food store managers took melatonin off the shelves (Whole Foods, June 1994). It became more difficult for consumers to purchase melatonin. Many relied on mail order distributors for their supply.

The Wall Street Journal, in an article published in August 31, 1994, and titled Drug Companies and Health Food Stores Fight to Peddle Melatonin to Insomniacs, pointed out, “Dr. Wurtman’s letter didn’t mention his financial interest in melatonin. Last year he applied for a patent with MIT on the use of melatonin to treat sleep disorders. In March a small Lexington, Mass., company called Interneuron Pharmaceuticals Inc., obtained rights to the patent application. Dr. Wurtman co-founded Interneuron in 1988 and owns nearly one million shares, currently worth about six million dollars. Today, Interneuron is aggressively pursuing a plan to market melatonin as a prescription sleeping pill. The company still faces four or five years of clinical trials, but it thinks it has a long shot at a blockbuster drug.” Health food stores would be Interneuron’s major competition.

Melatonin sales stayed relatively slow until April, 1995, when this book, the first in the country on this topic, was published. A segment on Dateline: NBC in July, followed by my interview on the national television show A Current Affair, encouraged tens of thousands of people to buy melatonin. The melatonin phenomenon had started. Then it really exploded.
The August 7th issue of Newsweek was mostly responsible for accelerating the melatonin mania. The enthusiastic article by Geoffrey Cowley and Jamie Reno exposed millions of Americans to an otherwise little-known supplement. Health food stores copied the article and handed it out to their customers.

Shortly thereafter, on August 14th, a feature article on melatonin by Sandra Jacobs appeared in the Miami Herald, and was syndicated nationwide, appearing in dozens of major newspapers. Women’s/science/health magazines decided to ride the wave and published their own articles. Producers of radio and television shows rushed frantically to find melatonin experts and critics to answer questions and concerns voiced by new melatonin users. Countless people who had hardly noticed the existence of their local health food store crossed its threshold for the first time curiously asking the manager, “Is it all true? Is melatonin really the wonder hormone?”

But even before the melatonin mania had started, major health newsletters from universities had already formed their opinions.

The Johns Hopkins Health After 50 newsletter had an article in its February, 1995, issue, titled Melatonin: Sleep Aid of the Future? Their conclusion was, “The research to date on melatonin is encouraging, but it is still too early to consider taking the hormone for sleep disturbances…However, there is no doubt that melatonin plays a role in controlling the sleep/wake cycle, and it is even possible that melatonin will become a useful agent for sleep therapy in the future.”

The University of California at Berkeley Wellness Letter, in its April, 1995, issue, informed, “So far, at least, there have been no reports of melatonin causing any serious side effects.” But the article continued in a tone surprisingly biased. The authors mentioned their concern that supplements sold in health food stores are unregulated and potential contamination can occur. This is true, yet even medicines approved by the FDA have in some cases been found to be contaminated, or have serious health risks. The food we eat can be contaminated. The Agriculture Department estimates 5 million cases of illness and more than 4,000 deaths may be associated with meat and poultry products each year (Los Angeles Times, February 1, 1995). As far as I know, neither of the above two medical establishments has discouraged the public from buying vitamins and minerals over the counter for fear of contamination. In fact, the Berkeley Wellness Letter encourages the public to take vitamins C and E, and calcium supplements. Nor have these institutions discouraged the public from eating chicken. Why raise the contamination issue expressly with melatonin and unnecessarily alarm the public? Having advanced this concern, the authors try to further scare the reader, “Human hormones are powerful substances and can produce unexpected results in long-term use, or even in single large doses.” This statement is also true of aspirin, estrogen, prescription sleeping pills, and practically every medicine. Having raised these panic-provoking objections, and with no solid clinical or scientific reasoning to back up their position, the authors conclude, “Don’t be a guinea pig. At present we do not recommend that you take it.”

I felt unsettled. I subscribe to this newsletter and have generally found the articles to not only be of high quality, but to present a moderate and objective viewpoint when dealing with complex nutritional issues. If I hadn’t researched the scientific studies and treated patients with melatonin, I would not have challenged their conclusion.

In the summer and fall of 1995, more books about melatonin followed mine. At least two of these books hyped that melatonin supplements would reverse the aging process and lead to a better sex life.

You will be exposed to various opinions from researchers, medical institutions, physicians, authors, and organizations regarding melatonin’s effectiveness, safety, and potential for treatment of various conditions. As you formulate your decision on whose opinion to follow, please consider the following factors:

  • Is their opinion backed up by solid research? Do they list references?

  • Are they making definitive claims for melatonin’s benefits for humans based purely on laboratory and rodent studies?

  • Have they done any clinical surveys or treated patients before formulating their conclusions?

    Do not assume that an opinion from a major medical center—or me, or any other physician, researcher, or organization—is gospel. For instance, the Johns Hopkins and Berkeley Wellness Newsletter articles didn’t mention a word about the effect of melatonin on dreams, nor of the studies that found life span extension in rodents when given melatonin. This makes me wonder how much clinical experience the authors really had with melatonin and how much time they spent reviewing research articles. Having worked and studied in renowned hospitals, I know from first-hand experience that some of the physicians who write opinions on particular issues don’t necessarily have the needed time to fully read hundreds of articles before formulating their conclusions. They have hospital rounds to perform, lectures to present, meetings to preside over, other types of research to conduct, and recommendations to make on various other medicines and medical illnesses. Furthermore, academics are often insulated from the practical side of day-to-day office medicine. Large institutions are also very cautious and conservative about making new recommendations. Being overcautious by not recommending the use of a safe sleep supplement can be a disservice to the public when the alternative sleep medicines themselves are known to have serious, and potentially fatal, side effects. Patients taking pharmaceutical sleep aids have been known to experience psychosis and loss of memory. Seizures have occurred upon withdrawal.

    Throughout this book I will discuss the benefits of melatonin, its uncertainties, and its shortcomings. I will try to present an objective viewpoint based on scientific research, my clinical experience, and the results of my surveys.

    Is Melatonin Effective?

    I have found that 80% of all melatonin users like its sleep-promoting effects and would take it again if needed. About 10% did not feel a significant effect or felt it was too weak for them as a sleep aid, and the rest have not had a good experience with melatonin and did not wish to continue with it.

    Is Melatonin Safe?

    Whenever researchers want to test the dangers of a substance they give it to laboratory animals such as mice. They give progressively higher and higher doses of the substance until a lethal dose (LD) is reached where 50% of the test animals die. This level is called the LD 50. Back in 1967, at the National Heart Institute in Bethesda, Maryland, Barchas and his colleagues gave mice 800 milligrams (mg) per kilogram (kg) of body weight of melatonin. The mice exhibited no significant ill effects. The researchers needed to give more to find the LD 50, but they could not concentrate the melatonin any further in the amount of liquid that the mice had to drink. The 800 mg/kg is equivalent to giving an average-sized human over 50,000 mg. No other effective sleep inducer is this safe. As we’ll discuss later, most people do well with a nightly dose of 3 mg or less.

    When human subjects were given as much as 6000 mg nightly for 1 month, some of them complained of abdominal discomfort (Waldhauser, 1990). These high doses did lead to sleepiness the next day, but only for a few hours. No serious side effects were reported. In a longer-term study using high doses, ovarian function was inhibited (similar to the effect of birth control pills) when women took 300 mg nightly for 4 months (Voordouw, 1992). No other side effects were noted. The researchers speculate that high doses of melatonin could be used as an effective oral contraceptive. In some rodent studies, long-term supplementation with melatonin at high doses has led to reduction of sex hormones such as testosterone and shrinking of the size of gonads.

    When 6 healthy men were given 2 mg of melatonin each evening for 2 months, no changes in testosterone or other hormone levels were found (Terzolo, 1990).


    Twenty young, healthy volunteers were kept in a sleep laboratory for several consecutive nights and were monitored and subjected to a battery of tests (Waldhauser, 1990). After a few nights of this routine, half of the subjects were given a placebo and the other half were given 80 mg of melatonin. Those who received melatonin spent less time in bed falling asleep and had fewer awakenings during the night. There was little or no hangover effect the next morning. In fact, the volunteers seemed to perform better in different mental tests and felt more balanced and active. They had a sensation of well-being and emotional stability. This pleasant feeling lasted several hours.

    Since melatonin is produced naturally, the body has evolved mechanisms to remove excessive amounts. It is metabolized by the liver and possibly other organs. No reports of any serious side effects have yet been reported in the medical literature. Only rare individuals I have treated have reported any significant complaints. Almost all the side effects reported have been minor and have quickly disappeared upon discontinuation. I do want to emphasize that melatonin is a new product on the market. It will take many more years before we fully understand all potential positive and/or negative effects.

    No substance on this planet can be guaranteed to be 100% safe. Our drinking water can be contaminated. Pure water can even be fatal if a person consumes enormous amounts at one sitting. No activity we engage in is fully safe either. We take a risk every time we go skiing, get in the car to go to the movie theater, or even walk down a flight of stairs.
    The National Nutritional Foods Association, by reviewing my book in its August, 1995, newsletter mailed to thousands of health food stores, appeared to soften, or reconsider, its position against the sale of melatonin: “Many NNFA members continue to distribute or sell melatonin, or have begun to do so since the April 11, 1994, alert was sent. That being the case, it would seem advantageous to them and to the consumer to learn as much as possible about this substance. A good way to accomplish this is by reading Dr. Ray Sahelian’s book.”

    On the other hand, in the September, 1995, issue of Modern Medicine, a publication mailed to over 120,000 physicians nationwide, Dr. Wurtman reaffirmed his position, “I am actively discouraging people from taking melatonin until an adequate preparation is available, which could be very soon.” On September 12, 1995, Interneuron Pharmaceuticals announced that it had been issued a use patent from the US Patent and Trademark office to sell a low dose (0.3 mg), non-prescription melatonin formulation.

    The Johns Hopkins Medical Letter, in its January, 1996 issue, affirmed, “Taking melatonin for insomnia is ill-advised because little is known about the hormone’s overall effect.”

    My opinion differs from those who object to the current use of melatonin. Based on the available clinical and scientific data thus far, I believe there is enough evidence to support the occasional use of melatonin. It is a good alternative to prescription sleeping pills.

    My opinion also differs from those who boldly assert that melatonin supplements will reverse the aging process. It’s too early to make this claim. Perhaps after a few more years of research I may feel more comfortable in recommending melatonin as an anti-aging hormone. Furthermore, my clinical experience does not suggest regular use of melatonin leads to better sex, as some authors claim.

    Even though melatonin is a very safe supplement for short-term use, and promises to be safe for intermittent, longer-term use in low doses, such as 1 mg or less, it is still important that we follow appropriate cautions until more information is available.

    Read my book, DHEA: A Practical Guide, completely, especially the CAUTION section beginning on page 77, before initiating use.

    After reading the following chapters, you, in consultation with your physician, will need to decide whether melatonin is appropriate for your needs and whether both of you feel comfortable with its safety. If your physician is not familiar with melatonin, suggest he or she read this book.

    Melatonin became well-established as the most talked about health supplement of the decade when Newsweek repeated an article about it in its November 6 issue— and made it a cover story! USA Today had a feature article on December 20, 1995…and the media coverage of this intriguing hormone is bound to continue for a long time.

    Over the next few years many individuals who have insomnia will be helped by melatonin. A group most likely to appreciate its benefits may be seniors.

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    Ray Sahelian MD Written by Ray Sahelian MD

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