QUESTIONS AND
ANSWERS ABOUT MELATONIN
Note that the information on these pages do
not substitute for medical consultation. SLTBR is unable to answer clinical
questions, and recommends that you contact your family physician or the nearest
university medical center for the name of a mood disorders or sleep disorders
specialist.
Copyright SLTBR,
1994; revised December, 1993.
What
is melatonin?
How does melatonin work?
How much melatonin does the body produce?
What is the appropriate dose range for melatonin pills or capsules?
Can melatonin reduce let lag?
Can melatonin help people fall asleep faster and sleep more soundly?
Can melatonin help shift workers?
Can melatonin extend life?
Can melatonin boost the immune system?
Can melatonin cure cancer?
Can melatonin prevent heart disease?
Can melatonin counter infertility? Or is it contraceptive?
How safe is melatonin?
What are melatonin's side effects?
Where is melatonin sold?
What is melatonin?
Melatonin is a hormone secreted by the pineal gland in the brain.
Melatonin has a rapid, mild sleepiness-inducing effect. Because of this trait, properly timed melatonin supplements may help people adapt to changes in sleep-wake schedules, as may occur after jet travel across many time zones or in shift work. The effectiveness of melatonin for relieving insomnia is uncertain. Many concerns remain about melatonin's safety, especially for long-term use.
Don't count on melatonin to make you live longer, improve your sex life, cure cancer, or lower your cholesterol. There is little scientific basis for sensational claims for melatonin's health benefits reported recently in the popular press. These claims are based on anecdotal reports ("I tried it and it worked"), animal research - some of it flawed - and pure speculation.
This fact sheet, prepared by the leading organization of scientists working in the field of light treatment and biological rhythms, aims to set the record straight. The answers to the most frequently asked questions about melatonin come from controlled studies of more than 500 people in the past decade. The information contained here should not be used as a substitute for your physician's advice.
The secretion of melatonin follows a daily rhythm governed by the body's master clock. This clock is located in the brain and is synchronized by regular exposure to the 24-hour cycle of darkness and light. Melatonin secretion may serve as a biological time cue.
Although its natural secretion in the body peaks at night, melatonin does not control sleep. If it did, night workers would not be able to sleep in the daytime when melatonin levels are low. Although most people sleep longer and more deeply at night than in the day, melatonin most likely is only one of many factors accounting for the superiority of nighttime sleep.
How much
melatonin does the body produce?
Healthy young and middle-aged adults usually secrete about 5 to 25 micrograms of melatonin each night - at least 80 times less than is in the commonly sold 2 milligram (mg.) tablet or capsule. The amount of melatonin the body secretes tends to decline with age, a possible link with an age-related rise in difficulty sleeping.
What is the
appropriate dose range for melatonin pills or capsules?
Major questions in the research community are whether and how much melatonin is effective for the various applications described below. Recent studies mainly have used doses from 1/2 to 5 mg. Debate still centers around the essential action of the hormone - shifting the biological clock, promoting sleep, or both. Some studies have found clock-shifting results at the very lowest doses (1/2 mg.). Studies emphasizing sleep-promoting action have tended to use somewhat higher doses (2 to 5 mg.), although it is not certain that these are necessary to achieve the desired effect. Although these questions are not yet resolved, a basic clinical principle is to use the lowest dose effective for the individual and to work upward, if necessary, with a physician's guidance. The popular impression that "more works better' has not been borne out in many studies of melatonin, and larger doses probably carry a higher risk of undesirable side effects.
If flying eastward, you need to go to sleep earlier and get up earlier. If flying westward, you need to stay up later and sleep later. For the first few days after crossing multiple time zones, you are likely to be both sleepy during the day and restless at night. Taking melatonin at the right time may help jet travelers adapt faster. Timing is critical. If you take melatonin at the wrong time, your body clock may travel in the wrong direction. You might leave New York en route to Paris, for instance, but send your body clock to Honolulu.
While timing, dosages, and length of use are still being worked out, reducing jet lag is the best-tested application for melatonin, and it may be among the safest, as low dosages are taken for only a few days. The plan below has been used in several studies without causing serious side effects. It assumes that the goal is to sleep during normal nighttime hours at the travel destination.
When traveling east:
When traveling west:
Cautionary note: melatonin labeled as short-acting or known by personal experience to be short-acting should be used, and slow-release formulas avoided. Otherwise, there is a risk of daytime sleepiness. If the stay is less than four days, followed by further travel in a westward direction, melatonin is taken at bedtime the night before departure.
Can melatonin
help people fall asleep faster and sleep more soundly?
Melatonin induces sleepiness and lowers body temperature slightly, perhaps a further aid to sleep since temperature normally falls around the time sleep begins.
Several small studies of individuals suggest that some people with trouble falling asleep and/or staying asleep may benefit from taking melatonin at bedtime. However, there have been no large-scale controlled studies as yet. Responses vary considerably between individuals. Again, one should start with the lowest possible dose, and monitor responses and increase doses, if necessary, under a physician's supervision.
People who have trouble falling asleep at a conventional bedtime - often staying awake until 3 a.m. or later - but then sleep well may have a disorder of sleep timing called the delayed sleep phase syndrome. Taking melatonin two hours before their current bedtime may help them fall asleep earlier. They would gradually move back the hour they take melatonin until they reach their desired bedtime.
Other people have the opposite problem. They cannot resist falling asleep earlier than a conventional bedtime: 9:00 p.m., for example. They then may awaken fully alert around 3 a.m. and be unable to fall back to sleep. Some people with this problem, called the advanced sleep phase syndrome, benefit from taking melatonin if they awaken between 2 and 5 a.m.
Persons who are totally blind (lack all light perception) may notice cyclic trouble staying alert during the day and sleeping at night. Because synchrony of daily rhythms ordinarily requires daylight exposure, their melatonin secretion pattern may not be anchored to the normal 11 p.m. to 7 a.m. rest period. In experimental studies, tests of blood, saliva and urine have been used successfully to track the melatonin rhythm, determining when it is in synchrony with the desired bedtime. With this information, blind persons may be advised to take melatonin at bedtime from then on to keep their body rhythms in line. One impressive study of a series of cases of totally blind children with irregular sleep patterns, including daytime sleep, found major improvement when they were given melatonin at bedtime.
People who live in at a northern latitude and/or spend most of their time indoors with little daylight exposure also may suffer from a disturbed sleep/wake rhythm. Elderly persons who live in nursing homes or other institutions may be most susceptible to this problem. Taking melatonin at an appropriate bedtime may help provide stability, but concerns about possible interactions with other medication, especially in the elderly, demand caution. As yet, there have been no studies testing the effect of melatonin in demented elderly persons.
For healthy young adults with normal sleep, there are probably no benefits from taking melatonin, but there may be dangers in long term use.
Insomnia is a symptom of many disorders, including neurological and other medical disorders and psychiatric problems, and requires evaluation by a physician. Melatonin may not be an appropriate treatment.
Can melatonin
help shift workers?
Possibly, but most researchers feel it is too early to say.
The timing would depend on whether you rotate forward or backward around the clock, the number of hours you shift, and the type of work you do. Melatonin may lower vigilance for several hours after it is taken both on the job and when driving.
No studies of humans support this notion. In one group of animal studies, the pineal glands of young mice were transplanted into old mice, and vice versa. The old mice allegedly lived longer. The young mice allegedly died sooner. Some strains of mice used in these studies, however, have a genetic defect that keeps them from producing melatonin. The alleged benefits therefore could not have come from melatonin.
Can melatonin
boost the immune system?
While some positive evidence comes from animal studies, more work must be done to confirm and extend these findings. It is a big leap from mice to humans.
Some positive evidence comes from animal studies. More work must be done to confirm and extend these findings in both animals and humans.
Can
melatonin prevent heart disease?
No evidence supports this notion.
Can
melatonin counter infertility? Or is it contraceptive?
In animals, melatonin both stimulates and inhibits reproduction. In humans, most studies suggest but do not prove that it inhibits reproduction. In men, high doses reportedly lower both sperm motility and sex drive.
Current research suggests it probably is safe to use melatonin if you are:
Melatonin's long-term safety has not been established. There are growing concerns about the possibility of damage to the retina of the eye associated with melatonin use.
You should not use melatonin unless under a
physician's supervision if:
Because of concerns about transmission of viruses through animal products, melatonin derived from cow pineal glands should not be taken. Melatonin has been banned from over-the-counter sale in Great Britain, Canada, and many European countries. Most melatonin sold in the U.S. is synthetic, although some health food store clerks may confuse customers by insisting the products are "all natural."
What are
melatonin's side effects?
Acute: Minor. About eight out of 100 people taking 5 mg. melatonin or less per day to prevent jet lag feel sleepy in the daytime. Fewer than two out of 100 on this dose suffer a headache, feelings of fuzziness or giddiness, or nausea. In research studies using doses up to 300 mg. daily, the side effects occurring most frequently were diarrhea, abdominal pain and headaches. Recent studies indicate that sleeping even in a dimly lit bedroom after taking melatonin may result in unpleasant, fragmented sleep. Lights should be off, and shades drawn.
Long-term: Unknown. Caution is appropriate because effects of hormones may not become apparent for years.
Melatonin is sold as a dietary supplement, not as a drug, often in health food and other grocery stores and some drug stores. Because it is not labeled as a drug, Food and Drug Administration (FDA) regulations that apply to medications sold in the United States do not apply to melatonin. The FDA does not require manufacturers of melatonin to demonstrate that their product is safe and effective nor to monitor its safety and efficacy, as is the case for drugs.
Manufacturers are not required to list all ingredients or the exact dosage on melatonin package labels. Tests of randomly purchased samples of melatonin showed considerable variation between the amount of melatonin listed on the label and that in the actual dose. Some batches contained no melatonin at all. Some had impurities or additives such as conventional sleeping pills.
Because of concerns about transmission of viruses through animal products, melatonin derived from cow pineal glands should not be taken. Melatonin has been banned from over-the-counter sale in Great Britain, Canada, and many European countries. Most melatonin sold in the U.S. is synthetic, although some health food store clerks may confuse customers by insisting the products are "all natural."
Note that the information on these pages do
not substitute for medical consultation. SLTBR is unable to answer clinical
questions, and recommends that you contact your family physician or the nearest
university medical center for the name of a mood disorders or sleep disorders
specialist.