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Consensus # 6 Melatonin Treatment of Melatonin Deficiency

December 13, 2005

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After a literature review and discussions with physicians from all over the world who are well-versed in treating patients with endocrine abnormalities, we, the members of the Consensus Group of Experts of the International Hormone Society, think the time is ripe to consider treating Melatonin deficiency in adults.

Up to now, no international society has officially acknowledged the need and value of treating pineal gland deficiencies with melatonin. In some countries melatonin is not readily available, not even by prescription, because of government restrictions or lack of attention and in other countries melatonin can be bought easily, over the counter. Controversy exists about melatonin's efficacy. For some, it is an essential hormone with major effects, for others it is a useless placebo. In striking contrast with this controversy is the almost complete unanimity on melatonin's safety among researchers and physicians who are experienced with melatonin in animals and humans. Melatonin appears to be so safe that has not been possible so far to determine a lethal dose for melatonin. Even extremely high doses do not kill animals, nor do they cause dangerous effects.

We have carefully reviewed the literature on melatonin, and read and discussed the negative, as well as the positive reports, and observe that in the majority of studies, treatment with melatonin appears to produce significant beneficial effects. Studies on melatonin's inefficacy are rare, in particular on melatonin's sleep-inducing effects. The evidence is significant for the beneficial effects of melatonin on sleep, free-radical scavenging, glucose metabolism, bones, the cardio- and cerebrovascular systems (including the positive effects on serum lipids), several circadian rhythms (from the sleep-wake cycle to various hormone rhythms), and the benefit of limiting jet lag.

The controversy on melatonin's sleep efficacy may be due to a misunderstanding. We reviewed nearly 200 studies on the relationship between melatonin and sleep (including a little less than 100 placebo-controlled studies). In the vast majority of the studies significant beneficial effects on sleep were found. Rarely have there been reports on significant beneficial effects of melatonin on the essential sleep stages (slow wave sleep and rapid eye movement). Melatonin appears to work differently. It induces sleep, shortening the time it takes to fall asleep, with a faster onset of deep sleep (slow wave sleep) and REM sleep. Furthermore, melatonin relaxes the muscles and nerves by stimulating the parasympathic system. This facilitates sleep, improves sleep quality and enhances recovery.

The members of the consensus group of the International Hormone Society (IHS) find no scientific or medical reason to ban or excessively restrict the use of melatonin. Even though, this is the case in some countries. The relative safety of melatonin should reassure authorities to accept the use of melatonin, at least under doctor's prescription and supervision. Arguments do exist that validate the sale of melatonin over-the-counter without a doctor's prescription, in particular its usefulness, great safety and ubiquity in nature (it is found in every living being analyzed up to now for the presence of melatonin: from bacteria to plants and animals). If melatonin is authorized over-the-counter, we do recommend that small doses be mandatory. Most preparations now on the market are sold in tablets or capsules containing pharmacological doses, apparently useful to combat diseases such as cancer or acute ischemia. Tablets or capsules of 0.1 to 0.3 mg per day provide melatonin levels in the physiological range. Physiological doses and concentrations may be better adapted to treat a simple melatonin deficiency such as the one that is found in aging adults.

As melatonin may reduce cortisol activity, we recommend starting melatonin supplementation at a low dose (0.1 to 0.3 mg sublingual melatonin per day before bedtime, sometimes lower).

In the opinion of the members of the IHS's consensus group, the following arguments support melatonin treatment of deficient adults:
  • Melatonin is natural to humans and is a dominant hormone at night. Melatonin is fully adapted for our bodies.
  • Melatonin has several significantly beneficial effects on mental and physical health parameters, and against the development of age-related diseases.
  • Melatonin is relatively safe.
  • Pharmaceutical grade-melatonin can be purchased in pharmacies in many countries.
  • Melatonin is relatively inexpensive.

Therefore, we believe that melatonin treatment of patients with low urinary 6-sulfatoxy-melatonin levels or salivary nighttime melatonin, is justified.

In our experience, the best method to diagnose a melatonin deficiency is to check the urinary excretion of the 6-sulfatoxy-melatonin, the principal metabolite of melatonin, or, eventually, nocturnal saliva levels of melatonin.

In conclusion, we have found no convincing evidence against the use of melatonin in patients with low melatonin levels and with complaints of the symptoms of a melatonin deficiency (difficulties in sleep onset, tensed muscles at night, etc.). On the contrary, considerable evidence supports the beneficial effects of the use of physiological doses of melatonin in patients with melatonin deficiency in a program with regular monitoring.


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11 signatures for this petition
1 to 10

Clément Demaria
(no comment)
Tamilselvam Tiruchengode Natesan
melatonin role in the management of insomnia is speculative.More evidence should accumulate before its wide usage in clinical practice. Emprical therapy of insomnia with melatonin in elderly may be justified as pineal calcification may interfere with the secretion of melatonin. Intense research should focus over therapeutic efficacy of melatonin. TNTamilselvam
Alenka Radelj
(no comment)
Cecilia Wheeler
United Kingdom
(no comment)
Erika Gray
United States
(no comment)
Brian Gray
United States
(no comment)
Darwin Nicol
United States
(no comment)
Alan Turbin
United States
(no comment)
Carolyn Elmore
United States
I suffered from major anxiety for years after a minor surgery destroyed my female hormones in my ovaries. Bio Identical has saved my life and made me feel normal and happy again.
Karisha Kira
United Kingdom
I couldn't obtain melatonin in the UK as it is only available on a named patient prescription and because of this a GP is reluctant to prescribe it. The UK NHS wouldn't pay for me to go to a sleep clinic to treat my Delayed Sleep Phase Syndrome where I would probably have been prescribed melatonin. I had to import melatonin from the US (3 months supply is legal).



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