What Does This Mean To You?
Because it is not categorized as a drug, synthetic melatonin is made in factories that are not regulated by the FDA. Listed doses may not be controlled or accurate, meaning the amount of melatonin in a pill you take may not be the amount listed on the package.
Most commercial products are offered at dosages that cause melatonin levels in the blood to rise to much higher levels than are naturally produced in the body. Taking a typical dose (1 to 3 mg) may elevate your blood melatonin levels to 1 to 20 times normal.
Side effects do not have to be listed on the product's packaging.
Yet, fatigue and depression have occasionally been reported with use of melatonin.
When given to animals, melatonin can
increase blood pressure and affect fertility. Such effects in humans would be a medical risk for people with heart-related problems, hypertension and stroke, kidney disease and sleep apnea as well as for women of child-bearing age.
For melatonin to be helpful, the correct dosage, method and time of day it is taken must be appropriate to the sleep problem. Taking it at the "wrong" time of day may reset your biological clock in an undesirable direction. How much to take, when to take it, and melatonin's effectiveness, if any, for particular sleep disorders is only beginning to be understood.
While there are real concerns about the widespread use of melatonin sold as a consumer product, there have not been any reported cases of proven toxicity or overdose.
Melatonin: The Basic Facts