Melatonin drug administration

In recent years, there has been a lot of hype in the media about melatonin and its use as an aid to treat temporary insomnia or jet lag. There has also been some controversy and debate among scientists and physicians as to whether or not melatonin actually helps people sleep. Regardless, melatonin is sold as an over-the-counter supplement in most pharmacies and nutrition and health food stores (Figure 4.1). However, since it is sold as a dietary supplement, the amount of melatonin in each pill as well as the makeup of other ingredients that these melatonin pills might contain, are not regulated by the U.S. Food and Drug Administration. 

Although melatonin is a hormone and a drug, it is not regulated by the Food and Drug Administration (FDA). That is because melatonin is naturally found in... 

Because melatonin is found in certain foods, the Food and Drug Administration considers it to be a dietary supplement instead of a drug. However, since melatonin has not been studied very extensively, it is still unknown if it causes long-term side effects. 

Valerian is an herbal sleep remedy that has been studied for its sedative-hypnotic properties in patients with insomnia. The mechanism of action of this herb is still unknown, but it may involve inhibition of the enzyme that breaks down y-aminobutyric acid (GABA). The recommended dose for insomnia ranges from 300 to 600 mg. An equivalent dose of dried herbal valerian root is 2 to 3 grams soaked in 1 cup of hot water for 20 to 25 minutes. As with melatonin, and other herbal products not regulated by the Food and Drug Administration (FDA), valerian is not regulated for quality or consistency. 

As mentioned previously, one of the major benefits of nasal drug delivery is the rapid onset of action (tmax)- Migraine treatment takes advantage of this fact. Compared to the orally taken tablet, tmax is much shorter. The neurosecretory hormone melatonin, which is used widely against jetlag, shows a very impressive time profile when administered as a nasal spray. The peak levels of melatonin after nasal administration appear to be 50 times higher than after oral administration. 

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