**Conflict of interest**

The authors declare no conflict of interest.

*Melatonin as a Food Supplement for Sleep Disorders DOI: http://dx.doi.org/10.5772/intechopen.91410*

*Melatonin - The Hormone of Darkness and Its Therapeutic Potential and Perspectives*

therapy of hormone-related depression in women [8].

diate procedure, and it can be consumed directly from the vial.

nowadays available covering the needs of the patients.

The authors declare no conflict of interest.

subjective feelings of jet lag" [34].

**3. Conclusions**

**Conflict of interest**

cessation of the medication.

Potential harmful effects of exogenous melatonin therapy might result in amenorrhea when used in large doses, which is likely due to suppression of gonadotropinreleasing hormone (GnRH) [56]. However, this effect is readily reversible with

OTC melatonin food supplements are supplied in various pharmaceutical dosage forms in order to accommodate all patients' needs. Usually these food supplements contain 1 mg of melatonin in order to be able to bear the EFSA claim of "Melatonin contributing to the reduction of time taken to fall asleep and to the alleviation of

Pharmaceutical dosage forms of melatonin-containing supplements include tablets and granules either for direct administration or for oral solution preparations, while recently the push and drink form is becoming popular. In this dosage form, the solid mixture containing melatonin and other ingredients is airtightly separated from the solution used for dissolution of the solid. This is achieved by using a container based on a closing storage cap-vial system, in which the closing storage cap contains the solid composition, while the vial contains the solution composition. The nutritional supplement is prepared just prior to use by an imme-

Since melatonin has a very low side effect profile and limited evidence of habituation and tolerance, it is widely used among people that suffer from sleep disorders. Various clinical trials have been conducted proving the efficacy of melatonin in treating sleep disorders regardless of the etiology. A plethora of OTC melatonincontaining food supplements, displayed in various pharmaceutical dosage forms, is

Sleep disorders, regardless of the etiology, are frequently encountered by physicians and other health-care providers. According to data from the Centers for Disease Control and Prevention (CDC), up to about 70 million Americans suffer from chronic sleep problems [57], while according to the American Psychiatric Association (APA), approximately 30% of all adults suffer from sleep disorders [58]. Considering that, supplements containing melatonin are widely used. Over the counter (OTC) melatonin-containing supplements can be easily found either online or at pharmacy stores, with beneficial claims on jet lag [59], as well as occasional sleepiness, sleep problems caused by stress, overall mood, and overall health. Melatonin is often combined with vitamins, such as B complex vitamins and micronutrients, i.e., zinc or magnesium. Clinical studies have been conducted demonstrating the synergistic effect of these combinations [60]. Magnesium supplementation improves sleep efficiency, sleep time and sleep onset latency, early morning awakening, and insomnia objective measures such as the concentration of serum renin, melatonin, and serum cortisol, in older adults [61]. Meanwhile, there is clear evidence on the antidepressant effect of vitamin B12 [62] and vitamin B6 for

**40**
