Why we selected this company:

Supplements for Sensitive People
Pure Encapsulations supplements are hypoallergenic. There are absolutely no hidden fillers or coatings, binders, shellacs, artificial colors, fragrance or excipients in their products that would disrupt or diminish the bioavailability of any of our ingredients. Furthermore, their products are free of wheat, yeast, gluten, corn, sugar, starch, preservatives or hydrogenated oils.

Ingredient Quality
Their ingredients are selected solely on the basis of quality and purity and are provided in their most potent and bioavailable forms. They purchase premium raw materials from Japan, Switzerland, Germany, Italy, France, and of course, the U.S. Manufacturers of ingredients must pass rigorous pharmaceutical grade analytical tests to qualify as Pure Encapsulations suppliers.

Manufacturing and Quality Control Excellence
They manufacture their supplements in their own state-of-the-art facility in Sudbury, Massachusetts.  Their dedication to cleanliness is obvious from the moment their plant is entered. A large staff is dedicated full-time to the task of ensuring that their plant is impeccable.

Each step of the manufacturing process is governed by exacting standards and exceeds the requirements for nutritional supplement manufacturing. All manufacturing takes place in humidity- and dust-controlled individual rooms. Each piece of equipment used in the manufacture of Pure Encapsulations supplements is dismantled and sterilized before each production run. This includes scales, mills, blenders, powder fillers, encapsulating machines and capsule counters.

Each Pure Encapsulations lot is submitted to an independent laboratory for final confirmation of potency and conformance with ingredient levels. They are the only supplement manufacturer that has FDA certified laboratories test every batch of finished, encapsulated products.  This is an important distinction from companies that use in-house laboratories, use skip-lot testing or test ingredients prior to encapsulation or tableting.

All of their customers have access to the test results by viewing over 200 assays available on CD, verifying their uncompromising standards.

All finished products must also pass the USP Microbial Limits Test.  Our finished products are tested by Integrated Biomolecule Corporation, Vanguard Scientific, Eurofins Scientific and Advanced Food Micro.

Why we selected this product:

MELATONIN - Sleep Disorder

Melatonin is a hormone produced in the pineal gland during the dark hours which plays a role in the internal synchronization of the circadian system. The timing of melatonin production is regulated by the endogenous clock located in the suprachiasmatic nucleus of the hypothalamus. Melatonin decreases with aging. Impaired melatonin secretion is associated with sleep disorders in old age. Circulating melatonin levels have been found to be significantly lower, and have delayed onset and peak time in elderly insomniacs as compared to age-matched controls. Subjects were evaluated for 7 consecutive days while taking either 2 mg of melatonin in sustained-release form or fast-release form, or a placebo 2 hours before bedtime. In a second part of the study, subjects took 1 mg of sustained-release melatonin 2 hours before bedtime. For sleep initiation, it was found that a 1-week treatment of the fast-release 2 mg melatonin was as effective as the 1 mg sustained-release melatonin for 2 months. Sleep maintenance was improved only after 2 months of treatment with the sustained-release melatonin. The beneficial effect on sleep of the fast-release tablets may come from the high amount of melatonin released immediately after administration, while the benefit from the sustained-release tablets may come from the release of melatonin in small doses during the night. The fact that sleep initiation was improved upon long-term treatment with sustained-release melatonin suggests stabilization of the sleep-wake cycle in melatonin-deficient elderly insomniacs. In humans, melatonin plays a role in both synchronizing the sleep-wake cycle and in promoting sleep. Exogenously administered melatonin may help certain types of insomnia that are related to disturbances in normal secretion of melatonin.
     
"Melatonin - A Possible Link Between Sleep and the Immune System," Haimov, Iris, et al, Israel Journal of Medical Sciences, 1997;33(4):246-250.

MELATONIN - Role in Health and Disease

This is an extensive review article on the role of the hormone melatonin. Melatonin's chemical name is N-acetyl-5-methoxytryptamine. Melatonin is secreted from the pineal gland. Its secretion is controlled by the prevailing light-dark environment acting through the hypothalamic suprachiasmatic nuclei. Melatonin is independent of sleep. In mammals it is light and darkness perceived by the eyes which synchronizes the circadian activity of the gland. In birds, light directly penetrating the skull influences pineal function. Pineal melatonin is inhibited by light and stimulated during darkness through a multi-synaptic neuropathway which connects the retina, through the suprachiasmatic nuclei of the hypothalamus, preganglionic neurons in the upper thoracic spinal cord and post-ganglionic sympathetic fibers from the superior cervical ganglia to the pineal gland. Sympathetic innervation that is intact is important in melatonin secretion. Melatonin levels continue to fall from adulthood to old age at which time virtually no melatonin rhythm can be observed. Melatonin is well tolerated, nontoxic and a highly diffusible substance due to its lipophilic character and extremely high doses of up to 100 and even 300 mg per day have been used. At these high doses melatonin remains in the circulation over 24 hours. Behavioral effects have been recently observed after doses as low as .1 mg. The lower doses have been shown to result in a significant fall in sleep latency. Melatonin has been observed to be a potent inhibitor of cancer growth. Circulating nocturnal melatonin have been found to be lower in women with estrogen positive/progesterone positive receptors in breast cancer. Melatonin appears to have a stimulatory effect on natural killer cells and an antagonistic effect on stress-induced immunosuppression. The secretion of luteinizing hormone was found to fall in women given exogenous melatonin together with synthetic progestogen as a contraceptive. In 42 women studied throughout a treated and controlled cycle no luteinizing hormone surges were observed at midcycle and in the treated cycles. These women received both melatonin and norethisterone. There has been an association between the diurnal and seasonal rhythmicity of melatonin production and seasonal affective disorder in various types of endogenous depression. Investigators have evaluated melatonin concentration in the blood, central nervous system and vitreous humor from 32 infants who died with Sudden Infant Death Syndrome (SIDS) and compared them to values with another group of 36 children who died from other causes. After adjusting for variables melatonin was significantly lower in the SIDS children and these differences were maintained when only infants age 3 months or less were considered. A deficient maturation of endogenous melatonin rhythm reflecting in an abnormal maturation of sympathetic nervous system may play a part in Sudden Infant Death Syndrome (SIDS). Weissbluth and Weissbluth (1994) have found a failure of the normal pineal gland development and melatonin secretion resulting in a chemical imbalance between serotonin, progesterone and catacholamines ending in SIDS as a result of neurotoxic and cardiomyotoxic effects of abnormally elevated catecholamines and intracellular calcium ions. Aside from a visible light, certain nonvisible ultraviolet wave lengths and extremely low frequency electromagnetic fields may influence melatonin rhythm. The inhibitory effect of pulse intermittent static magnetic fields on nocturnal metabolism of serotonin to melatonin in the mammalian pineal gland have been observed. The physiologic relevance of this is unknown in man. The potentially hazardous effects of electromagnetic fields on melatonin disturbances should not be ignored given the ever increasing exposure to man made magnetic fields in industry, offices and homes as well as natural electric and magnetic fields.

"Role of Melatonin in Health and Disease", Webb, Susan M. and Puig-Domingo, Manuel, Clinical Endocrinology, 1995;42:221-234.

Benefits for the body:
Supports the body's natural sleep cycle

Interesting facts:
Melatonin is a hormone produced by the pineal gland, the organ that regulates the body’s wake/sleep/wake cycle. The hormone is activated by darkness and depressed by light. As people age, their sleep quality often undergoes significant deterioration, commonly characterized by frequent and longer-lasting nighttime awakenings. In many older people, sleep disturbance is correlated with a decline in melatonin secretion. A number of published studies also show that decreased melatonin production is associated with the onset of a host of degenerative diseases.

Ingredients:

Contains - Hypo-Allergenic Plant Fiber, Vegetable Capsule

Does Not Contain -

Hidden Coatings, Excipients, Binders, Fillers, Shellacs, Artificial Colors, Fragrance, Dairy, Wheat, Yeast, Gluten, Corn, Sugar, Starch, Soy, Preservatives, Hydrogenated Oils

Dosage:
As a dietary supplement, take 1 capsule daily at bedtime.

WARNINGS:

Store sealed in a cool dry area. Keep out of reach of children. Use only if safety seal is intact.

Not to be taken by pregnant or lactating women. May have sedating effects and is for bedtime use only. This product may be contraindicated in depression, seasonal affective disorder, schizophrenia, autoimmune disease, asthma and for individuals tasking MAO inhibitors or corticosteroids.

Melatonin ...20mg (99.5% pure synthetic melatonin)

*These statements have not been evaluated by the FDA.  If in doubt consult with a licensed naturopathic physician before use.  Physicians at Genesis Health Systems can be reached at 480.284.8155 and we are happy to consult with you about this product and helping you achieve optimal health.