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REMfresh FAQ - About REMfresh

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To receive patient samples, please call 1-617-470-8412, email Samples@REMfresh.com or visit REMfreshSamples.com

REFERENCES

  1. Colten H and Altevogt B. Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem. Washington, DC: Institute of Medicine, 2006.
  2. Ford D, Kamerow D, et al. Epidemiologic Study of Sleep Disturbances and Psychiatric Disorders. An opportunity for prevention? JAMA. 1989;262 (11):1989;262:1479-1484.
  3. Zhdanova IV, Wurtman RJ, Balcioglu A, Kartashov AI, Lynch HJ. Endogenous Melatonin Levels and the Fate

of Exogenous Melatonin: Age Effects. The Journals of Gerontology Series A: Biological Sciences and Medical Sciences.

1998; 53A.4.

  1. Ko DT, Herbert PR, Coffey CS, et al. Beta-blocker therapy and symptoms of depression, fatigue, and sexual dysfunction.

JAMA. 2002 Jul 17;288(3):351-7.

  1. Scheer FA, Morris CJ, Garcia JI, et al. Repeated melatonin supplementation improves sleep in hypertensive patients treated with beta-blockers: a randomized controlled trial. Sleep. 2012 Oct 1;35(10):1395-402.
  2. Nathan PJ, Maguire KP, Burrows GD, Norman TR. The effect of atenolol, a beta1-adrenergic antagonist, on nocturnal plasma melatonin secretion: Evidence for a dose-response relationship in humans. J Pineal Res. 1997;23:131-5
  3. Khanijow V et al. Sleep Dysfunction and Gastrointestinal Diseases. Gastroenterology & Hepatology. 2015 11.12 (2015): 817–825.
  4. Watson NF, Badr MS, Belenky G, et al. Joint Consensus Statement of the American Academy of Sleep Medicine and Sleep

Research Society on the Recommended Amount of Sleep for the Healthy Adult, Methodology and Discussion. J Clin

Sleep Med. 2015:11(6); 591-592.

  1. Kripke D, Garfinkel L, Wingard D, et al. Mortality Associated with Sleep Duration and Insomnia. Gen Psychiatry. 2002; 59:131-136.
  2. McIntyre I, Norman T, et al. Melatonin Rhythm in Human Plasma and Saliva. J Pineal Res. 1987; 4.2:177-83.
  3. Sack RL, Lewy AJ, Erb DL, Vollmer WM, Singer CM. Human Melatonin Production Decreases With Age. J Pineal

Res;1986 3.4: 379-88.

  1. Brodner DC, Shah SM. REM Absorption Kinetics Trial: A Randomized, Crossover, Pharmacokinetics Evaluation of a Novel Continuous Release and Absorption Melatonin Formulation versus a Same Strength Immediate-Release Formulation in Healthy Adults (Abstract 0396). Poster presented at: SLEEP 2017; June 3-7, 2017; Boston, MA.
  2. Hahm H, Kujawa J, and Augsburger L. Comparison of Melatonin Products Against USP’s Nutritional Supplements

Standards and Other Criteria. Journal of the American Pharmaceutical Association. 1996; 39.1: 27-31.

  1. Otmani S, Demazières A, Staner C, et al. Effects of Prolonged-release Melatonin, Zolpidem, and Their Combination on Psychomotor Functions, Memory Recall, and Driving Skills in Healthy Middle Aged and Elderly Volunteers. Human Psychopharmacology: Clinical and Experimental. 2008; 23.8: 693-705.
  2. Gray S, Anderson M, Dublin S, et al. Cumulative Use of Strong Anticholinergics and Incident Dementia. JAMA Internal

Medicine. 2015 175.3 : 401.

  1. Shah SM, Brodner DC. A Continuous Release Ion-Powered Pump® Melatonin Delivery System That Overcomes

Challenges of Release and Absorption in the Intestines (Abstract 0385). Poster presented at: SLEEP 2017; June 3-7,

2017; Boston, MA.

  1. European Medicines Agency. Assessment Report for CIRCADIN. 2007.

 

REMfresh®  is different because it delivers the body’s own natural sleep ingredient, melatonin. Melatonin has been shown not to cause memory problems, morning dysfunction, drowsiness, or unusual night occurrences such as sleepwalking.14

REMfresh®  is non-habit forming. In a head-to-head trial vs. zolpidem (Ambien), prolonged release melatonin outperformed its comparator in post-dosage memory and vigilance.14 Additionally, in long-term health trials, diphenhydramine, an antihistamine found in many OTC drugs, has been linked to dementia.

REMfresh’s Sleep Hygiene Cycle™ was developed to help you establish healthy sleep habits and improve your sleep quality and duration. By following the 7 simple stepsthroughout the day and leading up to your bedtime, you may be able to fall asleep faster and stay asleep longer.

UltraMel is a high-quality, 99% ultrapure melatonin sourced from Western Europe. As the key ingredient in REMfresh, UltraMel melatonin mimics your body’s natural production of this sleep hormone due to its Advanced Ion-Powered Pump® technology delivery system. This technology continuously releases and absorbs melatonin throughout the intestinal tract and enhances absorption to provide up to 7 hours of sleep support. This helps you not only to fall asleep, but it can help you stay asleep, wake up refreshed, and experience better quality sleep overall.

REMfresh is a dietary supplement. REMfresh is regulated under the federal Dietary Supplement Health and Education Act, which does not require pre-approval. Melatonin has been in common and safe use for over two decades. REMfresh must submit all label claims to the FDA to keep on file but not for approval. The U.S. Food and Drug Administration (FDA) at all times has authority to investigate and monitor such products for safety and compliance.

Since REMfresh is not a drug, it should not cause any drug hangover.

REMfresh® is manufactured with patented Advanced Ion-Powered Pump® technology to continuously deliver and absorb melatonin throughout the intestinal tract, supporting up to 7 hours of sleep. Research has shown that the melatonin in conventional sleep aids typically is not absorbed beyond the stomach, resulting in a limited time effect. Most over-the-counter melatonin supplements, designed to immediately release melatonin, can help promote sleep onset but do little to help keep you asleep throughout the night. REMfresh was developed not only to help you fall asleep, but to help you stay asleep by mimicking your body’s natural production of melatonin so you can get a full night’s rest.

UltraMel® melatonin is the key active ingredient in REMfresh. UltraMel is a 99% ultra-pure, high-quality, pharmaceutical-grade melatonin. It is sourced from Western Europe, where melatonin is held to strict purity standards. With some other over-the-counter melatonin sleep aids, consumers can’t be sure of their label claims, purity levels or where the product’s ingredients have been sourced.

REMfresh is formulated without added gluten, dairy, fish or nuts.

REMfresh®  is made in the United States, with UltraMel melatonin imported from Europe, under strict current Good Manufacturing Practices (cGMP). Our manufacturing facilities are thoroughly inspected by the U.S. Food and Drug Administration (FDA). Unlike many other melatonin products, the innovators of REMfresh import their own brand of premium melatonin (UltraMel™) from Europe. The source of many other melatonin products is often undisclosed or imported from China or India.

The number of hours of sleep needed to feel refreshed can vary from person to person. It’s important to keep in mind that the quality of sleep can be just as important as the quantity. However an Institute of Medicine report indicated that 7 hours was the ideal amount of sleep for most people. (Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem http://www.nap.edu/catalog/11617.html)

In clinical trials, melatonin supplements have not been shown to be habit-forming.

(European Medicines Agency. Assessment Report for Circadin;2007. www.ema.europa.eu/docs/en_GB/document_library/…/WC500026808.pdf. Accessed July 11, 2019)

REMfresh is different from non-melatonin sleep products because it delivers the body’s own natural sleep ingredient, melatonin. Melatonin has not been shown to cause memory problems, morning dysfunction, drowsiness or unusual night occurrences such as sleepwalking. REMfresh® is non-habit forming and does not contain narcotics, hypnotics, barbiturates, sedatives, antihistamines, alcohol or other harsh additive chemicals.

No other melatonin product has been shown to have a 7-hour release and absorption profile (REF)REMfresh’s patented Ion-Powered Pump™ delivery technology helps support deep and refreshing sleep throughout the night.†