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Physicians and Sleep Specialists 2017-09-29T15:25:44+00:00

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Melatonin Declines with Age

As with every hormone, research shows melatonin levels typically decline with age. Melatonin levels begin to decline around age 30. Then there is a significant  decrease in melatonin levels after age 40, which accelerates as patients approach 60.

Growing scientific data shows that melatonin supplementation can promote both improved sleep onset and maintenance in this patient population. However, the delivery of exogenous melatonin in the body has not been fully optimized for this purpose, until recently.

Melatonin Formulations

Traditional Immediate Release (IR) melatonin formulations on the market can improve sleep onset but fail to address sleep quality and maintenance due to melatonin’s short half-life. Also, timed release melatonin formulations do not faithfully replicate the body’s own melatonin release profile.

REMfresh’s patented Ion Powered Pump System™ (IPP) is scientifically designed to address these limitations by mimicking the body’s own melatonin release profile. It allows melatonin to be continuously released and absorbed throughout the intestinal tract for up to 7 hours.

REMfresh Pharmacokinetics

REMfresh contains 2mg of melatonin in a prolonged release formulation that has the following release characteristics designed for fast onset and sleep maintenance:

Quick release and absorption of melatonin within the first hour after dosing, to obtain a faster onset of action

A flat-topped (plateau) release profile—similar to the body’s own melatonin release profile— that exceeds 1000 pcg/ml plasma levels for up to 7 hours to help induce a full night of deep, restorative sleep

In slow-metabolizing patients, this release profile minimizes the build up of resistance to melatonin for sleep onset caused by the presence of metabolites associated with IR surge dosing

A reliability of response and maximum time of exposure above 1000 pcg/ml. This ensures a plasma concentration that is 10 times higher and enhances the likelihood of matching the exposure of melatonin in the brain during normal sleep

A rapid decline of melatonin level in plasma at the 7-hour time point—similar to pre-dosing endogenous levels—that allows individuals to wake up refreshed and without a “drug hangover effect”

REMfresh Applications

REMfresh can be recommended as melatonin supplementation for people experiencing occasional sleeplessness or other sleep issues.

Below you will find some clinical research supporting the sleep-inducing effects of melatonin, the effectiveness of prolonged release melatonin, and safety studies.

Melatonin Clinical Studies

Melatonin has been studied clinically for decades. Its efficacy and safety have been established by multiple studies worldwide. Below you will find links to the abstracts of key melatonin articles. (For reference and medical education purposes only).

General Overview of Melatonin

Melatonin in Humans
The New England Journal of Medicine, 1997.

Sleep-Inducing Effects of Melatonin

Sleep-Inducing Effects of Low Doses of Melatonin Ingested in the Evening
(Harvard Medical School and MIT)
Clinical Pharmacology & Therapeutics, 1995.

Effects of Exogenous Melatonin on Sleep: A Meta-Analysis
(MIT, Boston University School of Medicine, University of Glasgow, UK, and Hadassah Medical Center, Israel)
Sleep Medicine Reviews, 2005.

Meta-Analysis: Melatonin for the Treatment of Primary Sleep Disorders
(Yale University, Children’s Hospital of Michigan, and University of São Paulo Medical School)
PLOS One, 2013.

Prolonged Release Melatonin

Prolonged-Release Melatonin Improves Sleep Quality and Morning Alertness in Insomnia Patients Aged 55 Years and Older and Has No Withdrawal Effects
(The Clinique Lyon-Lumière, France; Neurim Pharmaceuticals, Israel; Tel Aviv University, Israel)
Journal of Sleep Research, 2007.

Prolonged-Release Melatonin for Insomnia – An Open-Label Long-Term Study of Efficacy, Safety, and Withdrawal
(The Clinique Lyon- Lumière, France; Shoham Geriatric Medical Center, Israel; Neurim Pharmaceuticals, Israel; Tel Aviv University, Israel)
Therapeutics and Clinical Risk Management, 2011.

Safety

Nightly Treatment of Primary Insomnia with Prolonged Release Melatonin for 6 Months: A Randomized Placebo Controlled Trial on Age and Endogenous Melatonin as Predictors of Efficacy and Safety
(University of Glasgow, UK; Tel Aviv University, Israel; and CPS Research, UK)
BMC Medicine, 2010.

How to Take REMfresh®

 

  • REMfresh is indicated for occasional sleeplessness
  • Take 1-2 caplets nightly,  30 to 60 minutes before bedtime
  • Do not exceed 5 caplets per night
  • Do not crush or chew the tablet
  • Can be taken with or without food
  • Works best when used along with your individual Sleep Hygiene Cycle™
  • REMfresh® shouldn’t be taken by children under 18 or by pregnant or nursing women

REMfresh® Frequently Asked Questions

 

Q: How many people have issues falling and staying asleep?

A: Occasional Sleeplessness is very common. One in three adults suffers from it, often in silence. Sleep issues affect women more often than men, and can occur at any age. However, adults over 40 are more likely to experience occasional sleeplessness than younger people, partially due to a reduction in production and secretion of the body’s own sleep hormone, melatonin.

Q: What is the recommended amount of sleep per night?

A: A recent study in 2014 found that 7 hours is the optimal amount of time for healthy adults to sleep. REMfresh is uniquely formulated to release the body’s key sleep ingredient, melatonin, for up to 7 hours.

Q: What is melatonin, and why is it so important?

A: Melatonin is the body’s own sleep hormone which is produced by the pineal gland in the brain. Usually, melatonin release starts in the evening when the sun goes down, and then it continues to be released throughout the night. If one were to look at a typical release pattern of melatonin throughout the night, on a graph, its shape would resemble a mesa, a flat topped hill with steep sides. This pattern can be referred to as the Mesa Wave™. As people age their bodies may no longer produce enough melatonin for an adequate Mesa Wave™required for quality sleep.

Q: At what age does melatonin production start decreasing in adults?

A: The body produces its peak adult melatonin levels in the teenage years. Then, like most hormones, melatonin levels begin to decline in production around age 30. There is a significant decrease in melatonin levels after the age of 40, which accelerates as you approach 60.

Q: What is REMfresh®?

A: REMfresh® is a unique, continuous release and absorption formulation of ultra pure melatonin, UltraMel™. REMfresh® uses a patented, scientifically advanced Ion Powered Pump (IPP)™ Technology to release and absorb premium melatonin for up to 7 hours. This may help your patients fall asleep faster, stay asleep longer and experience quality sleep (i.e deep sleep and REM sleep).

Q: What is UltraMel™ melatonin and why is it better?

A: UltraMel™ melatonin is a high quality, 99% ultra pure melatonin sourced from Western Europe.

UltraMel™ melatonin is produced exclusively for Physician’s Seal to conform to the company’s high standards and is about 10x the cost of commodity melatonin.

The sources of many other melatonin products on the market in the United States are often undisclosed or shipped from China or India.

Q: What is Ion Powered Pump (IPP)™ technology and how is it different from “time-released” or “bi-layer” melatonin products?

A: Ion Powered Pump (IPP)™ technology has revolutionized melatonin delivery to allow for a full 7-hour release and absorption of bioavailable melatonin.

Recent research has shown that conventional melatonin products have challenges being absorbed beyond the stomach, which may explain why other melatonin’s (including “time-released”) have difficulties with continuous absorption through the night.

The REMfresh® patented Ion Powered Pump (IPP)™ technology, is a continuous release and absorption system. This allows only REMfresh® to mimic the way the body naturally produces and maintains melatonin over a 7-hour period.

Q: How is REMfresh® different from other drug sleep products?

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

Q: How is REMfresh® different than other melatonin products?

A: Unlike conventional melatonin sleep products, REMfresh’s® continuous release and absorption technology is scientifically designed to mimic the body’s own melatonin profile using premium, ultra pure melatonin, UltraMel™.

The REMfresh® patented IPP™ technology sets it apart, as it helps to maintain melatonin levels for up to 7 hours, allowing for deep and restorative REM sleep as part of a full sleep cycle.

Remfresh®’s 7-hour absorption has been demonstrated in a well-designed clinical trial, REMAKT™[REM Absorption Kinetics Trial], vs. the leading conventional melatonin brand.16

REMfresh® has been granted two patents by the US Patent office which is an acknowledgment of the uniqueness and novelty of how REMfresh® works.

Q: Why is a continuous release and absorption melatonin needed?

A: The half-life of conventional melatonin is less than 60 minutes so sleep maintenance becomes a challenge. The patented IPP delivery system in REMfresh® moves its half-life beyond 3 hours.

Q: If there is a high Cmax, can there be tolerability issues with conventional melatonin?

A: No conclusive evidence is available. In the REMAKT trial, the treatment emergent adverse events (TEAE’s) in the conventional melatonin arm numbered 5 while the REMfresh® arm had none. All five TEAE’s were CNS or GI in nature. The Cmax in the conventional melatonin arm was more than 23x the targeted maintenance threshold of 1000 pg/ml while the Cmax of REMfresh® was less than 5x.

Q: Is REMfresh® approved by the FDA and is it safe?

A: 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.

Q: How do my patients take REMfresh®?

A: We suggest patients start with one 2 mg or 5 mg caplet of REMfresh® 30 to 60 minutes before desired bedtime. You should instruct your patients to titrate up until they achieved their desired results. Labeling suggest not to exceed 10mg per night. REMfresh® can be taken with or without food. REMfresh® works best as part of a patients individualized Sleep Hygiene Cycle™.

Everyone reacts differently to melatonin. A study done with a 2mg prolonged release melatonin product in Europe shows it may take up to 3 weeks to allow a fuller effect of melatonin.

Q: How will my patients feel when taking REMfresh®?

A: When patients take REMfresh®, they may feel ready for sleep within 30 minutes to an hour. If they wake
-up in the middle of the night while taking REMfresh® they may find it easier to fall asleep than with other melatonin products because of the unique release and absorption technology in REMfresh®. It is recommended the patient take REMfresh® when they are aiming for a fuller night’s sleep. The active ingredient in REMfresh®, melatonin, is neutralized by your patients morning production of cortisol. REMfresh® is designed so patients wake up refreshed.

Q: If my patients have certain food allergies and sensitivities; can they take REMfresh®?

A: REMfresh® has no added gluten, nuts, shellfish, or dairy products.

Q: Where and how is REMfresh® made?

A: REMfresh® is made in the United States, with UltraMel melatonin imported from Europe, under strict current Good Manufacturing Practices (cGMP). The manufacturing facilities are inspected by the 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.

Q: Can REMfresh® be taken by children?

A: REMfresh® is labeled for use by adults over the age of 18.

Q: Do I need to prescribe REMfresh® to my patients?

A: No. REMfresh® is available without a prescription at select drug stores and on REMfresh.com and Amazon.com.

Q: How can I get REMfresh® patient samples for my office?

A: To receive office samples please fill out the form below.

This information is for educational purposes only and is not meant to be a substitute for the advice of a physician or other healthcare professional. It has not been reviewed by the FDA. You should not use this information for diagnosing a health problem or disease. Individual results may vary. The company will strive to keep information current and consistent, but may not be able to do so at any specific time.

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