MedicalResearch.com Interview with:
David C. Brodner, M.D.
Founder and Principle Physician, The Center for Sinus, Allergy, and Sleep Wellness
Double Board-Certified in Otolaryngology (Head and Neck Surgery) and Sleep Medicine
Assistant Clinical Professor, Florida Atlantic University College of Medicine
Medical Director, Good Samaritan Hospital Sleep Laboratory
Senior Medical Advisor, Physician’s Seal, LLC®
MedicalResearch.com: What is the background for this study?
Response: Melatonin is produced by the pineal gland in the brain and is the body’s natural sleep ingredient. Melatonin levels normally begin to rise in the mid-to late evening and remain high for the majority of the night. Levels begin to decline towards early morning, as the body’s wake cycle is triggered. Research shows that as people age, melatonin levels can drop by as much as 70 percent and their bodies may no longer produce enough melatonin to ensure adequate sleep.
Other available products, such as immediate-release melatonin, help initiate the onset of sleep but are usually unable to sustain prolonged sleep maintenance due to an immediate burst of melatonin, which is quickly degraded due to its relatively short half-life (60 minutes). Absorption in the lower digestive tract is limited by melatonin’s limited ability to be absorbed in a low acidity or neutral pH environment.
This post-marketing REMfresh® Patient Reported Outcomes DURation (REMDUR) study was designed to obtain real-world evidence about patients’ sleep patterns, duration of sleep before and after REMfresh® (CRA-melatonin™), daily REMfresh® (CRA-melatonin™) use, onset of action, sleep maintenance, quality of sleep, and overall satisfaction with REMfresh® (CRA-melatonin™). Patients with sleep disturbances in the general population who received a sample of CRA-melatonin™ (REMfresh®) from their physicians were invited to complete a 12-question survey. Survey responses were received from 500 patients.
MedicalResearch.com: What are the main findings?
Response: Our research demonstrated that a patient-reported outcomes study presented at SLEEP 2018 provides confirmatory real-world evidence of the previously peer-reviewed and presented data showing the 7-hour action of REMfresh®, a new product for sleep. REMfresh® Ion-Powered Melatonin™ is the first and only, continuous release and absorption melatonin™ (CRA-melatonin™) to mimic the body’s own 7-hour Mesa Wave™, the natural pattern of melatonin blood levels during a normal night’s sleep cycle. This induces sleep onset and provides lasting and restorative sleep for up to 7 hours.
This new data shows a correlative relationship between a 7-hour Mesa Wave™ pharmacokinetic (PK) profile and real-world evidence of improvements in sleep duration, onset, maintenance and sleep quality after taking REMfresh® (CRA-melatonin™).
The post-marketing REMfresh® Patient Reported Outcomes DURation (REMDUR) study was presented at SLEEP 2018, the 32nd Annual Meeting of the Associated Professional Sleep Societies (APSS), LLC, a joint partnership of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS). The research abstracts are published in the online supplement of the journal, Sleep, available at http://www.sleepmeeting.org/docs/default-source/default-document-library/abstractbook2018.pdf?sfvrsn=2.
In a sample of 500 patients on REMfresh® (CRA-melatonin™) responding to an online survey, 77.6 percent achieved 6 or more hours of sleep compared to 23.6 percent who slept that duration prior to taking REMfresh® (CRA-melatonin™) (p<.0001). A vast majority of respondents also reported a major or moderate improvement in sleep onset (91.6 percent, p<.0001), sleep maintenance (94.8 percent, p<.0001) and total sleep quality (97.2 percent, p<.0001). More than three-quarters (76.6 percent) of patients indicated they take REMfresh® (CRA-melatonin™) nightly. The proportion of patients reporting nightly CRA-melatonin™ use was significantly greater than the proportion of patients with less than nightly use (p<.0001). Most importantly, over 98 percent of patients reported they were very likely or likely to continue taking REMfresh® (CRA-melatonin™) to treat their sleep complaints.
MedicalResearch.com: What should readers take away from your report?
Response: The real-world evidence reported in the patient-reported outcomes study, REMfresh® Patient Reported Outcomes DURation (REMDUR), provides further confirmation that REMfresh® (CRA-melatonin™) represents a significant advance in the use of melatonin as a baseline therapy for treating sleep complaints. REMfresh® Ion-Powered Melatonin™ has been shown to be an effective drug-free solution that is now available to the millions of Americans in need of a good night’s sleep, many of whom seek new therapies that will induce sleep and keep them asleep until the morning, without causing residual effects they’ll feel the next day. With its unique delivery system that imitates the body’s own natural sleep pattern, REMfresh® (CRA-melatonin™) has revolutionized the role of melatonin, when delivered in the CRA form. It is no longer just a treatment for jet lag, but the CRA-melatonin™ found in REMfresh® (CRA-melatonin™) has been shown to provide substantial relief to individuals having nightly sleep challenges.
The scientifically advanced, patented delivery system in REMfresh® (CRA-melatonin™), called Ion Powered Pump™ (IPP™) technology, replicates the way in which the body naturally releases and absorbs melatonin, unlike conventional melatonin sleep products. Since REMfresh® (CRA-melatonin™) is not a drug, there is no drug hangover.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: : Larger studies on the effect of REMfresh® (CRA-melatonin™) in adults will add additional information to our body of knowledge.
Disclosures: Dr. Brodner is Senior Medical Advisor to Physician’s Seal®, the company that markets REMfresh® (CRA-melatonin™). Their web site is www.remfresh.com for further information on the product or connect with them on Facebook and YouTube.
SLEEP 2018 Poster
- (Abstract 0419) Improvement in Sleep Maintenance and Sleep Quality with Ion Powered Pump Continuous Release and Absorption Melatonin: Results from a Self-Reported Patient Outcomes Study
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