REMfresh® Study (CRA-melatonin™) Advances Use of Melatonin for Sleep Complaints

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.

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Decreased DNA Repair Links Shift Work and Increased Cancer Risk

MedicalResearch.com Interview with:
Parveen Bhatti, PhD
Associate Member
Fred Hutchinson Cancer Research Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Evidence in humans for an association between shift work and cancer has been mixed. This may be due to difficulties in accurately assessing long-term exposures to shift work in studies of cancer risk. We took a different approach that circumvented these difficulties. Rather than look at cancer risk directly, we measured, among actively employed shift workers, a marker of DNA damage that has been linked to cancer.

When repaired by cellular machinery, this particular marker is excreted in urine where it can be measured. We found that, compared to sleeping at night during their night off, shift workers had lower urinary levels of the DNA damage marker during their night work. This effect appears to be driven by reductions in circulating melatonin levels among shift workers during night work relative to night sleep. Given that melatonin has been shown to enhance repair of DNA damage, our results suggest that, during night work, shift workers have reduced ability to repair DNA damage resulting in lower levels being excreted in their urine. Because of this, shift workers likely have higher levels of DNA damage remaining in their cells, which can lead to mutations and cause cancer.

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Continuous Release REMfresh® Mimics Natural Melatonin Release

MedicalResearch.com Interview with:

David C. Brodner, M.D</strong>. 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®

Dr. Brodner

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: Chronic sleep and wakefulness disorders affect an estimated 50 to 70 million Americans, and long-term sleep deprivation has been associated with negative health consequences, including an increased risk of diabetes, hypertension, heart attack, stroke, obesity and depression.

Sleep/wake cycles are regulated by melatonin, levels of which 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 in triggered. Melatonin levels typically decline with age, with a significant decrease after age 40.

And as people age, their bodies may no longer produce enough melatonin to ensure adequate sleep. In addition to difficulties falling asleep, sleep in older populations can include fragmented and sustained sleep problems. Melatonin supplementation has been shown to promote and maintain sleep in older populations.

In this study, we compared the pharmacokinetics (PK) profile of REMfresh®, a continuous release and absorption melatonin (CRA-melatonin), with that of a leading immediate-release melatonin (IR-melatonin) formulation.

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Melatonin May Improve Blood Pressure Control Through Circadian Rhythm Regulation

MedicalResearch.com Interview with:
Dr. Denis Gubin
The Tyumen Medical University
Tyumen, Russia

MedicalResearch.com: What is the background for this study? What are the main findings? 

Dr. Gubin: The older we get, the more likely our circadian rhythms are disrupted. For example, blood pressure, BP, not only tends to increase but as well become more irregular.

One of the possible causes is an age-dependent deficit of endogenous melatonin production. We have shown that exogenous melatonin helps to ameliorate both trends – lowers  blood pressure and also stabilizes and synchronizes blood pressure and heart rate variability.
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Melatonin Has Endocrine Risks For Children

Dave Kennaway, PhD Professor, Lloyd Cox Senior Research Fellow, Head Circadian Physiology Laboratory School of Paediatrics and Reproductive Health Robinson Research Institute, Faculty of Health Sciences, Medical School, University of Adelaide AustraliaMedicalResearch.com Interview with:
Dave Kennaway, PhD Professor

Lloyd Cox Senior Research Fellow,
Head Circadian Physiology Laboratory
School of Paediatrics and Reproductive Health
Robinson Research Institute,
Faculty of Health Sciences, Medical School,
University of Adelaide Australia

MedicalResearch: What is the background for this review? What are the main findings?

Dr. Kennaway: There is evidence that melatonin is being prescribed to for sleep disorders in children and adolescents who are developing normally despite the fact that there have been no properly designed studies on the effects of prolonged administration to children. In countries where melatonin has been registered, it is for use as a monotherapy for the short term treatment of primary insomnia, characterised by poor quality of sleep in patients who are aged 55 years and over. Use in Paediatrics is always “off-label”. After more than 50 years of melatonin research in animals there is overwhelming evidence that melatonin administration affects many organ systems. These include important effects on the reproductive organs of rodents, cats, ruminants and primates and melatonin is in fact registered as a veterinary drug for this purpose. The effects of melatonin, however, go beyond the potential reproductive consequences, including effects on cardiovascular, immune and metabolic systems. It is clear that many paediatricians, practitioners and parents are unaware of this.

MedicalResearch: What should clinicians and patients take away from your report?

Dr. Kennaway: Clinicians and patients need to recognise that melatonin is a hormone and not a drug developed for a specific purpose or illness. There have been no appropriate trials in children addressing the effects of prolonged administration of melatonin in children. Given the extensive literature on the role of the hormone in normal physiology it is unlikely that such trials would ever be approved. Should endocrine or other abnormalities appear in the future in children previously treated with melatonin it will not be tenable to argue that we were surprised.

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IV Melatonin Did Not Reduce Surgical Pain

Lars Peter Holst Andersen MD., Ph.d. Fellow / Læge, Ph.d. studerende Department of Surgery Herlev Hospital Gastroenheden, Herlev HospitaMedicalResearch.com Interview with:
Lars Peter Holst Andersen MD., Ph.d. Fellow / Læge, Ph.d. studerende
Department of Surgery Herlev Hospital
Gastroenheden, Herlev Hospital

Medical Research: What is the background for this study?

Dr. Andersen: The sleep hormone, melatonin is diverse molecule. Several experimental animal studies have documented significant antinociceptive effects in a wide range of pain models. In perioperative medicine, administration of melatonin has demonstrated anxiolytic, analgesic and anti-oxidant effects. Optimization of the analgesic treatment in surgical patients is required due to documented inadequate analgesia and the risk of adverse effects and complications caused by commonly used NSAIDs and opioids. Our goal was to investigate if melatonin was able to reduce pain scores or analgesic use in patients undergoing laparoscopic cholecystectomy.
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Does Melatonin Prevent Delirium In Elderly Surgery Patients?

Annemarieke de Jonghe Academic Medical Center University of Amsterdam Departement of Internal Medicine Section of Geriatric Medicine F4-218 Amsterdam, The NetherlandsMedicalResearch.com Interview with:
Annemarieke de Jonghe
Academic Medical Center
University of Amsterdam
Departement of Internal Medicine
Section of Geriatric Medicine F4-218
Amsterdam, The Netherlands

Medical Research: What are the main findings of the study?

Dr. de Jonghe: We investigated the preventive properties of melatonin versus placebo in a prospective cohort of elderly hip fracture patients (n=378). We found that 3mg melatonin vs placebo, given for 5 days from the day of admission, did not influence the incidence of delirium. However, in a posthoc analysis we found that more patients in the placebo group more often had a longer lasting delirium.

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Melatonin Secretion and the Incidence of Type 2 Diabetes

 Dr. Ciaran McMullan MD from Channing Division of Network Medicine in Boston, a research division within the Department of Medicine at Brigham and Women’s Hospital, Boston MassMedicalResearch.com Interview with Dr. Ciaran McMullan MD
from Channing Division of Network Medicine in Boston, a research division within the Department of Medicine at Brigham and Women’s Hospital, Boston Mass

MedicalResearch.com: What are the main findings of the study?

Dr. McMullan: In this observational study performed in non-diabetic women we found that lower nocturnal melatonin secretion predicted future risk of developing type 2 diabetes. When we categorized the individuals by category of nocturnal melatonin secretion we found that those in the lowest category had twice the risk as those in the highest category of nocturnal melatonin secretion. This association remained even after adjusting for other well established risk factors for development of diabetes including body mass index, physical activity, dietary factors, family history of diabetes, smoking and hypertension. This increased risk translates into the lower melatonin secretion group having an additional 5 cases of incident diabetes per 1000 person years than the high melatonin secretion group.
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