The REMfresh Safety Update at 24 Months (REMSU24) study captured and analyzed serious and non-serious adverse event reports for REMfresh over a 24-month period from March 9, 2017 to March 9, 2019. The study found favorable results, and these results are now published in a supplement to the journal SLEEP and will be presented in August at Virtual SLEEP 2020.
No serious adverse events were reported. Additionally, the self-reporting rates and patterns of non-serious adverse events were very low with only 51 events recorded, a 0.016% event rate. The two most frequent, non-serious adverse events, headaches and nightmares, are known comorbidities of insomnia.
“The findings from REMSU24 are consistent with the outcome observed from REMSU12, which reaffirms the safety and tolerability profile of REMfresh in an extended and comprehensive real-world setting,” says David C. Brodner, MD, who is double board-certified in sleep medicine and otolaryngology—head and neck surgery, and senior Medical Advisor for Physician’s Seal LLC, the marketers of REMfresh, in a release.
Brodner, who is also founder at The Center for Sinus, Allergy, and Sleep Wellness, in Palm Beach County, Fla, adds, “This calculation results in an estimated 0.016% adverse event reporting rate for REMfresh, which is remarkably low. The outcome does not cause any concern for the safety profile of the product. This also confirms the benign safety and tolerability profile of REMfresh seen in prior studies and especially in the landmark REMAKT study where REMfresh showed superiority over the leading marketed, conventional melatonin product. In fact, the scatter of these non-serious adverse events in REMSU24 probably cannot be separated from what could be expected in the general population. More importantly, no pattern of next-morning drug hangover was seen.”
REMfresh is a continuous release and absorption (CRA) melatonin, designed to mimic the body’s own 7-hour Mesa Wave, the natural pattern of melatonin blood levels during a normal night’s sleep cycle.
REMfresh ranks for the third year as the #1 recommended modified-release melatonin brand, for the second year as the #1 recommended melatonin brand and for the first year as the #1 recommended nonprescription sleep aid brand overall by primary care physicians with certification in sleep disorders, according to an IQVIA ProVoice February-March 2020 survey.
“REMfresh 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 alternative therapies that will help induce sleep and keep them asleep until the morning, without causing residual effects they’ll feel the next day. Delivered with its patented Ion Powered Pump (IPP) technology, that imitates the body’s own natural sleep pattern, REMfresh is revolutionizing the role of melatonin. It is no longer just for jet lag, but the 99% ultrapure, CRA-melatonin found in REMfresh has been shown to provide substantial benefit to individuals having nightly sleep challenges,” says Brodner.