Physician’s Seal LLC’s REMfresh Safety Update at 36 Months (REMSU36) is a post-marketing surveillance report on the safety and tolerability profile of REMfresh, a continuous release and absorption melatonin.
REMSU36 involves a post-marketing analysis of the adverse events voluntarily reported by users of a real-world surveillance program reporting on the safety and tolerability profile of REMfresh. It is estimated that 981,735 individual patients used the product during the three-year surveillance period of March 9, 2017 to March 9, 2020.
During that period, REMSU36 captured and analyzed serious and non-serious adverse event reports, and no serious adverse events were reported. The self-reporting rates and patterns of non-serious adverse events had 81 events recorded with non-serious events received from 81 patients. The four non-serious adverse events most commonly reported, were headache (7), dizziness (5), nightmares (4), and diarrhea (4). (Headaches, dizziness, and nightmares are often comorbid conditions for people experiencing from chronic sleeplessness and gastrointestinal systems can also be related to disrupting sleep and circadian function.)
“The findings from REMSU36 reaffirms the safety and tolerability profile of REMfresh in a real-world setting,” says David C. Brodner, MD, senior medical advisor for Physician’s Seal LLC, in a release. Brodner is a sleep specialist who is double board-certified in otolaryngology—head and neck surgery and sleep medicine, founder and principle physician at The Center for Sinus, Allergy, and Sleep Wellness, in Palm Beach County, Fla.