Physicians Seal LLC announced favorable results from its REMfresh Safety Update at 12 Months (REMSU-12) for REMfresh Ion-Powered Melatonin, a real-world surveillance study reporting on the safety and tolerability profile of REMfresh (CRA-melatonin). It is estimated that 87,467 individual patients used the product since the beginning of the surveillance. No serious adverse events were reported. Additionally, the self-reporting rates and patterns of non-serious adverse events were very low with only 15 events received. The two top-reported, non-serious adverse events were pruritis and dizziness. According to Physician’s Seal, the robust scientific literature on melatonin does not show that REMfresh is known to cause any of these non-serious adverse events.

REMSU-12 captured and analyzed serious and non-serious adverse event reports for REMfresh (CRA-melatonin) over a 12-month period from March 9, 2017 to March 9, 2018.

“The findings from REMSU-12 reaffirm the safety and tolerability profile of REMfresh (CRA-melatonin) in real-world settings,” says David C. Brodner, MD, a sleep specialist who is double board-certified in otolaryngology—head and neck surgery and sleep medicine, in a release. Brodner is also founder and principle physician at The Center for Sinus, Allergy, and Sleep Wellness, in Palm Beach County, Fla, and senior medical advisor for Physician’s Seal. “This calculation results in an estimated 0.02% adverse event reporting rate for REMfresh (CRA-melatonin), which is remarkably low. More importantly, no pattern of next morning drug hangover was seen. This confirms the extremely benign side-effect profile of REMfresh seen in two prior studies.”

REMfresh is a continuous release and absorption melatonin (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 (CRA-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 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 has been shown to provide substantial relief to individuals having nightly sleep challenges,” Brodner says.

Approximately 3.5 million REMfresh caplets were sold in the United States during a 12-month period from March 9, 2017 to March 9, 2018.

An independent call center with pharmacovigilance-trained health care personnel in accordance with US Food and Drug Administration (FDA) and global regulatory guidelines on properly reporting events was retained to receive and record REMfresh customer questions, product issues, and adverse events. In addition, a 12-month cluster analysis and trend analysis of adverse events reports received for REMfresh was conducted by the same personnel. The adverse events for this study were collected and processed from March 9, 2017 to March 9, 2018.

REMfresh is available as 2 mg and 5 mg and with a 0.5 mg anticipated in the second half of 2018.

REMfresh is a dietary supplement and is regulated under the Federal Dietary Supplement Health and Education Act, which does not require pre-approval.