REMfresh contains 2 mg of melatonin in a continuous-release and absorption formulation that has the following release characteristics designed for fast onset and sleep maintenance:†
Quick release and absorption of melatonin within the first hour after dosing, to obtain a faster onset of action†
A flat-topped (plateau) release profile—similar to the body’s own melatonin release profile— that exceeds 1000 pcg/ml plasma levels for up to 7 hours to help induce and maintain a full night of sleep including, deep restorative sleep†
In slow-metabolizing patients, this release profile minimizes the buildup of resistance to melatonin for sleep onset caused by the presence of metabolites associated with IR surge dosing†
A reliability of response, and maximum time of exposure above 1000 pcg/ml. This ensures a plasma concentration that is 10 times higher and enhances the likelihood of matching the exposure of melatonin in the brain during normal sleep†
A rapid decline of melatonin level in plasma at the 7-hour time point—similar to pre-dosing endogenous levels—that allows individuals to wake up refreshed and without a "drug hangover effect"†
Plasma Melatonin concentrations were measured 0-12 h after receiving 5 Mg of CRA-Melatonin or 5 Mg of IR-Melatonin.
Abbreviations: CRA-Melatonin = Continuous Release and Absorption
Approved after peer review and then published in Primary Care Companion for CNS Disorders, Aug 2019.
There are very few published studies of melatonin products currently in the market. This breakthrough study was recognized through the peer review process as one of the few to characterize how melatonin behaves in the body.
REMSU24 (REMfresh Safety Update at 24 Months) - an adverse event reporting rate of only 0.016% with no serious adverse events reported in an estimated 320,255 patients.
Made with UltraMel®, a 99% ultrapure melatonin sourced from Western Europe, where melatonin is regulated as a drug.
Part of an FDA Drug Master File.
Manufactured in FDA-inspected facilities (cGMP standards).