REMfresh Pharmacokinetics

REMfresh contains 2 mg of melatonin in a prolonged-release 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 a full night of deep, restorative sleep

In slow-metabolizing patients, this release profile minimizes the build up 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”

 REMfresh prolonged release formulation