Primary Care Companion for CNS Disorders has published results of a US-based randomized, crossover pharmacokinetic (PK) evaluation study in healthy, non-smoking adults, called REMAKT (REM Absorption Kinetics Trial), that compared REMfresh continuous-release and absorption melatonin (CRA-melatonin) with an immediate-release melatonin (IR-melatonin).

The researchers observed melatonin blood levels that mimicked the body’s own natural pattern of melatonin, according to REMfresh marketer Physician’s Seal, which adds that this is enabled by the patented Ion-Powered Pump technology in REMfresh that allows melatonin to be continuously released and absorbed through the gastrointestinal track for up to 7 hours.

The study, “A Randomized, Crossover, Pharmacokinetics Evaluation of a Novel Continuous Release and Absorption Melatonin Formulation,” demonstrated that melatonin levels with REMfresh exceeded the targeted sleep maintenance threshold for a median of 6.7 hours, compared with 3.7 hours for IR-melatonin. Conversely, the levels of the IR-melatonin formulation dramatically increased 23 times greater than the targeted sleep maintenance threshold level, and then had a rapid decline in serum levels that did not allow melatonin levels to be maintained beyond 4 hours.

“This study represents an important step forward in addressing the public health issue of the cumulative effects of sleep loss,” says David J. Seiden, MD, medical director for the Baptist Health Sleep Centers of South Florida in Pembroke Pines, in a release. “In this study, REMfresh was shown to achieve quick release and then continuous release and absorption of melatonin for up to 7 hours, which, besides helping with sleep onset, may help to improve sleep maintenance and morning alertness. Most importantly, this study is an important advancement in the use of melatonin, not only as a chronobiotic, but potentially with drug-free hypnotic effects to initiate and maintain sleep.”

The 7-hour action of REMfresh has been validated by two real-world, patient-reported outcomes (PRO) studies, REMfresh Patient Reported Outcomes DURation (REMDUR) and REMfresh Duration Validation (REMVAL). Both of these studies, involving a total of over 1,600 patients, have been peer reviewed, accepted, and presented at SLEEP 2018 and SLEEP 2019, respectively. Both of these studies demonstrated significant user benefit in sleep onset, sleep duration and sleep quality when taking REMfresh.

Over 5,000 healthcare practitioners are estimated to have used REMfresh for their patients and about 320,000 patients are estimated to have purchased and used REMfresh.