A drug-free, nonprescription sleep product that continuously releases and absorbs melatonin extended melatonin-targeted sleep maintenance levels in the body to 6.7 hours, according to findings presented in three posters at the annual SLEEP meeting.
The continuous release and absorption melatonin product (REMfresh, Physician’s Seal LLC) uses novel ion-powered pump technology to replicate the body’s natural pattern of melatonin blood levels during a typical night’s sleep cycle, resulting in lasting, restorative sleep up to 7 hours, according to David C. Brodner, MD, senior medical adviser for Physician’s Seal LLC and principal physician at the Center for Sinus, Allergy and Sleep Wellness, and Syed M. Shah, PhD, from Physician’s Seal LLC, who co-wrote the data presented at SLEEP 2017.
The REM Absorption Kinetic Trial (REMAKT), a randomized, pharmacokinetic evaluation study, compared the pharmacokinetic profiles of REMfresh with that of a leading immediate-release melatonin (IR-melatonin) in 10 healthy adults aged 18 to 40 years. Participants received 5 mg REMfresh or 5 mg IR-melatonin formulation, with pharmacokinetic parameters determined through monitoring of melatonin levels in the blood before the first dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8 and 12 hours following.
REMAKT found that REMfresh demonstrated continuous release and absorption of 99% ultra-pure melatonin release and absurd melatonin. Melatonin levels with REMfresh exceeded the targeted sleep maintenance threshold of 1,000 pm/mL for a median of 6.7 hours compared with 3.7 hours for the leading IR-melatonin. REMfresh facilitated sleep onset with a burst of release and absorption of roughly 50% of the melatonin within the first 3 hours, then sustained about 50% of the remaining melatonin within the next 4 hours to help maintain sleep. The IR-melatonin formulation levels increased dramatically to 23 times greater than the targeted levels of exogenous melatonin for sleep maintenance then had a rapid decline in serum levels, resulting in melatonin levels that could not be maintained beyond 4 hours.
These findings build on evidence from prolonged-release melatonin studies, which have shown improvement in sleep quality, morning alertness and quality of life in patients aged 55 years and older compared with placebo.
“These results represent an unparalleled breakthrough in drug-free sleep maintenance therapy that physicians and their patients have been waiting for,” Brodner said in a press release. “Melatonin products have been used primarily as a chronobiotic to address sleep disorders associated with abnormal timing of the circadian system, such as jet lag and shift work, but that has now changed… REMfresh may allow more individuals having trouble sleeping to experience drug-free, consistent, restorative sleep and have an improved quality of life.” – by Savannah Demko
Brodner DC, Shah SM. Abstract 0388. Presented at: SLEEP 2017; June 3-7; Boston.
Brodner DC, Shah SM. Abstract 0396. Presented at: SLEEP 2017; June 3-7; Boston.
Shah SM, Brodner DC. Abstract 0385. Presented at: SLEEP 2017; June 3-7; Boston.
Disclosures: Brodner and Shah report they are advisers for Physician’s Seal LLC. The study was funded by Physician’s Seal LLC.