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REMfresh® Top FAQs

Tracking information for every REMfresh order is sent to the email provided upon purchase. If you created an account while purchasing, please login and click on ‘Orders’, a purchase note with the tracking information will be provided per order. Orders are shipped via FEDEX and status updates can be viewed using the FEDEX tracking tool on the following page https://www.fedex.com/apps/fedextrack/?action=track

When patients take REMfresh®, they may feel ready for sleep within 30 minutes to 90 minutes. If they wake up in the middle of the night while taking REMfresh®, they may find it easier to fall back asleep than with other melatonin products because of the unique release and absorption technology in REMfresh®. It is recommended that patients take REMfresh® when they are aiming for a fuller night’s sleep. The active ingredient in REMfresh®, melatonin, is neutralized by your patients’ morning production of cortisol. REMfresh®  is designed so patients wake up refreshed.

REMfresh®  has no added gluten, nuts, shellfish, or dairy products. REMfresh®  does contain dextrose monohydrate which is derived from wheat. Dextrose monohydrate is gluten free and is often used in gluten-free foods as a sweetener.

To receive patient samples, please call 1-617-470-8412, email Samples@REMfresh.com or visit REMfreshSamples.com

REFERENCES

  1. Colten H and Altevogt B. Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem. Washington, DC: Institute of Medicine, 2006.
  2. Ford D, Kamerow D, et al. Epidemiologic Study of Sleep Disturbances and Psychiatric Disorders. An opportunity for prevention? JAMA. 1989;262 (11):1989;262:1479-1484.
  3. Zhdanova IV, Wurtman RJ, Balcioglu A, Kartashov AI, Lynch HJ. Endogenous Melatonin Levels and the Fate

of Exogenous Melatonin: Age Effects. The Journals of Gerontology Series A: Biological Sciences and Medical Sciences.

1998; 53A.4.

  1. Ko DT, Herbert PR, Coffey CS, et al. Beta-blocker therapy and symptoms of depression, fatigue, and sexual dysfunction.

JAMA. 2002 Jul 17;288(3):351-7.

  1. Scheer FA, Morris CJ, Garcia JI, et al. Repeated melatonin supplementation improves sleep in hypertensive patients treated with beta-blockers: a randomized controlled trial. Sleep. 2012 Oct 1;35(10):1395-402.
  2. Nathan PJ, Maguire KP, Burrows GD, Norman TR. The effect of atenolol, a beta1-adrenergic antagonist, on nocturnal plasma melatonin secretion: Evidence for a dose-response relationship in humans. J Pineal Res. 1997;23:131-5
  3. Khanijow V et al. Sleep Dysfunction and Gastrointestinal Diseases. Gastroenterology & Hepatology. 2015 11.12 (2015): 817–825.
  4. Watson NF, Badr MS, Belenky G, et al. Joint Consensus Statement of the American Academy of Sleep Medicine and Sleep

Research Society on the Recommended Amount of Sleep for the Healthy Adult, Methodology and Discussion. J Clin

Sleep Med. 2015:11(6); 591-592.

  1. Kripke D, Garfinkel L, Wingard D, et al. Mortality Associated with Sleep Duration and Insomnia. Gen Psychiatry. 2002; 59:131-136.
  2. McIntyre I, Norman T, et al. Melatonin Rhythm in Human Plasma and Saliva. J Pineal Res. 1987; 4.2:177-83.
  3. Sack RL, Lewy AJ, Erb DL, Vollmer WM, Singer CM. Human Melatonin Production Decreases With Age. J Pineal

Res;1986 3.4: 379-88.

  1. Brodner DC, Shah SM. REM Absorption Kinetics Trial: A Randomized, Crossover, Pharmacokinetics Evaluation of a Novel Continuous Release and Absorption Melatonin Formulation versus a Same Strength Immediate-Release Formulation in Healthy Adults (Abstract 0396). Poster presented at: SLEEP 2017; June 3-7, 2017; Boston, MA.
  2. Hahm H, Kujawa J, and Augsburger L. Comparison of Melatonin Products Against USP’s Nutritional Supplements

Standards and Other Criteria. Journal of the American Pharmaceutical Association. 1996; 39.1: 27-31.

  1. Otmani S, Demazières A, Staner C, et al. Effects of Prolonged-release Melatonin, Zolpidem, and Their Combination on Psychomotor Functions, Memory Recall, and Driving Skills in Healthy Middle Aged and Elderly Volunteers. Human Psychopharmacology: Clinical and Experimental. 2008; 23.8: 693-705.
  2. Gray S, Anderson M, Dublin S, et al. Cumulative Use of Strong Anticholinergics and Incident Dementia. JAMA Internal

Medicine. 2015 175.3 : 401.

  1. Shah SM, Brodner DC. A Continuous Release Ion-Powered Pump® Melatonin Delivery System That Overcomes

Challenges of Release and Absorption in the Intestines (Abstract 0385). Poster presented at: SLEEP 2017; June 3-7,

2017; Boston, MA.

  1. European Medicines Agency. Assessment Report for CIRCADIN. 2007.

 

Start with 1 caplet of REMfresh®  30 to 90 minutes before desired bedtime. You should instruct your patients to titrate up until they achieve their desired results. Labeling suggests not to exceed 10 mg per night. REMfresh®  can be taken with or without food. REMfresh®  works best as part of a patient’s individualized Sleep Hygiene Cycle™.

Everyone reacts differently to melatonin. A study done with a 2 mg prolonged release melatonin product in Europe shows it should be taken up to 3 weeks to allow a fuller effect.17

No conclusive evidence is available. In the REMAKTTM trial, the treatment emergent adverse events (TEAE’s) in the conventional melatonin arm numbered 5 while the REMfresh®  arm had none. All 5 TEAE’s were CNS and GI in nature. The Cmax in the conventional melatonin arm was more than 23x the targeted maintenance threshold of 1000 pg/ml while the Cmax of REMfresh®  was less than 5x.

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