RestoREM. Product Monograph

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Arlene Maryann Fields
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1 RestoREM Product Monograph RestoREM is composed of dietary supplements that help with balancing neurochemistry and increasing rest and relaxation to improve sleep and sleep quality. Supplement Facts Serving Size: 1 Capsule Servings Per Container: 30 Ingredients Amount Per Serving % Daily Value Formula Use(s) 5-HTP (5-hydroxytryptophan) 25 mg * Helps increase serotonin pools Helps with relaxation and improved sleep patterns Helps reduce cravings for carbohydrates/sugar Phenibut (β-phenyl-γ-aminobutyric acid) 200 mg * Improves GABA levels and increases relaxation/sleep Melatonin 5 mg * Natural hormone for sleep Cycles Antioxidant * Daily value not established. Recommended Uses: Helps balance neurochemistry and increase rest and relaxation to improve sleep and sleep quality. Recommended Dosages: 1-2 capsules, 1 hour before bedtime as needed.

2 Product Overview: Sleep is essential to a balanced metabolism. Sleep helps regulate circadian rhythms, including learning and memory, cellular repair, regulation of immunity, core body temperature, melatonin secretion by the pineal gland and plasma levels of DHEA and cortisol. 1 Sleep disorders include: o Insomnia o Obstructive sleep apnea o Night-eating syndrome o Restless leg syndrome o Narcolepsy Research has reported that most individuals should obtain at least 7-9 hours of quality sleep a night (Centers for Disease Control, CDC, 2011). 2 Less than the recommended 7-8 hours of uninterrupted sleep can lead to health consequences including: 3,4,5,6,7,8,9 o Increased inflammatory signaling/oxidative stress o Increased cardiovascular disease risk, including hyperlipidemia, hypertension, endothelial dysfunction, increase mortality from CVD o Gastrointestinal imbalances o Increased bone loss o Insulin signaling sensitivity/type 2 diabetes o Increase musculoskeletal aches/pains o Neurochemical imbalances o Weight gain/food cravings o Immune imbalances o Sex and thyroid hormone imbalances o Cancer 67% of Americans experience frequent problems sleeping and 43% say lack of sleep interferes with their daily activities. Between 9-12% of the population are clinically diagnosed with insomnia. 10,11 RestoREM contains the nutrients 5-HTP, Phenibut and melatonin. 5-HTP, or 5- hydroxytryptophan, helps improve serotonin levels and improve relaxation and sleep patterns. Phenibut, or β -Phenyl-γ-aminobutyric acid, is reported to help improve GABA levels. GABA is an inhibitory neurotransmitter that has been reported to be low in approximately 30% of the insomnia population. 12,13 Melatonin is a naturally occuring hormone produced in the brain that helps improve the sleep/wake cycle so maximum rest is achieved. Melatonin helps to reset the cortisol circadian rhythms. Sleep disturbance is thought to be what is known as a hyper arousal syndrome of the brain, in other words the brain is too excited as a result of daytime activities and cannot appropriately decrease vigilance or excitability at night.

3 Supporting Research: 5-Hydroxytryptophan (5-HTP) 5-hydroxytryptophan (5-HTP) is an amino acid Supports serotonin levels that is the precursor of the neurotransmitter Helps with mood/relaxation serotonin and is made from the amino acid L- Helps improve sleep patterns tryptophan. 5-HTP is also a precursor for melatonin and niacin. 5-HTP is important in the ability to support normal production of serotonin in the brain. 14,15 Clinical studies show that 5-HTP supplementation can positively affect mood and emotional well-being. 16,17 Clinical trials have also reported decreases in overall food intake and a subsequent reduction in weight in individuals taking 5-HTP. 18 Phenibut (β -Phenyl-γ-aminobutyric acid) Phenibut, or β -Phenyl-γ-aminobutyric acid, is a derivative of the naturally occurring inhibitory neurotransmitter gamma-aminobutyric acid (GABA). The addition of a phenyl ring to the GABA chemical structure allows Phenibut to readily cross the blood brain barrier. Phenibut is reported to stimulate dopamine receptors and antagonize betaphenethylamine (PEA), an endogenous anxiogenic agent. 19 Melatonin Melatonin is a methoxyindole hormone that is produced in the pineal gland in the brain. It is synthesized from L-tryptophan in the diet, which is converted into 5- Acts as a GABA-mimetic, primarily at GABA B and, to some extent, at GABA A receptors Anxiolytic Nootropic Naturally occurring hormone that helps improve sleep patterns Antioxidant; helps improve immunity hydroxytrytophan then into melatonin. Melatonin is reported to help regulate sleep/wake cycles and circadian rhythms including cortisol patterns. 20,21 Melatonin also helps improve immunity and is an antioxidant. 22 Melatonin levels decrease with increasing age. Other conditions that may lower melatonin levels include jet lag, night shift working, chronic stress and some medications. The following medications are reported to potentially deplete melatonin levels in the body: Beta-blockers Calcium channel blockers Benzodiazepines Estrogen-containing medications Hydralazine Loop diuretics Theophylline Antidepressants, including SSRI (Selective serotonin reuptake inhibitors) NSAIDs (Non-steroidal anti-inflammatory drugs)

4 Toxicity, Contraindications, or Side Effects: There is no known toxicity or side effects from taking ingredients found in RestoREM. RestoREM may cause drowsiness, so use caution when driving an automobile or operating heavy machinery when using RestoREM. Talk with your doctor or pharmacist before taking RestoREM if you have a preexisting medical condition and/or if you are taking prescription or nonprescription medications. DISCLAIMER: Statements made are for educational purposes and have not been evaluated by the US Food and Drug Administration. They are not intended to diagnose, treat, cure, or prevent any disease. 1 Kalsbeek A, van der Spek R, Lei J, et al. Circadian rhythms in the hypothalamic-pituitary-adrenal (HPA) axis. Mol Cell Endocrinol. 2012;349(1): Centers for Disease Control (CDC). Accessed September Gangwisch JE, Malaspina D, Babiss LA, et al. Short sleep duration as a risk factor for hypercholesterolemia: analyses of the National Longitudinal Study of Adolescent Health. Sleep. 2010;33(7): Chaput JP, Despres JP, Bouchard C, Astrup A, Tremblay A. Sleep duration as a risk factor for the development of type 2 diabetes or impaired glucose tolerance: analyses of the Quebec Family Study. Sleep Med. 2009;10(8): Chaput JP, Despres JP, Bouchard C, Tremblay A. Association of sleep duration with type 2 diabetes and impaired glucose tolerance. Diabetologia. 2007;50(11): Eisenbruch S, Thompson JJ, Hamish MJ, et al. Behavioral and psychological sleep characteristics in women with irritable bowel syndrome. Am J Gastroenterol. 2002;97(9): Irwin M. Effects of sleep and sleep loss on immunity and cytokines. Brain Behav Immun. 2002;16(5): Troxel WM, Buysse DJ, Matthews KA, et al. Sleep. 2010;33(12): Gangwisch JE, Malaspina D, Boden-Albala B, et al. Inadequate sleep as a risk factor for obesity: analyses of the NHANES I. Sleep. 2005;28(10): National Sleep Foundation Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002;6(2): Winkelman JW, Buxton OM, Jensen JE, et al. Reduced brain GABA in primary insomnia: preliminary data from 4T proton magnetic resonance spectroscopy (1H-MRS). Sleep. 2008;31(11): Plante DT, Jensen JE, Schoerning L, et al. Reduced y-aminobutyric acid in occipital and anterior cingulate cortices in primary insomnia: a link to major depressive disorder? Neuropsychopharmacology. 2012;37(6): Cangiano C, Laviano A, Del Ben M, et al. Effects of oral 5-hydroxy-tryptophan on energy intake and macronutrient selection in non-insulin dependent diabetic patients. Int J Obes Relat Metab Disord. 1998;22: Birdsall, T. C Hydroxytryptophan: a clinically-effective serotonin precursor. Alternative Medicine Review 3: Murphy SE, Longhitano C, Ayres RE, et al. Tryptophan supplementation induces a positive bias in the processing of emotional material in healthy female volunteers. Psychopharmacology (Berl). 2006;187(1): Lowe SL, Yeo KP, Teng L, Soon DK, Pan A, Wise SD, Peck RW. L-5-Hydroxytryptophan augments the neuroendocrine response to a SSRI. Psychoneuroendocrinology. 2006;31(4): Cangiano, C., Ceci, F., Cairella, M., Cascino, A., Del Ben, M., Laviano, A., Muscaritoli, M. and Rossi- Fanelli, F Effects of 5-hydroxytryptophan on eating behavior and adherence to dietary prescriptions in obese adult subjects. Adv Exp Biol Med 294 ("Kynurenine and Serotonin Pathways"):

5 19 Lapin I. Phnibut (beta-phenyl-gaba): a traaquilizer and nootropic drug. CNS Drug Rev. 2001;7(4): Zhdanova IV, Wurtman RJ, Regan MM, et al. Melatonin treatment for age-related insomnia. J Clin Endocrinol Metab. 2001;86(10): Kostoglou-Athanassiou I. Therapeutic applications of melatonin. Ther Adv Endocrinol Metab. 2013;4(1): Galano A, Tan DX, Reiter RJ. Melatonin as a natural ally against oxidative stress: a physicochemical examination. J Pineal Res. 2011;51(1):1-16.

Neurochemistry in Sleep and its Clinical Manifestations

Neurochemistry in Sleep and its Clinical Manifestations CATHERINE KIER, MD Professor of Clinical Pediatrics Division Chief, Pediatric Pulmonary, and Cystic Fibrosis Center Director, Pediatric Sleep Disorders