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Medical Food Classification Sentra PM™ is a Medical Food formulated by practicing physicians to meet the nutritional requirements for inducing sleep, promoting restorative sleep, and reducing snoring in patients who have sleep problems associated with depression. Sentra PM™ provides the amino acids that are precursors to the neurotransmitters that have been depleted in humans. Restoration of these depleted neurotransmitters aid in the induction of sleep, promotion of restorative sleep and reduction in snoring. Under the regulations of the Food and Drug Administration, Medical Foods may only be used when a patient is under the ongoing care of a physician or other healthcare professional. Medical Foods are used for the dietary management of disease states with known nutritional deficiencies. Medical Foods must contain ingredients found in the human diet and cannot be sold directly to patients or used without medical supervision. Distinctive Nutritional Requirements Indications for Use
Neurotransmitter Production from Nutrients in the Human Body
Targeted Cellular Technology This unique five-component process allows milligram quantities of neurotransmitter precursors to enter the cells and produce the required neurotransmitters. This process includes a neurotransmitter precursor, an uptake stimulator, a neuron activator, an adenosine brake inhibitor, and attenuation releaser. Previous attempts to use neurotransmitter precursors have required much larger quantities of the precursors to elicit a therapeutic effect making it functionally impossible for a patient to ingest large gram quantities of a precursor agent on a daily basis. The use of the Targeted Cellular Technology process also prevents the development of tolerance. Unlike pharmaceutical agents that lose their effectiveness in a relatively short period, Sentra PM™ maintains its effectiveness and does not attenuate. Sentra PM™ Ingredients: Targeted Cellular Technology and Sentra PM™ Sentra PM™ is designed to produce the neurotransmitters serotonin and acetylcholine Serotonin is the neurotransmitter that initiates sleep. Acetylcholine is the neurotransmitter that maintains Delta IV-V deep sleep and facilitates REM sleep. Sentra PM™ is designed to provide serotonin and acetylcholine precursors to enhance the production of the serotonin and acetylcholine neurotransmitters. Sentra PM™ and Clinical Testing Physiologic testing of autonomic nervous system function has been performed on individuals taking Sentra PM™. Patients without sleep disorders display normal parasympathetic activation during sleep as measured by heart rate variability analysis. Normal parasympathetic function results in restorative sleep. Patients with sleep disorders display reduced parasympathetic activity. There have been two open label trials of Sentra PM™ Dosage One or two capsules of Sentra PM™ should be taken daily at bedtime. An additional dose of Sentra PM™ can be used if the patient awakens during the night and cannot fall back to sleep. As with all Medical Food products, the best dosing protocol is established by the healthcare provider in coordination with the requirements of each individual. Sentra PM™ and Prescription Drugs In patients taking pharmaceutical agents to induce and maintain sleep, it is suggested that the medication dosage should be reduced gradually. Sentra PM™ should be taken with the pharmaceutical sleep agent at bedtime. If restorative sleep is obtained with the combination, the drug should be slowly tapered off under medical supervision. Side Effects The side effect profile of Sentra PM™ is comparable to the rate of food intolerance in the community. The ingredients of Sentra PM™ are derived from nutrient based compounds found in the normal food chain. Food intolerance is an adverse reaction to food that does not involve the body's immune system. When first starting any amino acid therapy, some people complain of mild headaches, stomach upset, or mouth dryness. These symptoms are mild and temporary and can be managed by drinking plenty of fluids and carefully titrating the dose. Rarely, some individuals feel jittery or over-stimulated. These side effects are relieved by lowering the dose. Background: Sentra PM™ contains a formula blend of selected GRAS (generally regarded as safe) ingredients that are found in the human food chain. The primary ingredients are key amino acids, the building blocks of proteins. The Sentra PM™ formula is designed to induce increased neurotransmitter function in patients with sleep disorders. The The Sentra PM™ formula is based on a five-component patent pending process. The patent pending process provides for a five-component system to allow for the conversion of a neurotransmitter precursor into a neurotransmitter. The five component system includes: (1) each neurotransmitter is synthesized from an amino acid precursor, (2) stimulation of the uptake of the neurotransmitter precursor is required to initiate the conversion of a precursor to a neurotransmitter, (3) since most neurons are inhibited from firing, an adenosine antagonist such as and cocoa powder is added to disinhibit the neuron, (4) stimulation of neurons to release a specific neurotransmitter is required, and (5) a system must be used to prevent attenuation of the precursor response, a well known precursor phenomena. Sentra PM™ has been formulated to encompass this five-component system. The Sentra PM™ formula targets the neurotransmitters acetylcholine and serotonin. Sentra PM™ is designed to produce acetylcholine and serotonin, two of the neurotransmitters that are involved in sleep disorders(1-62) (51;63-104) (105-117). If the timing and secretion of these three neurotransmitters are altered, normal sleep cycles and restorative sleep do not occur. For example the benzodiazepine drugs, including Ambien, reduce sleep latency, but abolish phase IV-V sleep and REM sleep. Sentra PM™ is designed to produce neurotransmitters related to physiologic functions including initiation of sleep, maintenance of sleep, and re-induction of sleep upon awakening during the night. In the Sentra PM™ formulation, choline is used as a precursor to acetylcholine and 5-hydroxytryptophan is used to induce the physiologic production of serotonin(118);. Thus, the Sentra PM™ formula contains the neurotransmitter precursor In the Sentra PM™ formula, Ginkgo Biloba is used as an uptake stimulator(119-124). Glutamic acid is used to produce glutamate, a neuronal stimulator(125-156). Cocoa is used to disinhibit the adenosine break(157-167) (168-171). Grape seed extract, containing polyphenols(172-175), is used to avoid the attenuation usually associated with neurotransmitter precursor administration. Release of serotonin initiates sleep and reduces latency (10;13;20;27;38;46;75;78;82;187-222) (51;55;94;223-241). The timing of serotonin release is critical to initiation of sleep. The amount of serotonin released is critical to initiation of sleep. At the initiation of sleep, a small amount of serotonin is released. The amount of serotonin peaks within several hours after sleep initiation. The failure to produce serotonin, the production of insufficient serotonin, or the production of excessive amounts of serotonin will result in the failure to initiate sleep. Serotonin is intimately involved in sleep apnea, snoring, REM sleep, and depression associated with sleep disorders(20;84;197;242-288) (244;244;285;285;289-297;297;298;298;299;299-302;302-306;306-311;311-330) (331-350). An alteration of the tryptophan/serotonin axis will result in altered sleep patterns. Appropriate and timely production of serotonin will ameliorate sleep disorders. Production of acetylcholine after initiation of sleep results in production of restorative Delta IV-V sleep(51;78;88;94;103;351-393). Following the burst of serotonin that initiates sleep, acetylcholine release increases the duration of phase IV and V restorative sleep. In addition, the release of acetylcholine increases the frequency of REM episodes and the duration of these episodes. The commonly used hypnotic drugs including Ambien abolish phase IV and V sleep and inhibit REM sleep.
Accordingly, the Sentra PM™ formula contains precise proprietary amounts of The Sentra PM™ formula is designed to provide precursors for known neurotransmitters that induce and maintain restorative sleep. The amino acid precursors are Nutritional Deficiency Associated with Sleep Disorders Patients with sleep disorders frequently exhibit nutritional deficiencies of tryptophan, choline, and sometimes GABA. Patients with sleep disorders often have reduced blood levels of serotonin(58;433-462) and 5-hydroxytryptophan. Moreover, obese patients use more tryptophan than lean patients do. Reduced calorie diets that are frequently low in protein, result in a further fall in blood tryptophan, and can exacerbate sleep disorders. Thus, patients with sleep disorders are frequently deficient in tryptophan. (463-489). There is an alteration of tryptophan metabolism in patients with sleep disorders(490;491;491-497;497-506;506-508;508;509;509-513;513-528;528;529;529-535;535-578) (579;580;580-586;586-591;591-598;598-606;606-610;610-638). Choline deficiency is associated with sleep disorders(88;91;94;212;228;356;399;639-655) (656-659), particularly those associated with sleep apnea syndromes(31;31;660;660-665;665-677;677-692;692-695;695;696;696-698;698-734). © 2006 Physician Therapeutics LLC & Nationwide Medical Foods
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Sentra PM™ Product Information 
