Sentrazolpidem PM-5 (Page 5 of 5)

13. NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, mutagenesis, impairment of fertility

13. NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, mutagenesis, impairment of fertility

Carcinogenesis: Zolpidem was administered to mice and rats for 2 years at dietary dosages of 4, 18, and 80 mg base/kg. In mice, these doses are approximately 2.5, 10, and 50 times the maximum recommended human dose (MRHD) of 10 mg/day (8 mg zolpidem base) on mg/m2 basis. In rats, these doses are approximately 5, 20, and 100 times the MRHD on a mg/m2 basis. No evidence of carcinogenic potential was observed in mice. In rats, renal tumors (lipoma, liposarcoma) were seen at the mid- and high doses.

Mutagenesis: Zolpidem was negative in in vitro (bacterial reverse mutation, mouse lymphoma, and chromosomal aberration) and in vivo (mouse micronucleus) genetic toxicology assays.

Impairment of fertility: Oral administration of zolpidem (doses of 4, 20, and 100 mg base/kg or approximately 5, 24, and 120 times the MRHD on a mg/m2 basis) to rats prior to and during mating, and continuing in females through postpartum day 25, resulted in irregular estrus cycles and prolonged precoital intervals. The no-effect dose for these findings is approximately 24 times the MRHD on a mg/m2 basis. There was no impairment of fertility at any dose tested.

14 CLINICAL STUDIES 14.1 Transient insomnia 14.2 Chronic insomnia 14.3 Studies pertinent to safety concerns for sedative/hypnotic drugs

14. CLINICAL STUDIES
14.1 Transient insomnia

Normal adults experiencing transient insomnia (n = 462) during the first night in a sleep laboratory were evaluated in a double-blind, parallel group, single-night trial comparing two doses of zolpidem (7.5 and 10 mg) and placebo. Both zolpidem doses were superior to placebo on objective (polysomnographic) measures of sleep latency, sleep duration, and number of awakenings.
Normal elderly adults (mean age 68) experiencing transient insomnia (n = 35) during the first two nights in a sleep laboratory were evaluated in a double-blind, crossover, 2-night trial comparing four doses of zolpidem (5, 10, 15 and 20 mg) and placebo. All zolpidem doses were superior to placebo on the two primary PSG parameters (sleep latency and efficiency) and all four subjective outcome measures (sleep duration, sleep latency, number of awakenings, and sleep quality).
14.2 Chronic insomnia

Zolpidem was evaluated in two controlled studies for the treatment of patients with chronic insomnia (most closely resembling primary insomnia, as defined in the APA Diagnostic and Statistical Manual of Mental Disorders, DSM-IV™). Adult outpatients with chronic insomnia (n = 75) were evaluated in a double-blind, parallel group, 5-week trial comparing two doses of zolpidem tartrate and placebo. On objective (polysomnographic) measures of sleep latency and sleep efficiency, zolpidem 10 mg was superior to placebo on sleep latency for the first 4 weeks and on sleep efficiency for weeks 2 and 4. Zolpidem was comparable to placebo on number of awakenings at both doses studied.
Adult outpatients (n=141) with chronic insomnia were also evaluated, in a double-blind, parallel group, 4-week trial comparing two doses of zolpidem and placebo. Zolpidem 10 mg was superior to placebo on a subjective measure of sleep latency for all 4 weeks, and on subjective measures of total sleep time, number of awakenings, and sleep quality for the first treatment week.
Increased wakefulness during the last third of the night as measured by polysomnography has not been observed in clinical trials with zolpidem tartrate tablets.
14.3 Studies pertinent to safety concerns for sedative/hypnotic drugs

Next-day residual effects: Next-day residual effects of zolpidem tartrate tablets were evaluated in seven studies involving normal subjects. In three studies in adults (including one study in a phase advance model of transient insomnia) and in one study in elderly subjects, a small but statistically significant decrease in performance was observed in the Digit Symbol Substitution Test (DSST) when compared to placebo. Studies of zolpidem tartrate tablets in non-elderly patients with insomnia did not detect evidence of next-day residual effects using the DSST, the Multiple Sleep Latency Test (MSLT), and patient ratings of alertness.
Rebound effects: There was no objective (polysomnographic) evidence of rebound insomnia at recommended doses seen in studies evaluating sleep on the nights following discontinuation of zolpidem tartrate tablets. There was subjective evidence of impaired sleep in the elderly on the first post-treatment night at doses above the recommended elderly dose of 5 mg.
Memory impairment: Controlled studies in adults utilizing objective measures of memory yielded no consistent evidence of next-day memory impairment following the administration of zolpidem tartrate tablets. However, in one study involving zolpidem doses of 10 and 20 mg, there was a significant decrease in next-morning recall of information presented to subjects during peak drug effect (90 minutes post-dose), i.e., these subjects experienced anterograde amnesia. There was also subjective evidence from adverse event data for anterograde amnesia occurring in association with the administration of zolpidem tartrate tablets, predominantly at doses above 10 mg.
Effects on sleep stages: In studies that measured the percentage of sleep time spent in each sleep stage, zolpidem tartrate tablets have generally been shown to preserve sleep stages. Sleep time spent in stages 3 and 4 (deep sleep) was found comparable to placebo with only inconsistent, minor changes in REM (paradoxical) sleep at the recommended dose.

16. HOW SUPPLIED/STORAGE AND HANDLING

16. HOW SUPPLIED/STORAGE AND HANDLING

Zolpidem tartrate 5 mg tablets are red colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘5 MG’ debossed on the other side and supplied as:
NDC Number Size
13668-007-30 bottle of 30
13668-007-90 bottle of 90
13668-007-01 bottle of 100
13668-007-05 bottle of 500
13668-007-10 bottle of 1000
13668-007-15 bottle of 1500
13668-007-74 carton of 100 unit dose
Zolpidem tartrate 10 mg tablets are peach-yellow colored, capsule shaped tablets with the Torrent logo debossed on one side and ‘10 MG’ debossed on the other side and supplied as:
NDC Number Size
13668-008-30 bottle of 30
13668-008-90 bottle of 90
13668-008-01 bottle of 100
13668-008-05 bottle of 500
13668-008-10 bottle of 1000
13668-008-15 bottle of 1500
13668-008-74 carton of 100 unit dose

Store at 20°-25°C (68°-77°F); excursions permitted to 15° — 30°C (59°- 86°F) [see USP Controlled Room Temperature].

17. PATIENT COUNSELING INFORMATION 17.1 Severe anaphylactoid reactions 17.2 Sleep-driving and other complex behaviors 17.3 Administration instructions 17.4 Medication Guide

17. PATIENT COUNSELING INFORMATION

Prescribers or other healthcare professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with sedative-hypnotics, should counsel them in its appropriate use, and should instruct them to read the accompanying Medication Guide [see Medication Guide (17.4)].
17.1 Severe anaphylactoid reactions

Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with zolpidem. Describe the signs/symptoms of these reactions and advise patients to seek medical attention immediately if any of them occur.
17.2 Sleep-driving and other complex behaviors

There have been reports of people getting out of bed after taking a sedative-hypnotic and driving their cars while not fully awake, often with no memory of the event. If a patient experiences such an episode, it should be reported to his or her doctor immediately, since “sleep-driving” can be dangerous. This behavior is more likely to occur when zolpidem tartrate tablets are taken with alcohol or other central nervous system depressants [see Warnings and Precautions (5.3)]. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with “sleep-driving”, patients usually do not remember these events.
In addition, patients should be advised to report all concomitant medications to the prescriber. Patients should be instructed to report events such as “sleep-driving” and other complex behaviors immediately to the prescriber.
17.3 Administration instructions

Patients should be counseled to take zolpidem tartrate tablets right before they get into bed and only when they are able to stay in bed a full night (7-8 hours) before being active again. Zolpidem tartrate tablets should not be taken with or immediately after a meal. Advise patients NOT to take zolpidem tartrate tablets when drinking alcohol.
17.4 Medication Guide

Read the Medication Guide that comes with zolpidem tartrate tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.
What is the most important information I should know about zolpidem tartrate tablets?
After taking zolpidem tartrate tablets, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with zolpidem tartrate tablets. Reported activities include:
• driving a car (“sleep-driving”)
• making and eating food
• talking on the phone
• having sex
• sleep-walking

Call your doctor right away if you find out that you have done any of the above activities after taking zolpidem tartrate tablets.
Important:
1. Take zolpidem tartrate tablets exactly as prescribed
• Do not take more zolpidem tartrate tablets than prescribed.
• Take zolpidem tartrate tablets right before you get in bed, not sooner.

2. Do not take zolpidem tartrate tablets if you:
• drink alcohol
• take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take zolpidem tartrate tablets with your other medicines.
• cannot get a full night’s sleep

What are zolpidem tartrate tablets?
Zolpidem tartrate tablets are a sedative-hypnotic (sleep) medicine. Zolpidem tartrate tablets are used in adults for the short-term treatment of a sleep problem called insomnia. Symptoms of insomnia include:
• trouble falling asleep

Zolpidem tartrate tablets are not for children.
Zolpidem tartrate is a federally controlled substance (C-IV)
because it can be abused or lead to dependence. Keep
zolpidem tartrate tablets in a safe place to prevent misuse
and abuse. Selling or giving away zolpidem tartrate tablets
may harm others, and is against the law. Tell your doctor if
you have ever abused or have been dependent on alcohol,
prescription medicines or street drugs.
Who should not take zolpidem tartrate tablets?
Do not take zolpidem tartrate tablets if you are allergic to anything in it.
See the end of this Medication Guide for a complete list of ingredients in zolpidem tartrate tablets.
Zolpidem tartrate tablets may not be right for you. Before starting zolpidem tartrate tablets, tell your doctor about all of your health conditions, including if you:
• have a history of depression, mental illness, or suicidal thoughts
• have a history of drug or alcohol abuse or addiction
• have kidney or liver disease
• have a lung disease or breathing problems
• are pregnant, planning to become pregnant, or breastfeeding

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects. Do not take zolpidem tartrate tablets with other medicines that can make you sleepy.
Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
How should I take zolpidem tartrate tablets?
• Take zolpidem tartrate tablets exactly as prescribed. Do not take more zolpidem tartrate tablets than prescribed for you.
• Take zolpidem tartrate tablets right before you get into bed.
• Do not take zolpidem tartrate tablets unless you are able to stay in bed a full night (7-8 hours) before you must be active again.
• For faster sleep onset, zolpidem tartrate tablets should NOT be taken with or immediately after a meal.
• Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.
• If you take too much zolpidem tartrate tablets or overdose, call your doctor or poison control center right away, or get emergency treatment.

What are the possible side effects of zolpidem tartrate tablets?
Serious side effects of zolpidem tartrate tablets include:
• getting out of bed while not being fully awake and do an activity that you do not know you are doing. (See “What is the most important information I should know about zolpidem tartrate tablets?)
• abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions.
• memory loss
• anxiety
• severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking zolpidem tartrate tablets.

Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using zolpidem tartrate tablets.
The most common side effects of zolpidem tartrate tablets are:
• drowsiness
• dizziness
• diarrhea
• “drugged feelings”
• You may still feel drowsy the next day after taking zolpidem tartrate tablets. Do not drive or do other dangerous activities after taking zolpidem tartrate tablets until you feel fully awake.

After you stop taking a sleep medicine, you may have symptoms for 1 to 2 days such as: trouble sleeping, nausea, flushing, lightheadedness, uncontrolled crying, vomiting, stomach cramps, panic attack, nervousness, and stomach area pain.
These are not all the side effects of zolpidem tartrate tablets. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–1088.
How should I store zolpidem tartrate tablets?
• Store at 20°-25°C (68°-77°F); excursions permitted to 15° — 30°C (59°- 86°F) [see USP Controlled Room Temperature].
• Keep zolpidem tartrate tablets and all medicines out of reach of children.

General Information about zolpidem tartrate tablets
• Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
• Do not use zolpidem tartrate tablets for a condition for which it was not prescribed.
• Do not share zolpidem tartrate tablets with other people, even if you think they have the same symptoms that you have. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about zolpidem tartrate tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about zolpidem tartrate tablets that is written for healthcare professionals. For more information about zolpidem tartrate tablets, call 1-269-544-2299.
What are the ingredients in zolpidem tartrate tablets?
Active Ingredient: Zolpidem tartrate
Inactive Ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also contains ferric oxide yellow.
Rx Only
This Medication Guide has been approved by the U.S. Food and Drug Administration.

Torrent

Manufactured by:
TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA.
For:
TORRENT PHARMA INC., 5380 Holiday Terrace, Suite 40,
Kalamazoo, Michigan 49009.
8023534

500 Tablets NDC 13668-007-05

Zolpidem Tartrate Tablets IV

5 mg

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Each tablet contains 5 mg of zolpidem tartrate. Rx only

Store at 20°-25°C (68°-77°F); excursions permitted to 15° — 30°C (59°- 86°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant, child-resistant container.

Usual Adult Dosage:

See accompanying prescribing information.

Torrent Mfg. Lic. No. : G/926

Manufactured by:

TORRENT PHARMACEUTICALS LTD.

Indrad-382 721, Dist. Mehsana, INDIA.

For:

TORRENT PHARMA INC.

5380 Holiday Terrace, Suite 40 Kalamazoo, Michigan 49009.

N3 13668-007-05 3

Batch :

EXP :


8021719

Sentra PM™PRODUCT INFORMATION
Sentra PM (U.S. patent pending) capsules by oral administration. A specially formulated Medical Food product, consisting of a proprietary blend of amino acids and polyphenol ingredients in specific proportions, for the dietary management of the metabolic processes of sleep disorders (SD). Must be administered under physician supervision.
Medical Foods Medical Food products are often used in hospitals (e.g., for burn victims or kidney dialysis patients) and outside of a hospital setting under a physician’s care for the dietary management of diseases in patients with particular medical or metabolic needs due to their disease or condition. Congress defined “Medical Food” in the Orphan Drug Act and Amendments of 1988 as “a system which is formulated to be consumed or administered enterally [or orally] under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” Medical Foods are complex formulated products, requiring sophisticated and exacting technology. Sentra PM has been developed, manufactured, and labeled in accordance with both the statutory and the FDA regulatory definition of a Medical Food. Sentra PM must be used while the patient is under the ongoing care of a physician.
SLEEP DISORDERS (SD)
SD as a Metabolic Deficiency Disease A critical component of the definition of a Medical Food is the requirement for a distinctive nutritional deficiency. FDA scientists have proposed a physiologic definition of a distinctive nutritional deficiency as follows: “the dietary management of patients with specific diseases requires, in some instances, the ability to meet nutritional requirements that differ substantially from the needs of healthy persons. For example, in establishing the recommended dietary allowances for general, healthy population, the Food and Nutrition Board of the Institute of Medicine National Academy of Sciences, recognized that different or distinctive physiologic requirements may exist for certain persons with “special nutritional needs arising from metabolic disorders, chronic diseases, injuries, premature birth, other medical conditions and drug therapies. Thus, the distinctive nutritional needs associated with a disease reflect the total amount needed by a healthy person to support life or maintain homeostasis, adjusted for the distinctive changes in the nutritional needs of the patient as a result of the effects of the disease process on absorption, metabolism, and excretion.” It was also proposed that in patients with certain disease states who respond to nutritional therapies, a physiologic deficiency of the nutrient is assumed to exist. For example, if a patient with sleep disorders responds to a tryptophan formulation by improving the duration and quality of sleep, a deficiency of tryptophan is assumed to exist.
Patients with sleep disorders are known to have nutritional deficiencies of tryptophan, choline, flavonoids, and certain antioxidants. Patients with sleep disorders frequently exhibit reduced plasma levels of tryptophan and have been shown to respond to oral administration of tryptophan or a 5-hydoxytryptophan formulation. Research has shown that tryptophan reduced diets result in a fall of circulating tryptophan. Patients with sleep disorders have activation of the tryptophan degradation pathway that increases the turnover of tryptophan leading to a reduced level of production of serotonin for a given tryptophan blood level. Research has also shown that a genetic predisposition can lead to increased tryptophan requirements in certain patients with sleep disorders.
Choline is required to fully potentiate acetylcholine synthesis by brain neurons. A deficiency of choline leads to reduced acetylcholine production by the neurons. Low fat diets, frequently used by patients with sleep disorders, are usually choline deficient. Flavonoids potentiate the production of acetylcholine by the neurons thereby inducing REM sleep. Low fat diets and diets deficient in flavonoid rich foods result in inadequate flavonoid concentrations, impeding acetylcholine production in certain patients with sleep disorders. Provision of tryptophan, choline, and flavonoids with antioxidants, in specific proportions can restore the production of beneficial serotonin and acetylcholine, thereby improving sleep quality.

PRODUCT DESCRIPTION
Primary Ingredients
Sentra PM consists of a proprietary blend of amino acids, cocoa, ginkgo biloba and flavonoids in specific proportions. These ingredients fall into the category of “Generally Regarded as Safe” (GRAS) as defined by the Food and Drug Administration (FDA) (Sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act). A GRAS substance is distinguished from a food additive on the basis of the common knowledge about the safety of the substance for its intended use. The standard for an ingredient to achieve GRAS status requires not only technical demonstration of non-toxicity and safety, but also general recognition of safety through widespread usage and agreement of that safety by experts in the field. Many ingredients have been determined by the U.S. Food and Drug Administration (FDA) to be GRAS, and are listed as such by regulation, in Volume 21 Code of Federal Regulations (CFR) Sections 182, 184, and 186.
Amino Acids
Amino Acids are the building blocks of protein. All amino acids are GRAS listed as they have been ingested by humans for thousands of years. The doses of the amino acids in Sentra PM are equivalent to those found in the usual human diet; however the formulation uses specific ratios of the key ingredients to elicit a therapeutic response. Patients with sleep disorders may require an increased amount of certain amino acids that cannot be obtained from normal diet alone. Tryptophan, for example, is an obligatory amino acid. The body cannot make tryptophan and must obtain tryptophan from the diet. Tryptophan is needed to produce serotonin. Serotonin is required to induce sleep. Patients with sleep disorders have altered serotonin metabolism. Some patients with sleep disorders have a resistance to the use of tryptophan that is similar to the mechanism found in insulin resistance that is genetically determined. Patients with sleep disorders frequently cannot acquire sufficient tryptophan from the diet without ingesting a prohibitively large amount of calories, particularly protein rich calories.
Flavonoids
Flavonoids are a group of phytochemical compounds found in all vascular plants including fruits and vegetables. They are a part of a larger class of compounds known as polyphenols. Many of the therapeutic or health benefits of colored fruits and vegetables, cocoa, red wine, and green tea are directly related to their flavonoid content. The specially formulated flavonoids found in Sentra PM cannot be obtained from conventional foods in the necessary proportions to elicit a therapeutic response.
Other Ingredients
Sentra PM contains the following inactive or other ingredients, as fillers, excipients, and colorings: magnesium stearate, microcrystalline cellulose, Maltodextrin NF, gelatin (as the capsule material).
Physical Description
Sentra PM is a yellow to light brown powder. Sentra PM contains L-Glutamic Acid, 5-Hydroxytryptophan as Griffonia Seed Extract, Acetylcarnitine HCL, Choline Bitartrate, Cinnamon, Cocoa, Ginkgo Biloba, and Hawthorn Berry.

CLINICAL PHARMACOLOGY
Mechanism of Action
Sentra PM acts by restoring and maintaining the balance of the neurotransmitters, serotonin and acetylcholine, that are associated with sleep disorders.
Metabolism
The amino acids in Sentra PM are primarily absorbed by the stomach and small intestines. All cells metabolize the amino acids in Sentra PM. Circulating tryptophan and choline blood levels determine the production of serotonin and acetylcholine.
Excretion
Sentra PM is not an inhibitor of cytochrome P450 1A2, 2C9, 2C19, 2D6, or 3A4. These isoenzymes are principally responsible for 95% of all detoxification of drugs, with CYP3A4 being responsible for detoxification of roughly 50% of drugs. Amino acids do not appear to have an effect on drug metabolizing enzymes.

INDICATIONS FOR USE
Sentra PM is intended for the clinical dietary management of the metabolic processes associated with sleep disorders.

CLINICAL EXPERIENCE
The administration of Sentra PM has demonstrated significant functional improvement in the quality and quantity of sleep when used for the dietary management of the metabolic processes associated with sleep disorders. Administration of Sentra PM results in the induction and maintenance of sleep in patients with sleep disorders. Sentra PM has no effect on normal blood pressure.

PRECAUTIONS AND CONTRAINDICATIONS
Sentra PM is contraindicated in an extremely small number of patients with hypersensitivity to any of the nutritional components of Sentra PM.

ADVERSE REACTIONS
Oral supplementation with L-tryptophan or choline at high doses up to 15 grams daily is generally well tolerated. The most common adverse reactions of higher doses — from 15 to 30 grams daily — are nausea, abdominal cramps, and diarrhea. Some patients may experience these symptoms at lower doses. The total combined amount of amino acids in each Sentra PM capsule does not exceed 400 mg.

DRUG INTERACTIONS
Sentra PM does not directly influence the pharmacokinetics of prescription drugs. Clinical experience has shown that administration of Sentra PM may allow for lowering the dose of co-administered drugs under physician supervision.

OVERDOSE
There is a negligible risk of overdose with Sentra PM as the total dosage of amino acids in a one month supply (60 capsules) is less than 24 grams. Overdose symptoms may include diarrhea, weakness, and nausea.
POST-MARKETING SURVEILLANCE
Post-marketing surveillance has shown no serious adverse reactions. Reported cases of mild rash and itching may have been associated with allergies to Sentra PM flavonoid ingredients, including cinnamon, cocoa, and chocolate. The reactions were transient in nature and subsided within 24 hours.

DOSAGE AND ADMINISTRATION
Recommended Administration For the dietary management of the metabolic processes associated with sleep disorders. Take (2) capsules daily at bedtime. An additional dose of one or two capsules may be taken after awakenings during the night. As with most amino acid formulations Sentra PM should be taken without food to increase the absorption of key ingredients.

How Supplied
Sentra PM is supplied in red and white, size 0 capsules in bottles of 60 capsules.
Physician Supervision
Sentra PM is a Medical Food product available by prescription only and must be used while the patient is under ongoing physician supervision.
Sentra PM is supplied to physicians in a recyclable plastic bottle with a child-resistant cap.
U.S. patents pending.
Manufactured by Arizona Nutritional Supplements, Inc. Chandler AZ 85225
Distributed by Physician Therapeutics LLC, Los Angeles, CA 90077. www.ptlcentral.com
© Copyright 2003-2006, Physician Therapeutics LLC, all rights reserved
NDC # 68405-1003-02

Storage
Store at room temperature, 59-86OF (15-30OC). Protect from light and moisture.

PHYSICIAN THERAPEUTICS SENTRA PM Medical Food Rx only 60 Capsules Directions for use: Must be administered under medical supervision. For adults only. As a Medical Food, take two (2) capsules at bedtime or as directed by your medical practitioner. For the dietary management of sleep disorders. Contains no added sugar, starch, wheat, yeast, preservatives, artificial color or flavor. Storage: Keep tightly closed in a cool dry place 8-320 C (45-900F), relative humidity, below 50%. Warning: Keep this product out of the reach of children. NDC# 68405-1003-02 Ingredients: Each serving (2 capsules) contains: Proprietary Amino Acid blend Choline Bitartrate, Glutamic Acid (L-Glutamic Acid), Cocoa Extract (fruit), Proprietary Herbal Blend Ginkgo Biloba (leaves), Griffonia Seed Extract (5-HTP), Hawthorn Berry (fruit), Acetyl L-Carnitine HCl, Dextrose Other Ingredients: Gelatin, Cellulose, Dicalcium Phosphate, Silicon Dioxide and Vegetable Magnesium Stearate.
Distributed by: Physician Therapeutics LLC, Los Angeles, CA 90077 www.ptlcentral.com Patent Pending

68405-023-26 For the Dietary Management of Sleep Disorders Associated with Depression.. Two capsules at bedtime or as directed by physician. See product label and insert. Sentra PM Medical Food PHYSICIAN THERAPEUTICS Sentra PM + Zolpidem 5 mg A Convenience Packed Medical Food and Drug Sentrazolpidem PM-5 PHYSICIAN THERAPEUTICS — Sentra PM 60 Capsules — Zolpidem 5 mg 30 Tablets No Refills Without Physician Authorization Rx Only NDC# 68405-023-26 of this co-pack As prescribed by physician. See product label and product information insert. Zolpidem 5 mg Rx Drug Manufactured and Distributed by Physician Therapeutics, A Division of Targeted Medical Pharma Inc. Los Angeles, CA 90077 www.ptlcentral.com B-NDC# 68405-8023-26

Sentra PM
(click image for full-size original)

ZolpidemLabel
(click image for full-size original)

Sentrazolpidem
(click image for full-size original)

SENTRAZOLPIDEM PM-5 zolpidem tartrate, choline kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68405-023
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68405-023-26 1 KIT (KIT) in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 30
Part 2 1 BOTTLE 60
Part 1 of 2
ZOLPIDEM TARTRATE zolpidem tartrate tablet
Product Information
Item Code (Source) NDC:52959-879(NDC:13668-007)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZOLPIDEM TARTRATE (ZOLPIDEM) ZOLPIDEM TARTRATE 5 mg
Product Characteristics
Color red (RED) Score no score
Shape CAPSULE Size 10mm
Flavor Imprint Code 5MG
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52959-879-30 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077903 07/07/2011
Part 2 of 2
SENTRA PM choline capsule
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHOLINE (CHOLINE) CHOLINE 250 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
MALTODEXTRIN
GELATIN
Product Characteristics
Color red (RED) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code ;
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 60 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Medical Food 07/07/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/07/2011
Labeler — Physician Therapeutics LLC (931940964)
Establishment
Name Address ID/FEI Operations
Torrent Pharmaceuticals Limited 916488547 manufacture
Establishment
Name Address ID/FEI Operations
H.J. Harkins Company, Inc 147681894 repack
Establishment
Name Address ID/FEI Operations
Targeted Medical Pharma, Inc. 126962740 manufacture

Revised: 08/2011 Physician Therapeutics LLC

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