ZOLPIDEM TARTRATE- zolpidem tartrate tablet 
PD-Rx Pharmaceuticals, Inc.

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MEDICATION GUIDE

Zolpidem Tartrate (zole-PI-dem TAR-trate) Tablets, USP C-IV

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 healthcare provider about your medical condition or treatment.

What is the most important information I should know about zolpidem tartrate tablets?  

Zolpidem tartrate tablets may cause serious side effects, including:

o   driving a car ("sleep-driving")

o   making and eating food

o   talking on the phone

o   having sex

o   sleep-walking

Call your healthcare provider right away if you find out that you have done any of the above activities after taking zolpidem tartrate tablets.

Do not take zolpidem tartrate tablets if you:

What are zolpidem tartrate tablets?

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

Zolpidem tartrate tablets are not recommended for use in children under the age of 18 years.

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 healthcare provider if you have ever abused or have been dependent on alcohol, prescription medicines or street drugs. 

Who should not take zolpidem tartrate tablets?

Symptoms of a serious allergic reaction to zolpidem can include:

What should I tell my healthcare provider before taking zolpidem tartrate tablets?

Zolpidem tartrate tablets may not be right for you. Before starting zolpidem tartrate tablets, tell your healthcare provider about all of your health conditions, including if you:

Zolpidem tartrate tablets can pass into your breast milk. It is not known if zolpidem tartrate tablets will harm your baby. Talk to your healthcare provider about the best way to feed your baby while you take zolpidem tartrate tablets.

Tell your healthcare provider 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 unless  your healthcare provider tells you to.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.

How should I take zolpidem tartrate tablets?

What are the possible side effects of zolpidem tartrate tablets?

Zolpidem tartrate tablets may cause serious side effects, including:

Call your healthcare provider 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:

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

•   stomach area pain

These are not all the side effects of zolpidem tartrate tablets. Ask your healthcare provider 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?

Keep zolpidem tartrate tablets and all medicines out of reach of children.

General Information about the safe and effective use of 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 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 healthcare provider. You can ask your healthcare provider or pharmacist for information about zolpidem tartrate tablets that are written for healthcare professionals.

For more information, call 1-800-912-9561.

What are the ingredients in zolpidem tartrate tablets?

Active Ingredient: Zolpidem tartrate, USP

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.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Trademarks are the property of their respective owners.

Manufactured by:

TORRENT PHARMACEUTICALS LTD., INDIA.

Manufactured for

TORRENT PHARMA INC., Basking Ridge, NJ 07920.

8075161                                                                                  Revised April 2019

Revised: 7/2019
PD-Rx Pharmaceuticals, Inc.