ZOLPIDEM TARTRATE - zolpidem tartrate tablet, film coated 
Aphena Pharma Solutions - Tennessee, LLC



 Zolpidem Tartrate Tablets, USP CIV
(zol' pi dem tar' trate)

Read the Medication Guide that comes with zolpidem tartrate 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?

Zolpidem tartrate may cause serious side effects, including:

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

Do not take
zolpidem tartrate if you:

What is zolpidem tartrate?

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

It is not known if zolpidem tartrate is safe and effective 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 in a safe place to prevent misuse and abuse. Selling or giving away zolpidem tartrate 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?

Symptoms of a serious allergic reaction to zolpidem can include:

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

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

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 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?

What are the possible side effects of zolpidem tartrate?

Zolpidem tartrate 
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.

The most common side effects of
zolpidem tartrate are:

After you stop taking a sleep medicine, you may have symptoms for 1 to 2 days such as:

These are not all the side effects of zolpidem tartrate. Ask your healthcare provider or pharmacist for more information.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store
zolpidem tartrate?

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

General Information about the safe and effective use of
zolpidem tartrate

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use zolpidem tartrate for a condition for which it was not prescribed. Do not share zolpidem tartrate 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. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about zolpidem tartrate that is written for healthcare professionals.

For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.

What are the ingredients in zolpidem
 tartrate tablets?

Active Ingredient:
Zolpidem tartrate

Inactive Ingredients:
lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide.

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

Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides

All brands listed are the trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.

Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810

Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahaboob Nagar (Dt)
509302, India

Revised: 04/2017

Revised: 9/2018
Aphena Pharma Solutions - Tennessee, LLC