ZOLPIDEM TARTRATE - zolpidem tartrate tablet, film coated, extended release 
Sun Pharmaceutical Industries, Inc.

----------

MEDICATION GUIDE




MEDICATION GUIDE

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

Read the Medication Guide that comes with zolpidem tartrate extended-release 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 extended-release tablets?


Zolpidem tartrate extended-release tablets may cause serious side effects including complex sleep behaviors that have caused serious injury and death. After taking zolpidem tartrate extended-release 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 (complex sleep behaviors). The next morning, you may not remember that you did anything during the night. These activities may occur with zolpidem tartrate extended-release tablets whether or not you drink alcohol or take other medicines that make you sleepy. Reported activities include:


Stop taking zolpidem tartrate extended-release tablets and call your healthcare provider right away if you find out that you have done any of the above activities after taking zolpidem tartrate extended-release tablets.

You should not drive a car or do things that require clear thinking the day after you take zolpidem tartrate extended-release tablets.

Do not take zolpidem tartrate extended-release tablets if you:


What are zolpidem tartrate extended-release tablets?

Zolpidem tartrate extended-release tablets are a sedative-hypnotic (sleep) medicine. Zolpidem tartrate extended-release tablets are used in adults for the treatment of a sleep problem called insomnia. Symptoms of insomnia include:


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



 Zolpidem tartrate extended-release tablets are federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep zolpidem tartrate extended-release tablets in a safe place to prevent misuse and abuse. Selling or giving away zolpidem tartrate extended-release 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 extended-release tablets?





Symptoms of a serious allergic reaction to zolpidem can include:


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

Zolpidem tartrate extended-release tablets may not be right for you. Before starting zolpidem tartrate extended-release tablets, 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 extended-release 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 extended-release tablets?

What are the possible side effects of zolpidem tartrate extended-release tablets?

Zolpidem tartrate extended-release 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 extended-release tablets.

The most common side effects of zolpidem tartrate extended-release tablets 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 extended-release 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 extended-release tablets?
Store zolpidem tartrate extended-release tablets at 20° to 25°C (68° to 77°F).

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


General Information about the safe and effective use of zolpidem tartrate extended-release tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use zolpidem tartrate extended-release tablets for a condition for which it was not prescribed. Do not share zolpidem tartrate extended-release 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 extended-release 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 extended-release tablets that is written for healthcare professionals.
For more information, call 1-800-818-4555.

What are the ingredients in zolpidem tartrate extended-release tablets? Active Ingredient: Zolpidem tartrate
Inactive Ingredients:
The 6.25 mg tablets contain: lactose monohydrate, microcrystalline cellulose, red ferric oxide, hypromellose, sodium starch glycolate, magnesium stearate, tartaric acid, talc, polyethylene glycol, polysorbate 80.
The 12.5 mg tablets contain: lactose monohydrate, microcrystalline cellulose, yellow ferric oxide, hypromellose, sodium starch glycolate, magnesium stearate, tartaric acid, talc, polyethylene glycol, polysorbate 80.
The imprinting ink contains shellac glaze, black iron oxide, propylene glycol, and ammonium hydroxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.
* All trademarks are the properties of their respective owners.

Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512

Manufactured by:
Sun Pharmaceutical Industries Limited
Survey No. 259/15,
Dadra-396 191, (U.T. of D & NH), India.
PGPI0247C
ISS. 09/2019




Revised: 9/2019
Sun Pharmaceutical Industries, Inc.