ZOLPIDEM TARTRATE- zolpidem tartrate tablet, extended release 
Breckenridge Pharmaceutical, Inc.

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MEDICATION GUIDE

ZOLPIDEM TARTRATE (zole-PI-dem TAR-trate)
EXTENDED-RELEASE TABLETS,
for oral use, C-IV

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:

Stop taking Zolpidem tartrate extended-release tablets and tell 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.

What are zolpidem tartrate extended-release tablets?

Zolpidem tartrate extended-release tablets are a prescription sleep medicine used for the treatment of adults who have trouble falling asleep or staying asleep (insomnia).

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

Before taking zolpidem tartrate extended-release tablets, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Zolpidem tartrate extended-release tablets and other medicines can interact with each other causing serious side effects. Zolpidem tartrate extended-release tablets may affect the way other medicines work, and other medicines may affect how zolpidem tartrate extended-release tablets work.

Especially tell your healthcare provider if you:

You can ask your pharmacist for a list of medicines that interact with zolpidem tartrate extended-release tablets.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when 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:

The most common side effects of zolpidem tartrate extended-release tablets include headache and dizziness. These are not all the side effects of zolpidem tartrate extended-release tablets.

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?

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 give zolpidem tartrate extended-release tablets to other people, even if they have the same symptoms that you have. It may harm them. 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, go to www.bpirx.com or call 1-800-367-3395.

What are the ingredients in zolpidem tartrate extended-release tablets?

Active Ingredient: zolpidem tartrate

Inactive Ingredients:

The 6.25 mg zolpidem tartrate extended-release tablets contain: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, ferric oxide yellow, magnesium stearate, potassium bitartrate, hypromellose, colloidal silicon dioxide, titanium dioxide, polyethylene glycol, FD&C Red #40.

The 12.5 mg zolpidem tartrate extended-release tablets contain: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, ferric oxide red, magnesium stearate, potassium bitartrate, hypromellose, colloidal silicon dioxide, titanium dioxide, polyethylene glycol, FD&C Blue #2.

The brands listed are trademarks of their respective owners.

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

Manufactured by:
Centaur Pharmaceuticals Pvt. Ltd.
Pune - 411 057, INDIA.

Distributed by:
Breckenridge Pharmaceutical, Inc.
Berlin, CT 06037

Revised: 02/2022

211887

Revised: 7/2023
Breckenridge Pharmaceutical, Inc.