ZOLPIDEM TARTRATE - zolpidem tartrate tablet, extended release 
Aphena Pharma Solutions - Tennessee, LLC

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MEDICATION GUIDE

Zolpidem Tartrate (zole-PI-dem TAR-trate)

Extended-Release Tablets USP, 6.25 mg and 12.5 mg CIV

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:

People taking zolpidem tartrate extended-release tablets have reported:

Stop taking zolpidem tartrate extended-release tablet 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 is zolpidem tartrate extended-release tablet?

Zolpidem tartrate extended-release tablet is 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 tablet if you:

Before taking zolpidem tartrate extended-release tablet 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 works.

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:

  • See "What is the most important information I should know about zolpidem tartrate extended-release tablet ?"
  • Zolpidem tartrate extended-release tablet can make you sleepy or dizzy and can slow your thinking and motor skills . Next-day sleepiness is common, but can be serious. Because zolpidem tartrate extended-release tablet can make you sleepy or dizzy you are at a higher risk for falls.
    • Do not drive, operate heavy machinery, or do other dangerous activities until you know how zolpidem tartrate extended-release tablet affects you
    • Do not drink alcohol or take opioids or other medicines that may make you sleepy or dizzy while taking zolpidem tartrate extended-release tablet without first talking to your healthcare provider. When taken with alcohol or other medicines that cause sleepiness or dizziness, zolpidem tartrate extended-release tablet may make your sleepiness or dizziness much worse
  • 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 extended-release tablet.
  • Abnormal thoughts and behavior . Symptoms include more outgoing or aggressive behavior than normal, confusion (delirium), acting strangely, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions
  • Risk of suicide and worsening of depression . Worsening of depression, including suicidal thoughts and actions can happen during treatment with medicines like zolpidem tartrate extended-release tablets. Call your healthcare provider right away if you develop any thoughts of suicide, dying, or worsening depression during treatment with zolpidem tartrate extended-release tablet
  • Breathing problems . See "Before taking zolpidem tartrate extended-release tablets, tell your healthcare provider about all of your medical conditions, including if you :" Call your healthcare provider or get emergency medical help right away if you develop breathing problems during treatment with zolpidem tartrate extended-release tablets.
  • Problems with your nervous system caused by severe liver disease (hepatic encephalopathy)
  • Withdrawal symptoms . You may have withdrawal symptoms if you stop taking zolpidem tartrate extended-release tablets suddenly. Withdrawal symptoms can be serious and include stomach and muscle cramps, vomiting, sweating, shakiness, seizures, and confusion (delirium). Talk to your healthcare provider about slowly stopping zolpidem tartrate extended-release tablets to avoid withdrawal symptoms

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?

Store zolpidem tartrate extended-release tablets at room temperature, 59°F to 77°F (15°C to 25°C).

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

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

The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products.

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

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Goa 403 722

INDIA

Revised: April 2022                                                                                    ID #: 270217

Revised: 8/2023
Aphena Pharma Solutions - Tennessee, LLC