MEDICATION GUIDE

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

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?

• Do not take more zolpidem tartrate extended-release tablets than prescribed.
• Do not take zolpidem tartrate extended-release tablets unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again.
• Take zolpidem tartrate extended-release tablets right before you get in bed, not sooner.

Zolpidem tartrate extended-release tablets may cause serious side effects that you may not know are happening to you. These side effects include:

• sleepiness during the day
• not thinking clearly
• act strangely, confused, or upset
• “sleep-walking” or doing other activities when you are asleep like:
• eating
• talking
• having sex
• driving a car

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:

• drank alcohol that evening or before bed
• take other medicines that can make you sleepy. Taking zolpidem tartrate extended-release tablets with other drugs can cause side effects. Talk to your healthcare provider about all of your medicines. Your healthcare provider will tell you if you can take zolpidem tartrate extended-release tablets with your other medicines.
• cannot get a full night’s sleep

What is 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:

• trouble falling asleep
• waking up often during the night

It is not known if zolpidem tartrate extended-release tablets are safe and effective in children under the age of 18 years.

Zolpidem tartrate extended-release tablets are a 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?

• Do not take zolpidem tartrate extended-release tablets if you are allergic to zolpidem or any other ingredients in zolpidem tartrate extended-release tablets. See the end of this Medication Guide for a complete list of ingredients in zolpidem tartrate extended-release tablets.
• Do not take zolpidem tartrate extended-release tablets if you have had an allergic reaction to drugs containing zolpidem, such as zolpidem tartrate, Edluar, Zolpimist, or Intermezzo.

Symptoms of a serious allergic reaction to zolpidem can include:

• swelling of your face, lips, and throat that may cause difficulty breathing or swallowing

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:

• have a history of depression, mental illness, or suicidal thoughts
• have a history of drug or alcohol abuse or addiction
• have kidney or liver disease
• have a lung disease or breathing problems
• are pregnant, planning to become pregnant. It is not known if zolpidem tartrate extended-release tablets will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Zolpidem tartrate extended-release tablets can pass into your breast milk. It is not known if zolpidem tartrate extended-release tablets will harm your baby. Talk to your healthcare provider about the best way to feed your baby while you take zolpidem tartrate extended-release 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 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?

• See “What is the most important information I should know about zolpidem tartrate extended-release tablets?”
• Take zolpidem tartrate extended-release tablets exactly as prescribed. Only take 1 zolpidem tartrate extended-release tablets a night if needed.
• Do not take zolpidem tartrate extended-release tablets if you drank alcohol that evening or before bed.
• You should not take zolpidem tartrate extended-release tablets with or right after a meal. Zolpidem tartrate extended-release tablets may help you fall asleep faster if you take it on an empty stomach.
• Take zolpidem tartrate extended-release tablets whole. Do not break, crush, dissolve or chew zolpidem tartrate extended-release tablets before swallowing. If you cannot swallow zolpidem tartrate extended-release tablets whole, tell your healthcare provider. You may need a different medicine.
• Call your healthcare provider if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problems.
• If you take too much zolpidem tartrate extended-release tablets or overdose, get emergency treatment.

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

Zolpidem tartrate extended-release tablets may cause serious side effects including:

• getting out of bed while not being fully awake and doing an activity that you do not know you are doing. (See “What is the most important information I should know about zolpidem tartrate extended-release tablets?”)
• abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions.
• memory loss
• anxiety
• 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 tablets.
• falls, which may lead to severe injuries

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:

• headache
• sleepiness
• dizziness
• drowsiness the next day after you take zolpidem tartrate extended-release tablets

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 extended-release tablets. 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 extended-release tablets?

Store zolpidem tartrate extended-release tablets at 20°C to 25°C (68°F 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 you think 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. To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

Active Ingredient: Zolpidem tartrate

Inactive Ingredients:
The 6.25 mg tablets contain:
colloidal silicon dioxide, D&C yellow #10 aluminum lake, FD&C yellow #6/sunset yellow FCF aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polyvinyl alcohol, sugar, titanium dioxide and talc.

The 12.5 mg tablets contain:
colloidal silicon dioxide, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, sugar, titanium dioxide and triacetin.

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

Manufactured by:

Par Pharmaceutical
Chestnut Ridge, NY 10977

R03/17    OS117A-01-50-10