MEDICATION GUIDE

Zolpidem tartrate sublingual tablets C-IV

 (Zole-PI-dem TAR-trate)

Read this Medication Guide that comes with zolpidem tartrate sublingual 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 sublingual tablets?

• Do not take more zolpidem tartrate sublingual tablets than prescribed.
• Do not take zolpidem tartrate sublingual 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 sublingual tablets right before you get in bed, not sooner.

Zolpidem tartrate sublingual tablets may cause serious side effects, including:

• Complex sleep behaviors that have caused serious injury and death. After taking zolpidem tartrate sublingual 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 sublingual tablets whether or not you drink alcohol or take other medicines that make you sleepy.

       Reported activities include:

• driving a car (“sleep-driving”)
• making and eating food
• talking on the phone
• having sex
• sleep-walking

Stop taking zolpidem tartrate sublingual 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 sublingual tablets.

Do not take zolpidem tartrate sublingual tabletsif you:

• have ever experienced a complex sleep behavior (such as driving a car, making and eating food, talking on the phone, or having sex) while not being fully awake after taking zolpidem tartrate sublingual tablets
• drank alcohol that evening or before bed
• took another medicine to help you sleep

What are zolpidem tartrate sublingual tablets?

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

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

Zolpidem tartrate sublingual tablets are a class four (C-IV) federally controlled substance because it can be abused or lead to dependence. Keep zolpidem tartrate sublingual tablets in a safe place to prevent misuse and abuse. Selling or giving away zolpidem tartrate sublingual tablets may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take zolpidem tartrate sublingual tablets?

• Do not take zolpidem tartrate sublingual tablets if you are allergic to zolpidem or any other ingredients in zolpidem tartrate sublingual tablets. See the end of this Medication Guide for a complete list of ingredients in zolpidem tartrate sublingual tablets.
• Do not take zolpidem tartrate sublingual tablets if you have had an allergic reaction to drugs containing zolpidem, such as Ambien, Ambien CR, 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
• nausea and vomiting

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

Zolpidem tartrate sublingual tabletsmay not be right for you. Before starting zolpidem tartrate sublingual 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 lung disease or breathing problems
• are pregnant or planning to become pregnant. Talk to your healthcare provider about the risk to your unborn baby if you take zolpidem tartrate sublingual tablets.
• using zolpidem tartrate sublingual tablets in the last trimester of pregnancy may cause breathing difficulties or excess sleepiness in your newborn. Monitor for signs of sleepiness (more than usual), trouble breathing, or limpness in the newborn if zolpidem tartrate sublingual tablet is taken late in pregnancy.
• are breastfeeding or plan to breastfeed. Zolpidem tartrate passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while you take zolpidem tartrate sublingual 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 sublingual tabletswith other medicines that can make you sleepy, unless directed by your healthcare provider.

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 sublingual tablets?

• See “What is the most important information I should know about zolpidem tartrate sublingual tablets?”
• Take zolpidem tartrate sublingual tablets exactly as prescribed. Only take 1 zolpidem tartrate sublingual tablet a night and only if needed.
• Do not take zolpidem tartrate sublingual tablets if you drank alcohol that evening or before bed.
• You should not take zolpidem tartrate sublingual tablets with or right after a meal. Zolpidem tartrate sublingual tablets may help you fall asleep faster if you take it on an empty stomach.
• Do not use the tablet if the seal on the childproof blister pack is broken, or if the blister holding the tablet is broken.
• To open the blister pack, separate the individual blisters at the perforations. Peel off the top layer of paper, and push the tablet through the foil. Alternatively, use scissors to open the blister.
• Place the tablet under the tongue, where it will disintegrate. Do not swallow or take with water.
• 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 problem.
• If you take too much zolpidem tartrate or overdose, get emergency treatment.

What are the possible side effects of zolpidem tartrate sublingual tablets?

Zolpidem tartrate sublingual tabletsmay 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 sublingual tablets?”
• abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, suicidal thoughts or actions.
• memory loss
• anxiety
• severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing.

Get emergency medical help if you get these symptoms after taking zolpidem tartrate sublingual tablets.

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 sublingual tablets.

The most common side effects of zolpidem tartrate sublingual tabletsare:

• drowsiness
• dizziness
• diarrhea
• grogginess or feeling as if you have been drugged
• fatigue
• headache

You may still feel drowsy the next day after taking zolpidem tartrate sublingual tablets.

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

trouble sleeping lightheadedness stomach cramps stomach area pain

nausea uncontrolled crying panic attack

flushing vomiting nervousness

These are not all the side effects of zolpidem tartrate sublingual tablets. Ask your doctor 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 sublingual tablets?

• Store zolpidem tartrate sublingual tablets at room temperature, between 68° and 77°F (20° to 25°C).
• Protect from light and moisture.

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

General information about the safe and effective use of zolpidem tartrate sublingual tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

Do not use zolpidem tartrate sublingual tablets for a condition for which it was not prescribed.

Do not share zolpidem tartrate sublingual 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 sublingual 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 sublingual tablets that is written for healthcare professionals.

For more information about zolpidem tartrate sublingual tablets, go to www.parpharm.com or call Par Pharmaceutical at 1-800-828-9393.

What are the ingredients in zolpidem tartrate sublingual tablets?

Active Ingredient: zolpidem tartrate

Inactive Ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, mannitol, pregelatinized starch and saccharin sodium.

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

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Par Pharmaceutical.

Dist. by:

Par Pharmaceutical

Chestnut Ridge, NY 10977 U.S.A.

Mfg. by:

Par Formulations Private Limited,

9/215, Pudupakkam, Kelambakkam-603 103.

Made in India

Mfg. Lic. No.: TN00002121

OS903-01-74-03

Revised: 10/2019