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:

1.

Complex sleep behaviors. 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. The next morning, you may not remember that you did anything during the night. These activities may happen with zolpidem tartrate extended-release tablets whether or not you drink alcohol or take other medicines that make you sleepy. Some of these complex sleep behaviors have caused serious injury and death. People taking zolpidem tartrate extended-release tablets have reported:

1.

sleep-walking

2.

sleep-driving

3.

making and eating food

4.

talking on the phone

5.

having sex

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).

1.

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 not recommended for use in children under the age of 18 years.

2.

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 protect it from theft. Never give your zolpidem tartrate extended-release tablets to anyone else because it can cause death or harm them. Selling or giving away this medicine is against the law.

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

1.

have had complex sleep behaviors that happened after taking zolpidem tartrate extended-release tablets in the past. See "Error! Hyperlink reference not valid."

2.

are allergic to zolpidem or any of the 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.

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

1.

have a history of depression, mental illness, or suicidal thoughts or actions

2.

have a history of drug or alcohol abuse or addiction

3.

have kidney or liver disease

4.

have a lung disease or breathing problems

5.

have sleep apnea

6.

have myasthenia gravis

7.

are pregnant or plan to become pregnant. Taking zolpidem tartrate extended-release tablets in the third trimester of pregnancy may harm your unborn baby.

1.

Tell your healthcare provider if you become pregnant or plan to become pregnant during treatment with zolpidem tartrate extended-release tablets.

2.

Babies born to mothers who take zolpidem tartrate extended-release tablets during the third trimester of pregnancy may have symptoms of breathing problems and sedation (such as sleepiness or low muscle tone).

8.

are breastfeeding or plan to breastfeed. Zolpidem tartrate extended-release tablets pass into your breast milk. 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 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:

1.

take benzodiazepines

2.

take opioids as it may increase the risk of breathing problems (respiratory depression).

3.

take tricyclic antidepressants

4.

take other medicines that can make you sleepy or affect your breathing (including other zolpidem medicines)

5.

drink alcohol

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?

1.

Take zolpidem tartrate extended-release tablets exactly as prescribed. Do not change your dose on your own. Tell your healthcare provider if you think zolpidem tartrate extended-release tablets are not working for you.

2.

Zolpidem tartrate extended-release tablets are for short-term use only. Treatment with zolpidem tartrate extended-release tablets should be as short as possible because the risk of dependence increases the longer you are being treated.

3.

Take 1 zolpidem tartrate extended-release tablet a night right before bedtime.

4.

Do not take zolpidem tartrate extended-release tablets if you are not able to stay in bed a full night (7 to 8 hours) before you must be active again.

5.

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.

6.

Do not take zolpidem tartrate extended-release tablets if you drank alcohol that evening or before bed.

7.

Swallow zolpidem tartrate extended-release tablets whole. Do not divide, crush, or chew zolpidem tartrate extended-release tablets. If you cannot swallow zolpidem tartrate extended-release tablets whole, tell your healthcare provider. You may need a different medicine.

8.

Call your healthcare provider if your sleep problems get worse or do not get better within 7 to 10 days. This may mean that there is another condition causing your sleep problems.

9.

If you take too many zolpidem tartrate extended-release tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

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

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

1.

See "Error! Hyperlink reference not valid."

2.

Zolpidem tartrate extended-release tablets 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 tablets can make you sleepy or dizzy you are at a higher risk for falls.

1.

Do not drive, operate heavy machinery, or do other dangerous activities until you know how zolpidem tartrate extended-release tablets affects you.

2.

Do not drink alcohol or take opioids or other medicines that may make you sleepy or dizzy while taking zolpidem tartrate extended-release tablets without first talking to your healthcare provider. When taken with alcohol or other medicines that cause sleepiness or dizziness, zolpidem tartrate extended-release tablets may make your sleepiness or dizziness much worse.

3.

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.

4.

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.

5.

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 tablets.

6.

Breathing problems. See "Error! Hyperlink reference not valid." Call your healthcare provider or get emergency medical help right away if you develop breathing problems during treatment with zolpidem tartrate extended-release tablets.

7.

Problems with your nervous system caused by severe liver disease (hepatic encephalopathy).

8.

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?

1.

Store zolpidem tartrate extended-release tablets at room temperature between 68°F to 77°F (20°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.

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

Repackaged By: Preferred Pharmaceuticals Inc.