AMBIEN CR- zolpidem tartrate tablet, coated
PD-Rx Pharmaceuticals, Inc.
ām'bē-ən see ahr
(zolpidem tartrate) extended-release tablets C-IV
Read the Medication Guide that comes with AMBIEN CR 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.
AMBIEN CR may cause serious side effects including complex sleep behaviors that have caused serious injury and death. After taking AMBIEN CR, 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 AMBIEN CR whether or not you drink alcohol or take other medicines that make you sleepy. Reported activities include:
Stop taking AMBIEN CR and call your healthcare provider right away if you find out that you have done any of the above activities after taking AMBIEN CR.
You should not drive a car or do things that require clear thinking the day after you take AMBIEN CR.
Do not take AMBIEN CR if you:
What is AMBIEN CR?
AMBIEN CR is a sedative-hypnotic (sleep) medicine. AMBIEN CR is used in adults for the treatment of a sleep problem called insomnia. Symptoms of insomnia include:
AMBIEN CR is not recommended for use in children under the age of 18 years.
|AMBIEN CR is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep AMBIEN CR in a safe place to prevent misuse and abuse. Selling or giving away AMBIEN CR 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 AMBIEN CR?
What should I tell my healthcare provider before taking AMBIEN CR?
AMBIEN CR may not be right for you. Before starting AMBIEN CR, tell your healthcare provider about all of your health conditions, including if you:
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 AMBIEN CR 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 AMBIEN CR?
What are the possible side effects of AMBIEN CR?
AMBIEN CR may cause serious side effects including:
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 AMBIEN CR.
The most common side effects of AMBIEN CR are:
After you stop taking a sleep medicine, you may have symptoms for 1 to 2 days such as:
These are not all the side effects of AMBIEN CR. Ask your healthcare provider or pharmacist for more information.
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 AMBIEN CR?
Store AMBIEN CR at room temperature, 59°F to 77°F (15°C to 25°C).
Keep AMBIEN CR and all medicines out of reach of children.
General Information about the safe and effective use of AMBIEN CR
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AMBIEN CR for a condition for which it was not prescribed. Do not share AMBIEN CR with other people, even if 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 AMBIEN CR. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about AMBIEN CR that is written for healthcare professionals.
For more information, go to www.ambiencr.com or call 1-800-633-1610.
What are the ingredients in AMBIEN CR?
Active Ingredient: Zolpidem tartrate
The 6.25 mg tablets contain: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, red ferric oxide, sodium starch glycolate, and titanium dioxide.
The 12.5 mg tablets contain: colloidal silicon dioxide, FD&C Blue #2, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, sodium starch glycolate, titanium dioxide, and yellow ferric oxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
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Bridgewater, NJ 08807
A SANOFI COMPANY
Revised: August 2019
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