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Medication Guide

AMBIEN CR®
(am'be-an see ahr)
( zolpidem tartrate extended-release tablets)

Read the Medication Guide that comes with AMBIEN CR (zolpidem tartrate) 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 doctor about your medical condition or treatment.

What is the most important information I should know about AMBIEN CR (zolpidem tartrate) ?

After taking AMBIEN CR (zolpidem tartrate) , 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. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with AMBIEN CR (zolpidem tartrate) . Reported activities include:

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

Call your doctor right away if you find out that you have done any of the above activities after taking AMBIEN CR (zolpidem tartrate) .

Important:

1. Take AMBIEN CR (zolpidem tartrate) exactly as prescribed
   • Do not take more AMBIEN CR (zolpidem tartrate) than prescribed.
   • Take AMBIEN CR (zolpidem tartrate) right before you get in bed, not sooner.
2. Do not take AMBIEN CR (zolpidem tartrate) if you:
   • drink alcohol
   • take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take AMBIEN CR (zolpidem tartrate) with your other medicines.
   • cannot get a full night's sleep

What is AMBIEN CR (zolpidem tartrate) ?

AMBIEN CR (zolpidem tartrate) is a sedative-hypnotic (sleep) medicine. AMBIEN CR (zolpidem tartrate) is 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

AMBIEN CR (zolpidem tartrate) is not for children.

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

Who should not take AMBIEN CR (zolpidem tartrate) ?

Do not take AMBIEN CR (zolpidem tartrate) if you are allergic to anything in it. See the end of this Medication Guide for a complete list of ingredients in AMBIEN CR (zolpidem tartrate) .

AMBIEN CR (zolpidem tartrate) may not be right for you. Before starting AMBIEN CR (zolpidem tartrate) , tell your doctor 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, or breastfeeding

Tell your doctor 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 (zolpidem tartrate) with other medicines that can make you sleepy.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

How should I take AMBIEN CR (zolpidem tartrate) ?

• Take AMBIEN CR (zolpidem tartrate) exactly as prescribed. Do not take more AMBIEN CR (zolpidem tartrate) than prescribed for you.
• Take AMBIEN CR (zolpidem tartrate) right before you get into bed.
• Do not take AMBIEN CR (zolpidem tartrate) unless you are able to stay in bed a full night (7-8 hours) before you must be active again.
• Swallow AMBIEN CR (zolpidem tartrate) Tablets whole. Do not chew or break the tablets. Tell your doctor if you cannot swallow tablets whole.
• For faster sleep onset, AMBIEN CR (zolpidem tartrate) should NOT be taken with or immediately after a meal.
• Call your doctor 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 AMBIEN CR (zolpidem tartrate) or overdose, call your doctor or poison control center right away, or get emergency treatment.

What are the possible side effects of AMBIEN CR (zolpidem tartrate) ?

Serious side effects of AMBIEN CR (zolpidem tartrate) include:

• getting out of bed while not being fully awake and do an activity that you do not know you are doing. (See “What is the most important information I should know about AMBIEN CR (zolpidem tartrate) ?)
• 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 AMBIEN CR (zolpidem tartrate) .

Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using AMBIEN CR (zolpidem tartrate) .

The most common side effects of AMBIEN CR (zolpidem tartrate) are:

• headache
• sleepiness
• dizziness
• You may still feel drowsy the next day after taking AMBIEN CR (zolpidem tartrate) . Do not drive or do other dangerous activities after taking AMBIEN CR (zolpidem tartrate) until you feel fully awake.

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, and stomach area pain.

These are not all the side effects of AMBIEN CR (zolpidem tartrate) . Ask your doctor or pharmacist for more information.

How should I store AMBIEN CR (zolpidem tartrate) ?

• Store AMBIEN CR (zolpidem tartrate) at room temperature, 59° to 77°F (15° to 25° C).
• Keep AMBIEN CR (zolpidem tartrate) and all medicines out of reach of children.

General Information about AMBIEN CR (zolpidem tartrate)

• Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
• Do not use AMBIEN CR (zolpidem tartrate) for a condition for which it was not prescribed.
• Do not share AMBIEN CR (zolpidem tartrate) 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 AMBIEN CR (zolpidem tartrate) . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about AMBIEN CR (zolpidem tartrate) that is written for healthcare professionals. For more information about AMBIEN CR (zolpidem tartrate) , call 1-800-633-1610 or visit www.ambiencr.com.

What are the ingredients in AMBIEN CR?

Active Ingredient: Zolpidem tartrate

Inactive Ingredients: 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.

Last reviewed on RxList: 5/10/2010
This monograph has been modified to include the generic and brand name in many instances.