MEDICATION GUIDE
AMBIEN CR* (am’be-dn see ahr) C-IV
(zolpidem ta rtra te extended-release tablets)
Read the Medication Guide that comes with AMBILN CR before you
start taking it and each time you get a refill. There may be new infor-
mation. 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?
________________________________________
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.
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. 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.
Important:
1. Take AMBIEN CR exactly as prescribed
•
Do not take more AMBIEN CR than prescribed.
• Take AMBIEN CR right before you get in bed, not sooner.
2. Do not take AMBIEN CR 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 with your other medicines.
•
cannot get a full night’s sleep
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:
•
trouble falling asleep
•
waking up often during the night
AMBILN CR is not for children.
_____________________________
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 pre-
vent misuse and abuse. Selling or giving away AMBIEN CR may harm oth-
ers, 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?
Do not take AMBIEN CR if you are allergic to anything in it. See the end
of this Medication Guide for a complete list of ingredients in AMBIEN CR.
AMBIEN CR may not be right for you. Before starting AMBIEN CR, 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 prescrip-
tion 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.
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?
•
Take AMBIEN CR exactly as prescribed. Do not take more AMBIEN CR
than prescribed for you.
• Take AMBIEN CR right before you get into bed.
•
Do not take AMBIEN CR unless you are able to stay in bed a full
night (7-8 hours) before you must be active again.
•
Swallow AMBILN CR lablets whole. Do not chew or break the tablets.
Tell your doctor if you cannot swallow tablets whole.
•
For faster sleep onset, AMBIEN CR should NOT be taken with or imme-
diately 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 or overdose, call your doctor or
poison control center right away, or get emergency treatment.
What are the possible side effects of AMBIEN CR?
Serious side effects of AMBIEN CR 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 AMBIFN CR?)
•
abnormal thoughts and behavior. Symptoms include more out-
going or aggressive behavior than normal, confusion, agitation, hallu-
cinations, 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.
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.
The most common side effects of AMBIEN CR are:
•
headache
• sleepiness
•
dizziness
• You may still feel drowsy the next day after taking AMBIFN CR. Do not
drive or do other dangerous activities after taking AMBIEN CR
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, nervous-
ness, and stomach area pain.
These are not all the side effects of AMBIEN CR. Ask your doctor or
pharmacist for more information.
Call your doctor for medical advice about side effects. You may report
side effects to FDA at 1 —80Q-FDA—1088.
How should I store AMBIEN CR?
•
Store AMBIEN CR at room temperature, 59° to 77°F (15° to 25° C).
•
Keep AMBIEN CR and all medicines out of reach of children.
General Information about 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 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. If you would like more information, talk with your
doctor. You can ask your doctor or pharmacist for information about
AMBIEN CR that is written for healthcare professionals. For more informa-
tion about AMBIEN CR, 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, polyethyleneglycol, 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.
Rx Only
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
lanuary 2008a
AMBCR-JAN08a-M-A
