M EDICATION GUIDE
AM BIEN CR* (am’be-on see ahr) C-IV
(zolpiclem tartrate extended-release tablets)
Read the Medication Guide that comes with AMBIEN CR before you
start taking it and each tim e you get a refill. There m ay be new infor-
m ation. This Medication Guide does not take the place of talking to
your doctor about your medical condition or treatm ent.
W hat is the m ost im p o rtan t in fo rm atio n I should kno w about
AM BIEN CR?______________________________________________________
A fter takin g AM BIEN CR, you m ay get up out o f bed w h ile not being
fu lly aw ake and do an activity that you do not know you are doing.
Th e next m orning , you m ay not rem em b er th a t you did anything
during the night. You have a higher chance for doing these activities if
you drink alcohol or take other m edicines that m ake you sleepy with
AMBIEN CR. Reported activities include:
•
driving a car (“sleep-driving”)
•
m aking and eating food
•
talking on the phone
•
having sex
•
sleep-walking_____________________________________________________
Call yo u r doctor right aw ay if you fin d out th a t you have done any
of the above activitie s afte r takin g AM BIEN CR.
Im p o rtan t:
1. Take AM BIEN 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 AM BIEN CR if you:
•
drink alcohol
•
take other m edicines that can m ake you sleepy. Talk to your doctor
about all of your m edicines. Your doctor w ill tell you if you can take
AMBIEN CR with your other medicines.
•
cannot get a full night’s sleep
W hat is AM BIEN CR?
AMBIEN CR is a sedative-hypnotic (sleep) m edicine. AMBIEN CR is used in
adults for the treatm ent of a sleep problem called insom nia. Symptoms
of insom nia include:
•
trouble falling asleep
•
waking up often during the night
AMBIEN 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.
W ho should not take AM BIEN 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.
AM BIEN CR m ay not be right fo r you. Before starting AM BIEN CR, tell
yo ur doctor about all of yo ur health cond itions, includ ing if you:
•
have a history of depression, m ental 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 m edicines you take including prescrip-
tion and nonprescription m edicines, vitam ins and herbal supplem ents.
Medicines can interact with each other, som etim es causing serious side
effects. Do not take AM BIEN CR w ith oth er m ed icines that can m ake
you sleepy.
Know the m edicines you take. Keep a list of your m edicines with you to
show your doctor and pharm acist each tim e you get a new m edicine.
How should I take AM BIEN CR?
•
Take AMBIEN CR exactly as prescribed. Do not take more AMBIEN CR
than prescribed for you.
•
Take AM BIEN CR right before you get into bed.
•
Do not take AM BIEN CR unless you are ab le to stay in bed a fu ll
night (7-8 hours) before you m ust be active ag ain .
•
Swallow AMBIEN CR Tablets 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 betaken with or im m e-
diately after a m eal.
•
Call your doctor if your insom nia worsens or is not better w ithin 7 to
10 days. This m ay mean that there is another condition causing your
sleep problems.
•
If you take too m uch AMBIEN CR or overdose, call your doctor or
poison control center right away, or get emergency treatm ent.
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 im portant inform ation I should know about AMBIEN CR?)
•
abnormal thoughts and behavior.
Symptoms include m ore out-
going or aggressive behavior than norm al, 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 m ay still feel drowsy the next day after taking AMBIEN 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 sym ptom s for
1 to 2 days such as: trouble sleeping, nausea, flushing, lightheaded ness,
uncontrolled crying, vom iting, stomach cram ps, panic attack, nervous-
ness, and stomach area pain.
These are not all the side effects of AMBIEN CR. Ask your doctor or
pharm acist for more inform ation.
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 tem perature, 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 som etim es 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 sam e sym ptom s that you have. It m ay harm them and it is
against the law.
This Medication Guide sum m arizes the most important information
about AMBIEN CR. If you would like more inform ation, talk with your
doctor. You can ask your doctor or pharm acist for information about
AMBIEN CR that is written for healthcare professionals. For more inform a-
tion about AMBIEN CR, call 1-800-633-1610 or visit www.am biencr.com .
What are the ingredients in AMBIEN CR?
Active Ingredient:
Zolpidem tartrate
Inactive Ingredients:
The 6.25 mg tablets contain: colloidal silicon
dioxide,
hyprom ellose,
lactose
m onohydrate,
m agnesium
stearate,
m icrocrystalline 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 m onohydrate, magnesium stearate, m icrocrystalline 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
Adm inistration.
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
January 2008a
AMBCR-JAN08a-M-A
