MEDICATION GUIDE
AMBIEN®
(âm’bé-an)
Tablets C-IV
[zolpidem tartrate)
Read the Medication Guide that comes with AMBIEN before you start
taking it and each tim e you get a refill. There m ay be new inform ation.
This Medication Guide does not take the place of talking to your doctor
about your m edical condition or treatm ent.__________________________
What is the most important information
I should
know about
AMBIEN?
After taking AMBIEN, 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 m edicines that m ake you sleepy with
AM BIEN. Reported activities include:
•
driving a car (“sleep-driving”)
•
m aking 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.
Important:
1. Take AMBIEN exactly as prescribed
•
Do not take more AMBIEN than prescribed.
•
Take AMBIEN right before you get in bed, not sooner.
2. Do not take AMBIEN 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 with your other m edicines.
•
cannot get a full night’s sleep_____________________________________
What is AMBIEN?
AMBIEN is a sedative-hypnotic (sleep) m edicine. AMBIEN is used in
adults for the short-term treatm ent of a sleep problem called insom nia.
Sym ptom s of insom nia include:
•
trouble falling asleep
AMBIEN is not for children.
AMBIEN is a federally controlled substance (C-IV) because it can be
abused or lead to dependence. Keep AMBIEN in a safe place to prevent
misuse and abuse. Selling or giving away AMBIEN 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?
Do not take AMBIEN if you are allergic to anything in it.
See the end of this Medication Guide for a com plete list of ingredients
in AMBIEN.
AMBIEN may not be right for you. Before starting AMBIEN, tell
your doctor about all of your health conditions, including 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 AMBIEN with other medicines that can make
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 AMBIEN?
•
Take AMBIEN exactly as prescribed. Do not take m ore AMBIEN than
prescribed for you.
•
Take AMBIEN right before you get into bed.
•
Do not take AMBIEN unless you are able to stay in bed a full
night (7-8 hours) before you must be active again.
•
For
faster sleep
onset,
AMBIEN
should
NOT
be
taken
with
or
im m ediately 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 m ean that there is another condition causing your
sleep problem .
•
If you take too m uch AMBIEN or overdose, call your doctor or poison
control center right away, or get em ergency treatm ent.
What are the possible side effects of AMBIEN?
Serious side effects of AMBIEN 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?)
•
abnormal thoughts and behavior.
Symptoms include more outgoing
or aggressive behavior than norm al, confusion, agitation, hallucina-
tions, worsening of depression, and suicidal thoughts or actions.
•
memory loss
•
anxiety
•
severe allergic reactions.
Sym ptom s include swelling of the tongue
or throat, trouble breathing, and nausea and vom iting. Get em er-
gency m edical help if you get these sym ptom s after taking AMBIEN.
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.
The most common side effects of AMBIEN are:
•
drowsiness
•
dizziness
•
diarrhea
•
“drugged feelings”
•
You m ay still feel drowsy the next day after taking AM BIEN.
Do not
drive or do other dangerous activities after taking AMBIEN 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, lightheadedness,
uncontrolled crying, vom iting, stom ach cram ps, panic attack, nervous-
ness, and stom ach area pain.
These are not all
the side effects of AM BIEN. Ask your doctor or
pharm acist for m ore inform ation.
Call your doctor for m edical advice about side effects. You m ay report
side effects to FDA at 1-80Q-FDA—1088.
How should I store AMBIEN?
•
Store AMBIEN at room tem perature, 68° to 77°F (20° to 25°C).
•
Keep AMBIEN and all medicines out of reach of children.
General Information about AMBIEN
•
M edicines are som etim es prescribed for purposes other than those
listed in a Medication Guide.
•
Do not use AMBIEN for a condition for w hich it was not prescribed.
•
Do not share AMBIEN 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 im portant inform ation
about AM BIEN. If you would like m ore inform ation, talk with your
doctor. You can ask your doctor or pharm acist for inform ation about
AMBIEN that is written for healthcare professionals. For m ore inform a-
tion about AM BIEN, call 1-800-633-1610.
What are the ingredients in AMBIEN?
Active Ingredient:
Zolpidem tartrate
Inactive Ingredients:
hydroxypropyl m ethylcellulose, lactose, m agne-
sium stearate, m icro-crystalline cellulose, polyethylene glycol, sodium
starch glycolate, and titanium dioxide. In addition, the 5 mg tablet
contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80.
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
June 2008 AMB-JUNE08-M-Aa
