MEDICATION GUIDE
AMBIEN® (âm’bé-on) Tablets C-IV
(zolpidem tartrate)
Read the Medication Guide that comes with AMBIEN 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?
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 medicines that make you sleepy with
AMBIEN. 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.
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 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 with your other medicines.
•
cannot get a full night’s sleep
What is AMBIEN?
AMBIEN is a sedative-hypnotic (sleep) medicine. AMBIEN is used in
adults for the short-term treatment of a sleep problem called insomnia.
Symptoms of insomnia 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 AMBILN may harm others,
and is against the law. fell 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 complete 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, 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 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?
• Take AMBIEN exactly as prescribed. Do not take more 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
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 problem.
•
If you take too much AMBIEN or overdose, call your doctor or poison
control center right away, or get emergency treatment.
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 important information I should know about AMBIEN?)
• abnormal thoughts and behavior. Symptoms include more outgoing
or aggressive behavior than normal, confusion, agitation, hallucina-
tions, worsening of depression, and suicidal thoughts or actions.
•
memory loss
•
anxiety
• severe allergic reactions. Symptoms include swelling of the tongue
or tfiroat, trouble breathing, and nausea and vomiting. Get emer-
gency medical help if you get these symptoms after taking AMBILN.
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 may still feel drowsy the next day after taking AMBIEN. 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 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. 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 1-80G-FDA-1088.
How should I store AMBIEN?
•
Store AMBIEN at room temperature, 68° to 77°F (20° to 25°C).
•
Keep AMBIEN and all medicines out of reach of children.
General Information about AMBIEN
•
Medicines are sometimes prescribed for purposes other than those
listed in a Medication Guide.
•
Do not use AMBIEN for a condition for which it was not prescribed.
•
Do not share AMBIEN 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 AMBILN. If you would like more information, talk with your
doctor. You can ask your doctor or pharmacist for information about
AMBIEN that is written for healthcare professionals. For more informa-
tion about AMBIEN, call 1-800-633-1610.
What are the ingredients in AMBIEN?
Active Ingredient: Zolpidem tartrate
Inactive Ingredients: hydroxypropyl methylcellulose, lactose, magne-
sium stearate, micro-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
Administration.
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
June 2008
A M B - |U N E 0 8 - M - A a
