INFORMATION FOR PATIENTS TAKING AMBIEN

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ZPSS-5A

Ambien®

(zolpidem tartrate)

INFORMATION FOR PATIENTS TAKING AMBIEN

Your doctor has prescribed Ambien to help you sleep. The following information

is intended to guide you in the safe use of this medicine. It is not meant to

take the place of your doctor's instructions. If you have any questions about

Ambien tablets be sure to ask your doctor or pharmacist.

Ambien is used to treat different types of sleep problems, such as:

.. trouble falling asleep

.. waking up too early in the morning

.. waking up often during the night

Some people may have more than one of these problems.

Ambien belongs to a group of medicines known as the " sedative/hypnotics, " or

simply, sleep medicines. There are many different sleep medicines available to

help people sleep better. Sleep problems are usually temporary, requiring

treatment for only a short time, usually 1 or 2 days up to 1 or 2 weeks. Some

people have chronic sleep problems that may require more prolonged use of sleep

medicine. However, you should not use these medicines for long periods without

talking with your doctor about the risks and benefits of prolonged use.

SIDE EFFECTS

Most common side effects: All medicines have side effects. Most common side

effects of sleep medicines include:

.. drowsiness

.. dizziness

.. lightheadedness

.. difficulty with coordination

You may find that these medicines make you sleepy during the day. How drowsy you

feel depends upon how your body reacts to the medicine, which sleep medicine you

are taking, and how large a dose your doctor has prescribed. Daytime drowsiness

is best avoided by taking the lowest dose possible that will still help you

sleep at night. Your doctor will work with you to find the dose of Ambien that

is best for you.

To manage these side effects while you are taking this medicine:

.. When you first start taking Ambien or any other sleep medicine until you know

whether the medicine will still have some carryover effect in you the next day,

use extreme care while doing anything that requires complete alertness, such as

driving a car, operating machinery, or piloting an aircraft.

.. NEVER drink alcohol while you are being treated with Ambien or any sleep

medicine. Alcohol can increase the side effects of Ambien or any other sleep

medicine.

.. Do not take any other medicines without asking your doctor first. This

includes medicines you can buy without a prescription. Some medicines can cause

drowsiness and are best avoided while taking Ambien.

.. Always take the exact dose of Ambien prescribed by your doctor. Never change

your dose without talking to your doctor first.

SPECIAL CONCERNS

There are some special problems that may occur while taking sleep medicines.

Memory problems: Sleep medicines may cause a special type of memory loss or

" amnesia. " When this occurs, a person may not remember what has happened for

several hours after taking the medicine. This is usually not a problem since

most people fall asleep after taking the medicine.

Memory loss can be a problem, however, when sleep medicines are taken while

traveling, such as during an airplane flight and the person wakes up before the

effect of the medicine is gone. This has been called " traveler's amnesia. "

Memory problems are not common while taking Ambien. In most instances memory

problems can be avoided if you take Ambien only when you are able to get a full

night's sleep (7 to 8 hours) before you need to be active again. Be sure to talk

to your doctor if you think you are having memory problems.

Tolerance: When sleep medicines are used every night for more than a few weeks,

they may lose their effectiveness to help you sleep. This is known as

" tolerance.'' Sleep medicines should, in most cases, be used only for short

periods of time, such as 1 or 2 days and generally no longer than 1 or 2 weeks.

If your sleep problems continue, consult your doctor, who will determine whether

other measures are needed to overcome your sleep problems.

Dependence: Sleep medicines can cause dependence, especially when these

medicines are used regularly for longer than a few weeks or at high doses. Some

people develop a need to continue taking their medicines. This is known as

dependence or " addiction. "

When people develop dependence, they may have difficulty stopping the sleep

medicine. If the medicine is suddenly stopped, the body is not able to function

normally and unpleasant symptoms (see Withdrawal) may occur. They may find they

have to keep taking the medicine either at the prescribed dose or at increasing

doses just to avoid withdrawal symptoms.

All people taking sleep medicines have some risk of becoming dependent on the

medicine. However, people who have been dependent on alcohol or other drugs in

the past may have a higher chance of becoming addicted to sleep medicines. This

possibility must be considered before using these medicines for more than a few

weeks.

If you have been addicted to alcohol or drugs in the past, it is important to

tell your doctor before starting Ambien or any sleep medicine.

Withdrawal: Withdrawal symptoms may occur when sleep medicines are stopped

suddenly after being used daily for a long time. In some cases, these symptoms

can occur even if the medicine has been used for only a week or two.

In mild cases, withdrawal symptoms may include unpleasant feelings. In more

severe cases, abdominal and muscle cramps, vomiting, sweating, shakiness, and

rarely, seizures may occur. These more severe withdrawal symptoms are very

uncommon.

Another problem that may occur when sleep medicines are stopped is known as

" rebound insomnia. " This means that a person may have more trouble sleeping the

first few nights after the medicine is stopped than before starting the

medicine. If you should experience rebound insomnia, do not get discouraged.

This problem usually goes away on its own after 1 or 2 nights.

If you have been taking Ambien or any other sleep medicine for more than 1 or 2

weeks, do not stop taking it on your own. Always follow your doctor's

directions.

Changes in behavior and thinking: Some people using sleep medicines have

experienced unusual changes in their thinking and/or behavior. These effects are

not common. However, they have included:

.. more outgoing or aggressive behavior than normal

.. loss of personal identity

.. confusion

.. strange behavior

.. agitation

.. hallucinations

.. worsening of depression

.. suicidal thoughts

How often these effects occur depends on several factors, such as a person's

general health, the use of other medicines, and which sleep medicine is being

used. Clinical experience with Ambien suggests that it is uncommonly associated

with these behavior changes.

It is also important to realize that it is rarely clear whether these behavior

changes are caused by the medicine, an illness, or occur on their own. In fact,

sleep problems that do not improve may be due to illnesses that were present

before the medicine was used. If you or your family notice any changes in your

behavior, or if you have any unusual or disturbing thoughts, call your doctor

immediately.

Pregnancy: Sleep medicines may cause sedation of the unborn baby when used

during the last weeks of pregnancy.

Be sure to tell your doctor if you are pregnant, if you are planning to become

pregnant, or if you become pregnant while taking Ambien.

SAFE USE OF SLEEPING MEDICINES

To ensure the safe and effective use of Ambien or any other sleep medicine, you

should observe the following cautions:

1. Ambien is a prescription medicine and should be used ONLY as directed by your

doctor. Follow your doctor's instructions about how to take, when to take, and

how long to take Ambien.

2. Never use Ambien or any other sleep medicine for longer than directed by your

doctor.

3. If you notice any unusual and/or disturbing thoughts or behavior during

treatment with Ambien or any other sleep medicine, contact your doctor.

4. Tell your doctor about any medicines you may be taking, including medicines

you may buy without a prescription. You should also tell your doctor if you

drink alcohol. DO NOT use alcohol while taking Ambien or any other sleep

medicine.

5. Do not take Ambien unless you are able to get a full night's sleep before you

must be active again. For example, Ambien should not be taken on an overnight

airplane flight of less than 7 to 8 hours since " traveler's amnesia " may occur.

6. Do not increase the prescribed dose of Ambien or any other sleep medicine

unless instructed by your doctor.

7. When you first start taking Ambien or any other sleep medicine until you know

whether the medicine will still have some carryover effect in you the next day,

use extreme care while doing anything that requires complete alertness, such as

driving a car, operating machinery, or piloting an aircraft.

8. Be aware that you may have more sleeping problems the first night or two

after stopping Ambien or any other sleep medicine.

9. Be sure to tell your doctor if you are pregnant, if you are planning to

become pregnant, or if you become pregnant while taking Ambien.

10. As with all prescription medicines, never share Ambien or any other sleep

medicine with anyone else. Always store Ambien or any other sleep medicine in

the original container out of reach of children.

11. Ambien works very quickly. You should only take Ambien right before going to

bed and are ready to go to sleep.

Distributed by:

Sanofi-Synthelabo Inc.

New York, NY 10016

Printed in USA

Revised June 2002

Copyright Sanofi-Synthelabo Inc. 2001, 2002