Ambien

Patient Information

font size

PATIENT INFORMATION

Patient counseling Information

General

Patient information is printed at the end of this insert. To assure safe and effective use of Ambien, this information and instructions provided in the patient information section should be discussed with patients.

FDA-approved patient labeling

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 in adults, 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.

“Sleep-Driving” and other complex behaviors

There have been reports of people getting out of bed after taking a sleep medicine and driving their cars while not fully awake, often with no memory of the event. If you experience such an event, it should be reported to your doctor immediately, since “sleep-driving” can be dangerous. This behavior is more likely to occur when Ambien is taken with alcohol or other drugs such as those for the treatment of depression or anxiety. Other behaviors such as preparing and eating food, making phone calls, or having sex have been reported in people who are not fully awake after taking a sleep medicine. As with “sleep-driving”, people usually do not remember these events.

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 &rdquo 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.

Children

Ambien has not been shown to help children fall asleep. Hallucinations, headache and dizziness have all been reported as side effects in children who were given 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:

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.
Never use Ambien or any other sleep medicine for longer than directed by your doctor.
If you develop an allergic reaction such as a rash, hives, shortness of breath, or swelling of your tongue or throat when using Ambien or any other sleep medicine, discontinue Ambien or other sleep medicine immediately and contact your doctor.
If you notice any unusual and/or disturbing thoughts or behavior during treatment with Ambien or any other sleep medicine, contact your doctor.
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.
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.
Do not increase the prescribed dose of Ambien or any other sleep medicine unless instructed by your doctor.
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.
Be aware that you may have more sleeping problems the first night or two after stopping Ambien or any other sleep medicine.
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.
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.
Ambien works very quickly. You should only take Ambien right before going to bed and are ready to go to sleep.