Side Effects of AMBIEN CR and Other
Sleep Aid Medications

Learn the most common side effects of sleep aid medicines and understand the special concerns regarding your sleep medicine.

As with any medication, use AMBIEN CR as prescribed by your doctor. If you have any questions about AMBIEN CR, and/or think you may be suffering from any of the side effects below, be sure to talk to your healthcare provider or pharmacist.

Common Side Effects

All medicines have side effects. Sleep medicines may cause next day drowsiness, dizziness, headaches, lightheadedness, and difficulty with coordination.

In controlled clinical trials of AMBIEN CR, the most commonly observed adverse effects were headache, somnolence (sleepiness), and dizziness.

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. Your doctor will work with you to find the dose of AMBIEN CR that is best for you.

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

• When you first start taking AMBIEN CR 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 CR or any sleep medicine. Alcohol can increase the side effects of AMBIEN CR 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 CR.
• Always take the exact dose of AMBIEN CR prescribed by your doctor. Never change your dose without talking to your doctor first. Make sure that you swallow the tablet whole and do not divide it, crush it or chew it.
• In two clinical studies of patients with insomnia, a rebound effect (worsening of insomnia) was only observed on the first night after an abrupt discontinuation of AMBIEN CR. On the second night, there was no worsening of insomnia.

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Special Concerns

Be aware, sleep medication may cause memory problems, tolerance, dependence, withdrawal, and changes in behavior and thinking.

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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." Be sure to talk to your doctor if you think you are having memory problems.

Although memory problems are not very common while taking AMBIEN CR, in most instances, they can be avoided if you take AMBIEN CR only when you are able to get a full night's sleep (7 to 8 hours) before you need to be active again.

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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 one or two days and generally no longer than one or two weeks. If your sleep problems continue, consult your doctor, who will determine whether other measures are needed to overcome your sleep problems.

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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 may occur (see withdrawal section). They may find that they have to keep taking the medicines 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 CR or any sleep medicine.

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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 one or two nights.

If you have been taking AMBIEN CR or any other sleep medicine for more than one or two weeks, do not stop taking it on your own. Always follow your doctor's directions.

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Changes in Behavior and Thinking

Some people using sleep medicines have experienced unusual changes in their thinking and/or behavior. These side effects are not common. However, they have included:

• more outgoing or aggressive behavior than normal
• confusion
• strange behavior
• agitation
• hallucinations
• worsening of depression
• suicidal thoughts

How often these side 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.

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.

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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 CR.

If you are concerned about the risks of side effects associated with Ambien CR and other sleep aid medications, talk to your healthcare provider.

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