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AMBIEN CR (Zolpidem Tartrate Extended Release) Sleep Aid
 
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AMBIEN CR Side Effects

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All medicines have side effects.

When taking a medication such as AMBIEN CR, you want the benefits to outweigh the risks. AMBIEN CR has been shown to have low abuse potential in clinical studies.

However, as with any medication, it is important that you use AMBIEN CR as prescribed. 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
In controlled clinical trials of AMBIEN CR, the most commonly observed adverse effects were headache, somnolence, and dizziness.

To manage these side effects while you are taking this medicine keep the following things in mind:

  • 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 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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Other concerns
You should be aware that sleep medication may cause memory problems, tolerance, dependence, withdrawal, changes in behavior and thinking, and issues concerning pregnancy.

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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 used regularly for longer than a few weeks or at high doses. Some people develop a need to continue taking their sleep medication. 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 face 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 greater chance of becoming addicted to sleep medicines.

This possibility must be considered before using any kind of sleep medicine. 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 sleep 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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AMBIEN CR is indicated to help you fall asleep and/or stay asleep.

IMPORTANT SAFETY INFORMATION

AMBIEN CR is a treatment option you and your healthcare provider can consider along with lifestyle changes and can be taken for as long as your provider recommends. Until you know how AMBIEN CR will affect you, you shouldn't drive or operate machinery. Be sure you're able to devote 7 to 8 hours to sleep before being active again. Sleepwalking, and eating or driving while not fully awake, with amnesia for the event, have been reported. If you experience any of these behaviors contact your provider immediately. In rare cases, sleep medicines may cause allergic reactions such as swelling of your tongue or throat, shortness of breath or more severe results. If you have an allergic reaction while using AMBIEN CR, contact your doctor immediately. Side effects may include next-day drowsiness, dizziness, and headache. It's non-narcotic; however, like most sleep medicines, it has some risk of dependency. Don't take it with alcohol.

Please refer to the full prescribing information and medication guide.

AMBIEN is indicated for short-term treatment, to help you fall asleep.

IMPORTANT SAFETY INFORMATION

When you first start taking AMBIEN, use caution in the morning when engaging in activities requiring complete alertness until you know how you will react to this medication. 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. As with any sleep medication, do not use alcohol while you are taking AMBIEN.

Sleepwalking, and eating or driving while not fully awake, with amnesia for the event, have been reported. If you experience any of these behaviors contact your provider immediately. In rare cases, sleep medicines may cause allergic reactions such as swelling of your tongue or throat, shortness of breath or more severe results. If you have an allergic reaction while using AMBIEN, contact your doctor immediately.

Prescription sleep aids are often taken for 7 to 10 days – or longer as advised by your provider. Like most sleep medicines, it has some risk of dependency.

There is a low occurrence of side effects associated with the short-term use of AMBIEN. The most commonly observed side effects in controlled clinical trials were drowsiness (2%), dizziness (1%), and diarrhea (1%).

Please refer to the full prescribing information and medication guide.


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