WHAT IS AMBIEN® (ZOLPIDEM TARTRATE) OR AMBIEN CR® (ZOLPIDEM TARTRATE)

AMBIEN is a prescription medicine for the short-term treatment of adults who have trouble falling asleep.

AMBIEN CR is a prescription medicine for treatment of adults with trouble falling asleep and/or waking up often during the night.

AMBIEN and AMBIEN CR are not recommended in children under the age of 18 years.

IMPORTANT SAFETY INFORMATION

WARNING: COMPLEX SLEEP BEHAVIORS Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of AMBIEN or AMBIEN CR. Some of these events may result in serious injuries, including death. Discontinue AMBIEN or AMBIEN CR immediately if you experience a complex sleep behavior.

Do not take more AMBIEN or AMBIEN CR than prescribed.

Do not take AMBIEN or AMBIEN CR unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again.

Take AMBIEN or AMBIEN CR only once per night, right before going to bed.

AMBIEN and AMBIEN CR may cause serious side effects including complex sleep behaviors that have caused serious injury and death. After taking AMBIEN or AMBIEN CR you may get up out of bed while not being fully awake and do an activity that you do not know you are doing (complex sleep behaviors). The next morning, you may not remember that you did anything during the night. These activities may occur with AMBIEN or AMBIEN CR whether or not you drink alcohol or take other medicines that make you sleepy.

• Reported activities include:
  • driving a car ("sleep-driving")
  • making and eating food
  • talking on the phone
  • having sex
  • sleep-walking
• Stop taking AMBIEN or AMBIEN CR and call your doctor right away if you find out that you have done any of these activities after taking AMBIEN or AMBIEN CR.

You should not drive a car or do things that require clear thinking the day after you take AMBIEN CR.

Do not take AMBIEN or AMBIEN CR if you:

• have ever experienced a complex sleep behavior (such as driving a car, making and eating food, talking on the phone, or having sex while not being fully awake) after taking AMBIEN or AMBIEN CR.
• drank alcohol that evening or before bed.
• take other medicines that can make you sleepy.

AMBIEN and AMBIEN CR are federally controlled substances (C-IV) because they can be abused or cause dependence.

Do not take AMBIEN or AMBIEN CR if you are allergic to zolpidem or any other ingredients in AMBIEN or AMBIEN CR.

• Do not take AMBIEN or AMBIEN CR if you have had an allergic reaction to drugs containing zolpidem, such as AMBIEN CR, Edluar, Zolpimist, or Intermezzo.
• Symptoms of a serious allergic reaction to zolpidem can include swelling of your face, lips, and throat that may cause difficulty breathing or swallowing

Before taking AMBIEN or AMBIEN CR, tell your doctor about all of your medical 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 or plan to become pregnant
• are breastfeeding or plan to breastfeed.

AMBIEN and AMBIEN CR may cause serious side effects, including:

• getting out of bed while not being fully awake and doing an activity that you do not know you are doing.
• abnormal thoughts and behavior. For AMBIEN and AMBIEN CR, symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions and additionally for AMBIEN CR, acting strangely.
• memory loss
• anxiety
• severe allergic reactions. Symptoms include swelling of the tongue or throat, and trouble breathing. Get emergency medical help if you get these symptoms after taking AMBIEN or AMBIEN CR.
• Call your healthcare provider right away if you have any of the above side effects or any other side effects that worry you while using AMBIEN or AMBIEN CR.

The most common side effects of AMBIEN include drowsiness, dizziness, diarrhea, grogginess or feeling as if you have been drugged.

The most common side effects of AMBIEN CR include headache, sleepiness, dizziness and drowsiness the next day after you take AMBIEN CR.

Take AMBIEN CR tablets whole. Do not break, crush, dissolve or chew AMBIEN CR tablets before swallowing.

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.

AMBIEN is a prescription medicine for the short-term treatment of adults who have trouble falling asleep.
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