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AMBIEN- zolpidem tartrate tablet, film coated


  1. Patient Information
  2. Important:
  3. 2. Do Not Take Ambien If You:
  4. What Is Ambien?
  5. Who Should Not Take Ambien?
  6. Serious Side Effects Of Ambien Include:
  7. Active Ingredient:
  8. Inactive Ingredients:

Patient Information 

Prescribers or other healthcare professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with sedative-hypnotics, should counsel them in its appropriate use, and should instruct them to read the accompanying Medication Guide[

After taking AMBIEN, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night.You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with AMBIEN. Reported activities include:

  • driving a car ("sleep-driving")

  • making and eating food

  • talking on the phone

  • having sex

  • sleep-walking

Call your doctor right away if you find out that you have done any of the above activities after taking AMBIEN.

Important: 

1. Take AMBIEN exactly as prescribed
  • Do not take more AMBIEN than prescribed.

  • Take AMBIEN right before you get in bed, not sooner.

2. Do Not Take Ambien If You: 

  • drink alcohol

  • take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take AMBIEN with your other medicines.

  • cannot get a full night's sleep

What Is Ambien? 

AMBIEN is a sedative-hypnotic (sleep) medicine. AMBIEN is used in adults for the short-term treatment of a sleep problem called insomnia. Symptoms of insomnia include:
  • trouble falling asleep

AMBIEN is not for children.

AMBIEN is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep AMBIEN in a safe place to prevent misuse and abuse. Selling or giving away AMBIEN may harm others, and is against the law. Tell your doctor if you have ever abused or have been dependent on alcohol, prescription medicines or street drugs.

Who Should Not Take Ambien? 

Do not take AMBIEN if you are allergic to anything in it.

  • Take AMBIEN exactly as prescribed. Do not take more AMBIEN than prescribed for you.

  • Take AMBIEN right before you get into bed.

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

  • For faster sleep onset, AMBIEN should NOT be taken with or immediately after a meal.

  • 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.

  • If you take too much AMBIEN or overdose, call your doctor or poison control center right away, or get emergency treatment.

Serious Side Effects Of Ambien Include: 

  • getting out of bed while not being fully awake and do an activity that you do not know you are doing.(

    • Store AMBIEN at room temperature, 68 to 77 F (20 to 25 C).

    • Keep AMBIEN and all medicines out of reach of children.

    General Information about AMBIEN

    • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

    • Do not use AMBIEN for a condition for which it was not prescribed.

    • Do not share AMBIEN with other people, even if you think they have the same symptoms that you have. It may harm them and it is against the law.

    This Medication Guide summarizes the most important information about AMBIEN. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about AMBIEN that is written for healthcare professionals. For more information about AMBIEN, call 1-800-633-1610.

Active Ingredient: 

Zolpidem tartrate

Inactive Ingredients: 

hydroxypropyl methylcellulose, lactose, magnesium stearate, micro-crystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. In addition, the 5 mg tablet contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY

May 2012

2012 sanofi-aventis U.S. LLC



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