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AMBIEN CR- zolpidem tartrate tablet, coated


  1. Patient Information
  2. Ambien Cr May Cause Serious Side Effects That You May Not Know Are Happening To You. These Side Effects Include:
  3. Do Not Take Ambien Cr If You:
  4. Ambien Cr Is A Sedative-hypnotic (sleep) Medicine. Ambien Cr Is Used In Adults For The Treatment Of A Sleep Problem Called Insomnia. Symptoms Of Insomnia Include:
  5. Who Should Not Take Ambien Cr?
  6. Ambien Cr May Not Be Right For You. Before Starting Ambien Cr, Tell Your Healthcare Provider About All Of Your Health Conditions, Including If You:
  7. Ambien Cr May Cause Serious Side Effects Including:
  8. Active Ingredient:
  9. 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[seeMedication Guide (17.4)].

17.1 Severe anaphylactic and anaphylactoid reactions

Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with zolpidem. Describe the signs/symptoms of these reactions and advise patients to seek medical attention immediately if any of them occur.

17.2 Sleep-driving and other complex behaviors

There have been reports of people getting out of bed after taking a sedative-hypnotic and driving their cars while not fully awake, often with no memory of the event. If a patient experiences such an episode, it should be reported to his or her doctor immediately, since "sleep-driving" can be dangerous. This behavior is more likely to occur when Ambien CR is taken with alcohol or other central nervous system depressants[seeWarnings and Precautions (5.3)]. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with "sleep-driving", patients usually do not remember these events.

In addition, patients should be advised to report all concomitant medications to the prescriber. Patients should be instructed to report events such as "sleep-driving" and other complex behaviors immediately to the prescriber.

17.3 Administration instructions

Patients should be counseled to take Ambien right before they get into bed and only when they are able to stay in bed a full night (7 8 hours) before being active again. Ambien CR tablets should not be crushed, divided, or chewed, and should not be taken with or immediately after a meal. Advise patients NOT to take Ambien CR when drinking alcohol.

17.4 Medication Guide

Ambien Cr May Cause Serious Side Effects That You May Not Know Are Happening To You. These Side Effects Include: ⮝

  • sleepiness during the day
  • not thinking clearly
  • act strangely, confused, or upset
  • "sleep-walking" or doing other activities when you are asleep like:
    • eating
    • talking
    • having sex
    • driving a car

Call your healthcare provider right away if you find out that you have done any of the above activities after taking 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 Cr If You: ⮝

  • drank alcohol that evening or before bed.
  • take other medicines that can make you sleepy. Taking AMBIEN CR with other drugs can cause side effects. Talk to your healthcare provider about all of your medicines. Your healthcare provider will tell you if you can take AMBIEN CR with your other medicines.
  • cannot get a full night's sleep.

Ambien Cr Is A Sedative-hypnotic (sleep) Medicine. Ambien Cr Is Used In Adults For The Treatment Of A Sleep Problem Called Insomnia. Symptoms Of Insomnia Include: ⮝

  • trouble falling asleep
  • waking up often during the night

AMBIEN CR is not recommended for use in children under the age of 18 years.

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

Who Should Not Take Ambien Cr? ⮝

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

Ambien Cr May Not Be Right For You. Before Starting Ambien Cr, Tell Your Healthcare Provider About All Of Your Health 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, planning to become pregnant. Talk to your healthcare provider about the risk to your unborn baby if you take AMBIEN CR.
  • Using AMBIEN CR in the last trimester of pregnancy may cause breathing difficulties or excess sleepiness in your newborn. Monitor for signs of sleepiness (more than usual), trouble breathing, or limpness in the newborn if AMBIEN CR is taken late in pregnancy.
  • are breastfeeding or plan to breastfeed. AMBIEN CR passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while you take AMBIEN CR.

Tell your healthcare provider about all of the medicines you take,including prescription and nonprescription medicines, vitamins and herbal supplements.

Medicines can interact with each other, sometimes causing serious side effects.Do not take AMBIEN CR with other medicines that can make you sleepy unless your healthcare provider tells you to.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.

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.(

    Store AMBIEN CR at room temperature, 59 F to 77 F (15 C to 25 C).

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

    General Information about the safe and effective use of AMBIEN CR

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AMBIEN CR for a condition for which it was not prescribed. Do not share AMBIEN CR with other people, even if 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 CR. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about AMBIEN CR that is written for healthcare professionals.

    For more information, go to www.ambiencr.com or call 1-800-633-1610.

Active Ingredient: ⮝

Zolpidem tartrate

Inactive Ingredients: ⮝

The 6.25 mg tablets contain: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, red ferric oxide, sodium starch glycolate, and titanium dioxide.

The 12.5 mg tablets contain: colloidal silicon dioxide, FD&C Blue #2, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, sodium starch glycolate, titanium dioxide, and yellow ferric oxide.

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

Revised: February 2019

2019 sanofi-aventis U.S. LLC


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