Ambien zolpidem tartrate

Get an overview of AMBIEN (zolpidem tartrate tablet, film coated), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Ambien can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Ambien.

Drug Basics

Brand Name: Ambien

Generic Name: ZOLPIDEM TARTRATE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET, FILM COATED

Data Current As Of: 2019-09-09

Boxed Warning 08/2019
Contraindications (4) 08/2019
Warnings and Precautions, Complex Sleep Behaviors (5.1) 08/2019
Warnings and Precautions, CNS-Depressant Effects and Next-Day Impairment (5.2) 02/2019

indications & usage

AMBIEN (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. AMBIEN has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)].

The clinical trials performed in support of efficacy were 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.

AMBIEN, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. (1)

patient counseling information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Inform patients and their families about the benefits and risks of treatment with AMBIEN. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with AMBIEN and with each prescription refill. Review the AMBIEN Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that AMBIEN should be taken only as prescribed.

Complex Sleep Behaviors

Instruct patients and their families that AMBIEN may cause complex sleep behaviors, including sleep-walking, sleep-driving, preparing and eating food, making phone calls, or having sex while not being fully awake. Serious injuries and death have occurred during complex sleep behavior episodes. Tell patients to discontinue AMBIEN and notify their healthcare provider immediately if they develop any of these symptoms [see Boxed Warning, Warnings and Precautions (5.1)].

CNS-Depressant Effects and Next-Day Impairment

Tell patients that AMBIEN has the potential to cause next-day impairment, and that this risk is increased if dosing instructions are not carefully followed. Tell patients to wait for at least 8 hours after dosing before driving or engaging in other activities requiring full mental alertness. Inform patients that impairment can be present despite feeling fully awake. Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients [see Warnings and Precautions (5.2)].

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 [see Warnings and Precautions (5.4)].

Suicide

Tell patients to immediately report any suicidal thoughts.

Alcohol and other Drugs

Ask patients about alcohol consumption, medicines they are taking, and drugs they may be taking without a prescription. Advise patients not to use AMBIEN if they drank alcohol that evening or before bed.

Tolerance, Abuse, and Dependence

Tell patients not to increase the dose of AMBIEN on their own, and to inform you if they believe the drug "does not work."

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 tablets should not be taken with or immediately after a meal. Advise patients NOT to take AMBIEN if they drank alcohol that evening.

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with AMBIEN. Advise patients that use of AMBIEN late in the third trimester may cause respiratory depression and sedation in neonates. Advise mothers who used AMBIEN during the late third trimester of pregnancy to monitor neonates for signs of sleepiness (more than usual), breathing difficulties, or limpness [see Use in Specific Populations (8.1)].

Lactation

Advise breastfeeding mothers using AMBIEN to monitor infants for increased sleepiness, breathing difficulties, or limpness. Instruct breastfeeding mothers to seek immediate medical care if they notice these signs. A lactating woman may consider pumping and discarding breastmilk during treatment and for 23 hours after AMBIEN administration to minimize drug exposure to a breastfed infant [ see Use in Specific Populations (8.2)].

MEDICATION GUIDE
AMBIEN® (ām'bē–ən)
(zolpidem tartrate) tablets C-IV

Read the Medication Guide that comes with AMBIEN before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

What is the most important information I should know about AMBIEN?

  • Do not take more AMBIEN than prescribed.
  • Do not take AMBIEN unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again.
  • Take AMBIEN right before you get in bed, not sooner.

AMBIEN may cause serious side effects, including:

  • complex sleep behaviors that have caused serious injury and death. 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 (complex sleep behaviors). The next morning, you may not remember that you did anything during the night. These activities may occur with AMBIEN 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 and call your healthcare provider right away if you find out that you have done any of the above activities after taking AMBIEN.

Do not take AMBIEN 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.
  • drank alcohol that evening or before bed
  • took another medicine to help you 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 (trouble falling asleep).

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

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 healthcare provider 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 zolpidem or any other ingredients in AMBIEN. See the end of this Medication Guide for a complete list of ingredients in AMBIEN.
  • Do not take AMBIEN 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

What should I tell my healthcare provider before taking AMBIEN?

AMBIEN may not be right for you. Before starting AMBIEN, 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.
  • Using AMBIEN 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 is taken late in pregnancy.
  • are breastfeeding or plan to breastfeed. AMBIEN passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while you take AMBIEN.

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 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.

How should I take AMBIEN?

  • See "What is the most important information I should know about AMBIEN?"
  • Take AMBIEN exactly as prescribed. Only take 1 AMBIEN tablet a night if needed.
  • Do not take AMBIEN if you drank alcohol that evening or before bed.
  • You should not take AMBIEN with or right after a meal. AMBIEN may help you fall asleep faster if you take it on an empty stomach.
  • Call your healthcare provider 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, get emergency treatment.

What are the possible side effects of AMBIEN?

AMBIEN may cause serious side effects, including:

  • getting out of bed while not being fully awake and do an activity that you do not know you are doing. See " What is the most important information I should know about AMBIEN? "
  • abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions.
  • 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.

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.

The most common side effects of AMBIEN are:

After you stop taking a sleep medicine, you may have symptoms for 1 to 2 days such as:

These are not all the side effects of AMBIEN. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–1088.

How should I store AMBIEN?

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

Keep AMBIEN and all medicines out of reach of children.

General Information about the safe and effective use of 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 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 healthcare provider. You can ask your healthcare provider or pharmacist for information about AMBIEN that is written for healthcare professionals.

For more information, call 1-800-633-1610.

What are the ingredients in AMBIEN?

Active Ingredient: Zolpidem tartrate

Inactive Ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline 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

Revised: August 2019

©2019 sanofi-aventis U.S. LLC

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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