Label: AMBIEN- zolpidem tartrate 10mg tablet, coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 19, 2020

If you are a consumer or patient please visit this version.

  • Dosage and Administration Section

    2 DOSAGE AND ADMINISTRATION

    2.1 Dosage in Adults

    Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next-day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.2)]. The total dose of zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime. Zolpidem tartrate tablets should be taken as a single dose and should not be readministered during the same night.

    The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

    2.2 Special Populations

    Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. The recommended dose of zolpidem tartrate tablets in these patients is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.2), Use in Specific Populations (8.5)].

    Patients with mild to moderate hepatic impairment do not clear the drug as rapidly as normal subjects. The recommended dose of zolpidem tartrate tablets in these patients is 5 mg once daily immediately before bedtime. Avoid zolpidem tartrate tablets use in patients with severe hepatic impairment as it may contribute to encephalopathy [see Warnings and Precautions (5.8), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

    2.3 Use with CNS Depressants

    Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS-depressant drugs because of the potentially additive effects [seeWarnings and Precautions (5.2)].

    2.4 Administration

    The effect of zolpidem tartrate tablets may be slowed by ingestion with or immediately after a meal.

  • Indications and Usage Section

    1 INDICATIONS AND USAGE

    Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have 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 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.

  • Medication Guide

    MEDICATION GUIDE

    Medication Guide
    Zolpidem Tartrate Tablets, USP C-IV

    (ZOL-pih-dem)

    Read the Medication Guide that comes with zolpidem tartrate tablets 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 zolpidem tartrate tablets?


    Do not take more zolpidem tartrate tablets than prescribed.

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

    Take zolpidem tartrate tablets right before you get in bed, not sooner.

    Zolpidem tartrate tablets may cause serious side effects, including:


    Complex sleep behaviors that have caused serious injury and death. After taking zolpidem tartrate tablets, 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 zolpidem tartrate tablets 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 zolpidem tartrate tablets and call your healthcare provider right away if you find out that you have done any of the above activities after taking zolpidem tartrate tablets.

    Do not take zolpidem tartrate tablets 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 zolpidem tartrate tablets.

    drank alcohol that evening or before bed

    took another medicine to help you sleep.

    What are zolpidem tartrate tablets?

    Zolpidem tartrate tablets are a sedative-hypnotic (sleep) medicine. Zolpidem tartrate tablets are used in adults for the short-term treatment of a sleep problem called insomnia (trouble falling asleep).

    Zolpidem tartrate tablets are not recommended for use in children under the age of 18 years.

    Zolpidem tartrate tablets are a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep zolpidem tartrate tablets in a safe place to prevent misuse and abuse. Selling or giving away zolpidem tartrate tablets 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 zolpidem tartrate tablets?


    Do not take zolpidem tartrate tablets if you are allergic to zolpidem or any other ingredients in zolpidem tartrate tablets. See the end of this Medication Guide for a complete list of ingredients in zolpidem tartrate tablets.

    Do not take zolpidem tartrate tablets if you have had an allergic reaction to drugs containing zolpidem, such as zolpidem tartrate extended-release tablets, 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 zolpidem tartrate tablets?

    Zolpidem tartrate tablets may not be right for you. Before starting zolpidem tartrate tablets, 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 zolpidem tartrate tablets.

    Using zolpidem tartrate tablets 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 zolpidem tartrate tablets are taken late in pregnancy.

    are breastfeeding or plan to breastfeed. Zolpidem tartrate passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while you take zolpidem tartrate tablets.

    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 zolpidem tartrate tablets 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 zolpidem tartrate tablets?


    See "What is the most important information I should know about zolpidem tartrate tablets?"

    Take zolpidem tartrate tablets exactly as prescribed. Only take one zolpidem tartrate tablet a night if needed.

    Do not take zolpidem tartrate tablets if you drank alcohol that evening or before bed.

    You should not take zolpidem tartrate tablets with or right after a meal. Zolpidem tartrate tablets 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 many zolpidem tartrate tablets or overdose, get emergency treatment.

    What are the possible side effects of zolpidem tartrate tablets?

    Zolpidem tartrate tablets 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 zolpidem tartrate tablets?"

    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 zolpidem tartrate tablets.

    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 zolpidem tartrate tablets.

    The most common side effects of zolpidem tartrate tablets are:


    drowsiness

    dizziness

    diarrhea

    grogginess or feeling as if you have been drugged

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


    trouble sleeping

    nausea

    flushing

    lightheadedness

    uncontrolled crying

    vomiting

    stomach cramps

    panic attack

    nervousness

    stomach area pain

    These are not all the side effects of zolpidem tartrate tablets. 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 zolpidem tartrate tablets?

    Store zolpidem tartrate tablets at room temperature, 68°F to 77°F (20°C to 25°C).

    Keep zolpidem tartrate tablets and all medicines out of reach of children.

    General Information about the safe and effective use of zolpidem tartrate tablets

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

    For more information about zolpidem tartrate tablets, call Sandoz Inc. at 1-800-525-8747.

    What are the ingredients in zolpidem tartrate tablets?

    Active Ingredient: Zolpidem tartrate

    Inactive Ingredients: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, hypromellose, hydroxypropyl cellulose, polyethylene glycol, talc, titanium dioxide, carnauba wax; the 10-mg tablet also contains ferric oxide yellow.

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

    The brands listed are trademarks of their respective owners and are not trademarks of Sandoz Inc.

    Finished Drug Product Manufactured by Lek Pharmaceuticals d.d.

    SI-1526 Ljubljana, Slovenia for Sandoz Inc., Princeton, NJ 08540

    Rev. September 2019

  • Principal Display Panel

    Zolpidem Tartrate 10mg

  • INGREDIENTS AND APPEARANCE
    AMBIEN 
    zolpidem tartrate 10mg tablet, coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80425-0060(NDC:0781-5318)
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZOLPIDEM TARTRATE (UNII: WY6W63843K) (ZOLPIDEM - UNII:7K383OQI23) ZOLPIDEM TARTRATE10 mg
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize7mm
    FlavorImprint Code ZLP;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80425-0060-130 in 1 BOTTLE; Type 0: Not a Combination Product04/23/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07732204/23/2007
    Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0060)