Label: ESZOPICLONE tablet, film coated

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

Drug Label Information

Updated December 2, 2015

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  • Indications and Usage

  • Dosage and Administration

    Use the lowest effective dose for the patient.

    2.1 Dosage in Adults

    The recommended starting dose is 1 mg. Dosing can be raised to 2 mg or 3 mg if clinically indicated. In some patients, the higher morning blood levels of eszopiclone following use of the 2 mg or 3 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of eszopiclone should not exceed 3 mg, once daily immediately before bedtime [see Warnings and Precautions (5.6)].

    2.2 Geriatric or Debilitated Patients

    The total dose of eszopiclone should not exceed 2 mg in elderly or debilitated patients.

    2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors

    In patients with severe hepatic impairment, or in patients coadministered eszopiclone tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone should not exceed 2 mg [see Warnings and Precautions (5.7)].

    2.4 Use with CNS Depressants

    Dosage adjustments may be necessary when eszopiclone tablets are combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].

    2.5 Administration with Food

    Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Clinical Pharmacology (12.3)].

  • Dosage forms and strengths

  • Contraindications

    Eszopiclone is contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.3)].

  • Warnings and Precautions

  • Adverse Reactions

  • Drug Interactions

  • Use in Specific Populations

  • Drug abuse and Dependence

  • Overdosage

  • Description

  • Clinical Pharmacology

  • Nonclinical Toxicology

  • Clinical Studies

  • Information for Patients

  • Medication Guide

  • Package Label

    Label

  • INGREDIENTS AND APPEARANCE
    ESZOPICLONE 
    eszopiclone tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61919-991(NDC:68462-382)
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESZOPICLONE (UNII: UZX80K71OE) (ESZOPICLONE - UNII:UZX80K71OE) ESZOPICLONE1 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorblue (light blue) Scoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 382;G
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-991-9090 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09116612/01/2015
    Labeler - DirectRX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DirectRX079254320repack(61919-991)