Label: ESZOPICLONE- eszopiclone tablet, film coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL

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)].

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  • 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)].

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  • 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
  • INGREDIENTS AND APPEARANCE
    ESZOPICLONE 
    eszopiclone tablet, film coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-991(NDC:68462-382)
    Route of Administration ORAL DEA Schedule CIV    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ESZOPICLONE (UNII: UZX80K71OE) (ESZOPICLONE - UNII:UZX80K71OE) ESZOPICLONE 1 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color blue (light blue) Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code 382;G
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61919-991-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2015
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA091166 12/01/2015
    Labeler - DirectRX (079254320)
    Establishment
    Name Address ID/FEI Business Operations
    DirectRX 079254320 repack(61919-991)
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