Label: ESZOPICLONE tablet, film coated

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

Drug Label Information

Updated December 12, 2024

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

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ESZOPICLONE TABLETS safely and effectively. See full prescribing information for ESZOPICLONE TABLETS. ESZOPICLONE tablets ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: COMPLEX SLEEP BEHAVIORS

    Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of eszopiclone. Some of these events may result in serious injuries, including death. Discontinue eszopiclone immediately if a patient experiences a complex sleep behavior [see  Contraindications (4) and Warnings and Precautions (5.1)].

    Close
  • 1 INDICATIONS AND USAGE
    Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and ...
  • 2 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 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Eszopiclone tablets USP are available in 2 mg strength for oral administration. Eszopiclone 2 mg tablets are white to off-white, film-coated, round shaped, biconvex tablets with debossed ‘K’ on ...
  • 4 CONTRAINDICATIONS
    Eszopiclone tablets are contraindicated in patients who have experienced complex sleep behaviors after taking Eszopiclone tablets - [see - Warnings and Precautions ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Complex Sleep Behaviors - Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following the first or any ...
  • 6 ADVERSE REACTIONS
    The following are described in more detail in the - Warnings and Precautions section of the label: Complex Sleep Behaviors - [see  - Boxed ...
  • 7 DRUG INTERACTIONS
    7.1 CNS Active Drugs - Ethanol: An additive effect on psychomotor performance was seen with coadministration of eszopiclone and ethanol - [see - Warnings and ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Available pharmacovigilance data with eszopiclone use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - Eszopiclone is a Schedule IV controlled substance under the Controlled Substances Act.  Other substances under the same classification are benzodiazepines and the ...
  • 10 OVERDOSAGE
    In clinical trials with eszopiclone, one case of overdose with up to 36 mg of eszopiclone was reported in which the subject fully recovered. Since commercial marketing began, spontaneous cases of ...
  • 11 DESCRIPTION
    Eszopiclone is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The mechanism of action of eszopiclone as a hypnotic is unclear; however, its effect could be related to its interaction with GABA-receptor complexes at binding domains ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - In a carcinogenicity study in rats, oral administration of eszopiclone for 97 (males) or 104 ...
  • 14 CLINICAL STUDIES
    The effect of eszopiclone on reducing sleep latency and improving sleep maintenance was established in studies with 2100 subjects (ages 18 to 86) with chronic and transient insomnia in six ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Eszopiclone Tablets USP 2 mg are white to off-white, film-coated, round shaped, biconvex tablets with debossed ‘K’ on one side and ‘84’ on other side. NDC: 70518-1310-00 - PACKAGING: 30 in 1 BOTTLE ...
  • 17 PATIENT COUNSELING INFORMATION
    See FDA-approved patient labeling ( Medication Guide). Inform patients and their families about the benefits and risks of treatment with eszopiclone. Inform patients of the availability of a ...
  • MEDICATION GUIDE
    Eszopiclone Tablets USP CIV - (es-zoe’-pi-klone) Read the Medication Guide that comes with eszopiclone tablets before you start taking them and each time you get a refill. There ...
  • PRINCIPAL DISPLAY PANEL
    DRUG: ESZOPICLONE - GENERIC: ESZOPICLONE - DOSAGE: TABLET, FILM COATED - ADMINSTRATION: ORAL - NDC: 70518-1310-0 - COLOR: white - SHAPE: ROUND - SCORE: No score - SIZE: 6 mm - IMPRINT: K;84 - PACKAGING: 30 in 1 ...
  • INGREDIENTS AND APPEARANCE
    Product Information