Eszopiclone

DRUG INFORMATION

  ADULT
    - DOSAGE & ADMINISTRATION Use the lowest effective dose for the patient. • Use the
      lowest dose effective for the patient ( 2 ) • Recommended initial dose is 1 mg,
      immediately before bedtime, with at least 7 to 8 hours remaining before the
      planned time of awakening.
      Source: US FDA label for eszopiclone (Eszopiclone), section 'dosage and
      administration', retrieved 2026-08-29
    - May increase dose if clinically indicated, to a maximum of 3 mg ( 2.1 ) •
      Geriatric or debilitated patients: Dose should not exceed 2 mg ( 2.2 ) • Patients
      with severe hepatic impairment, or taking potent CYP3A4 inhibitors: Dose should
      not exceed 2 mg ( 2.3 ) • Do not take with or immediately after a meal ( 2.5 ) 2.1
      Dosage in Adults The recommended starting dose is 1 mg.
      Source: US FDA label for eszopiclone (Eszopiclone), section 'dosage and
      administration', retrieved 2026-08-29
    - In some patients, the higher morning blood levels of eszopiclone tablets 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) ].
      Source: US FDA label for eszopiclone (Eszopiclone), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness of eszopiclone tablets have not been established in
      pediatric patients. Eszopiclone tablets failed to demonstrate efficacy in
      controlled clinical studies of pediatric patients with Attention-
      Deficit/Hyperactivity (ADHD) associated insomnia.
      Source: US FDA label for eszopiclone (Eszopiclone), section 'pediatric use',
      retrieved 2026-08-29
    - In studies in which eszopiclone (2 to 300 mg/kg/day) was orally administered to
      young rats from weaning through sexual maturity, neurobehavioral impairment
      (altered auditory startle response) and reproductive toxicity (adverse effects on
      male reproductive organ weights and histopathology) were observed at doses ≥5
      mg/kg/day.
      Source: US FDA label for eszopiclone (Eszopiclone), section 'pediatric use',
      retrieved 2026-08-29
    - Delayed sexual maturation was noted in males and females at ≥10 mg/kg/day.
      Source: US FDA label for eszopiclone (Eszopiclone), section 'pediatric use',
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - No dose adjustment appears necessary in subjects with any degree of renal
      impairment, since less than 10% of eszopiclone is excreted unchanged in the urine.
      Source: US FDA label for eszopiclone (Eszopiclone), section 'warnings and
      cautions', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - May increase dose if clinically indicated, to a maximum of 3 mg ( 2.1 ) •
      Geriatric or debilitated patients: Dose should not exceed 2 mg ( 2.2 ) • Patients
      with severe hepatic impairment, or taking potent CYP3A4 inhibitors: Dose should
      not exceed 2 mg ( 2.3 ) • Do not take with or immediately after a meal ( 2.5 ) 2.1
      Dosage in Adults The recommended starting dose is 1 mg.
      Source: US FDA label for eszopiclone (Eszopiclone), section 'dosage and
      administration', retrieved 2026-08-29
    - The total dose of eszopiclone tablets 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 tablets should not exceed 2
      mg in elderly or debilitated patients.
      Source: US FDA label for eszopiclone (Eszopiclone), section 'dosage and
      administration', retrieved 2026-08-29
    - Therefore, dose reduction is recommended in elderly patients [see Dosage and
      Administration (2.2) , Clinical Pharmacology (12.3) ] . 8.6 Hepatic Impairment No
      dose adjustment is necessary for patients with mild-to-moderate hepatic
      impairment.
      Source: US FDA label for eszopiclone (Eszopiclone), section 'use in specific
      populations', retrieved 2026-08-29

  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, or adverse maternal or fetal outcomes.
      Source: US FDA label for eszopiclone (Eszopiclone), section 'pregnancy', retrieved
      2026-08-29
    - In animal reproduction studies conducted in pregnant rats and rabbits throughout
      organogenesis, there was no evidence of teratogenicity.
      Source: US FDA label for eszopiclone (Eszopiclone), section 'pregnancy', retrieved
      2026-08-29
    - Administration of eszopiclone to rats throughout pregnancy and lactation resulted
      in offspring toxicities at all doses tested; the lowest dose was approximately 200
      times the maximum recommended human dose (MRHD) of 3 mg/day based on mg/m 2 body
      surface area (See Data).
      Source: US FDA label for eszopiclone (Eszopiclone), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Risk Summary There are no data on the presence of eszopiclone in either human or
      animal milk, the effects on the breastfed infant, or the effects on milk
      production.
      Source: US FDA label for eszopiclone (Eszopiclone), section 'nursing mothers',
      retrieved 2026-08-29
    - The developmental and health benefits of breastfeeding should be considered along
      with the mother’s clinical need for eszopiclone and any potential adverse effects
      on the breastfed infant from eszopiclone or from the underlying maternal
      condition.
      Source: US FDA label for eszopiclone (Eszopiclone), section 'nursing mothers',
      retrieved 2026-08-29
    - Administration of eszopiclone to rats throughout pregnancy and lactation resulted
      in offspring toxicities at all doses tested; the lowest dose was approximately 200
      times the maximum recommended human dose (MRHD) of 3 mg/day based on mg/m 2 body
      surface area (See Data).
      Source: US FDA label for eszopiclone (Eszopiclone), section 'use in specific
      populations', retrieved 2026-08-29