{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "eszopiclone",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "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",
        "cached_file": "labels/eszopiclone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/eszopiclone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/eszopiclone.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "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",
        "cached_file": "labels/eszopiclone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/eszopiclone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/eszopiclone.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "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",
        "cached_file": "labels/eszopiclone.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "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",
        "cached_file": "labels/eszopiclone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/eszopiclone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/eszopiclone.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/eszopiclone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/eszopiclone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/eszopiclone.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "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",
        "cached_file": "labels/eszopiclone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/eszopiclone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/eszopiclone.json",
        "verbatim": true
      }
    ]
  }
}