{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "zolpidem",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening.",
        "source": "US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/zolpidem.json",
        "verbatim": true
      },
      {
        "text": "If the 5 mg dose is not effective, the dose can be increased to 10 mg.",
        "source": "US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/zolpidem.json",
        "verbatim": true
      },
      {
        "text": "In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next-day impairment of driving and other activities that require full alertness [see Warnings and Precautions ( 5.2 )] .",
        "source": "US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/zolpidem.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Zolpidem tartrate tablets are not recommended for use in children. Safety and effectiveness of zolpidem in pediatric patients below the age of 18 years have not been established. In an 8-week study in pediatric patients (aged 6 to 17 years) with insomnia associated with attention-deficit/hyperactivity disorder (ADHD) an oral solution of zolpidem tartrate dosed at 0.25 mg/kg at bedtime did not decrease sleep latency compared to placebo.",
        "source": "US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/zolpidem.json",
        "verbatim": true
      },
      {
        "text": "In an 8-week study in pediatric patients (aged 6 to 17 years) with insomnia associated with attention-deficit/hyperactivity disorder (ADHD) an oral solution of zolpidem tartrate dosed at 0.25 mg/kg at bedtime did not decrease sleep latency compared to placebo.",
        "source": "US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/zolpidem.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "No kidney-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for zolpidem (ZOLPIDEM TARTRATE), retrieved 2026-08-29",
        "cached_file": "labels/zolpidem.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "Patients with mild to moderate hepatic impairment do not clear the drug as rapidly as normal subjects.",
        "source": "US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/zolpidem.json",
        "verbatim": true
      },
      {
        "text": "Avoid zolpidem tartrate tablets use in patients with severe hepatic impairment as it may contribute to encephalopathy [see Warnings and Precautions ( 5.8 ), Use in Specific Populations ( 8.7 ), Clinical Pharmacology ( 12.3 )]. 2.3 Use with CNS Depressants Dosage adjustment may be necessary when zolpidem tartrate tablets are combined with other CNS-depressant drugs because of the potentially additive effects [see Warnings and Precautions ( 5.2 , 5.7 )] .",
        "source": "US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/zolpidem.json",
        "verbatim": true
      },
      {
        "text": "The recommended dose of zolpidem tartrate tablets in geriatric patients is 5 mg regardless of gender. 8.7 Hepatic Impairment The recommended dose of zolpidem tartrate tablets in patients with mild to moderate hepatic impairment is 5 mg once daily immediately before bedtime.",
        "source": "US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/zolpidem.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation [see Clinical Considerations and Data] .",
        "source": "US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/zolpidem.json",
        "verbatim": true
      },
      {
        "text": "Published data on the use of zolpidem during pregnancy have not reported a clear association with zolpidem and major birth defects [see Data].",
        "source": "US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/zolpidem.json",
        "verbatim": true
      },
      {
        "text": "Oral administration of zolpidem to pregnant rats and rabbits did not indicate a risk for adverse effects on fetal development at clinically relevant doses [see Data].",
        "source": "US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/zolpidem.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Risk Summary Limited data from published literature report the presence of zolpidem in human milk.",
        "source": "US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/zolpidem.json",
        "verbatim": true
      },
      {
        "text": "There are reports of excess sedation in infants exposed to zolpidem through breastmilk [see Clinical Considerations].",
        "source": "US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/zolpidem.json",
        "verbatim": true
      },
      {
        "text": "There is no information on the effects of zolpidem on milk production.",
        "source": "US FDA label for zolpidem (ZOLPIDEM TARTRATE), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/zolpidem.json",
        "verbatim": true
      }
    ]
  }
}