Midazolam

DRUG INFORMATION

  ADULT
    - Dosing Recommendations for Continuous Intravenous Infusion in Adult, Pediatric,
      and Neonatal Patients ADULT PATIENTS If a loading dose is necessary to rapidly
      initiate sedation, 0.01 mg/kg to 0.05 mg/kg (approximately 0.5 mg to 4 mg for a
      typical adult) may be given slowly or infused over several minutes.
      Source: US FDA label for midazolam (Midazolam in Sodium Chloride), section 'dosage
      and administration', retrieved 2026-08-29
    - DOSING AND ADMINISTRATION For intravenous injection only. Avoid intra-arterial
      injection or extravasation. ( 2.1 ) Individualize dosing and titrate to desired
      clinical response, taking into account patient age, clinical status, and
      concomitant use of other CNS depressants. ( 2.1 ) See Full Prescribing Information
      for complete dosage and administration information.
      Source: US FDA label for midazolam (Midazolam in Sodium Chloride), section 'dosage
      and administration', retrieved 2026-08-29

  CHILD
    - The safety and efficacy of midazolam for sedation/anxiolysis/amnesia following
      continuous infusion have been established in pediatric and neonatal patients.
      UNLIKE ADULT PATIENTS, PEDIATRIC PATIENTS GENERALLY RECEIVE INCREMENTS OF
      MIDAZOLAM ON A MG/KG BASIS. As a group, pediatric patients generally require
      higher dosages of midazolam (mg/kg) than do adults.
      Source: US FDA label for midazolam (Midazolam in Sodium Chloride), section
      'pediatric use', retrieved 2026-08-29
    - DOSING AND ADMINISTRATION For intravenous injection only. Avoid intra-arterial
      injection or extravasation. ( 2.1 ) Individualize dosing and titrate to desired
      clinical response, taking into account patient age, clinical status, and
      concomitant use of other CNS depressants. ( 2.1 ) See Full Prescribing Information
      for complete dosage and administration information.
      Source: US FDA label for midazolam (Midazolam in Sodium Chloride), section 'dosage
      and administration', retrieved 2026-08-29
    - Dosing Recommendations for Continuous Intravenous Infusion in Adult, Pediatric,
      and Neonatal Patients ADULT PATIENTS If a loading dose is necessary to rapidly
      initiate sedation, 0.01 mg/kg to 0.05 mg/kg (approximately 0.5 mg to 4 mg for a
      typical adult) may be given slowly or infused over several minutes.
      Source: US FDA label for midazolam (Midazolam in Sodium Chloride), section 'dosage
      and administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - No kidney-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for midazolam (Midazolam in Sodium
      Chloride), retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for midazolam (Midazolam in Sodium
      Chloride), retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Neonates born to mothers using benzodiazepines, including midazolam,
      late in pregnancy have been reported to experience symptoms of sedation and/or
      neonatal withdrawal [see Warnings and Precautions (5.10 ), and Clinical
      Considerations ] .
      Source: US FDA label for midazolam (Midazolam in Sodium Chloride), section
      'pregnancy', retrieved 2026-08-29
    - Available data from published observational studies of pregnant women exposed to
      benzodiazepines do not report a clear association with benzodiazepines and major
      birth defects (see Data) .
      Source: US FDA label for midazolam (Midazolam in Sodium Chloride), section
      'pregnancy', retrieved 2026-08-29
    - Available data from randomized controlled trials, cohort studies and case reports
      over several decades with midazolam use in pregnant women for anesthesia have not
      identified a drug-associated risk of major birth defects, miscarriage, or adverse
      maternal or fetal outcomes.
      Source: US FDA label for midazolam (Midazolam in Sodium Chloride), section
      'pregnancy', retrieved 2026-08-29

  BREASTFEEDING
    - Lactation: A lactating woman may pump and discard breast milk for 4 to 8 hours
      after treatment with midazolam.
      Source: US FDA label for midazolam (Midazolam in Sodium Chloride), section 'use in
      specific populations', retrieved 2026-08-29
    - Pregnant rats were administered midazolam using intravenous doses of 0.2, 1, and 4
      mg/kg/day (0.09, 0.46, and 1.85 times the human induction dose of 0.35 mg/kg based
      on body surface area comparisons) during late gestation and through lactation
      (Gestation Day 15 through Lactation Day 21).
      Source: US FDA label for midazolam (Midazolam in Sodium Chloride), section 'use in
      specific populations', retrieved 2026-08-29
    - The clinical significance of these findings is not clear; however, studies in
      juvenile animals suggest neuroapoptosis correlates with long-term cognitive
      deficits [see Warnings and Precautions (5.8 ), Use in Specific Populations (8.4 ),
      Nonclinical Pharmacology (13.2) ]. 8.2 Lactation Risk Summary There are reports of
      sedation, poor feeding, and poor weight gain in infants exposed to benzodiazepines
      through breast milk.
      Source: US FDA label for midazolam (Midazolam in Sodium Chloride), section 'use in
      specific populations', retrieved 2026-08-29