Diazepam

DRUG INFORMATION

  ADULT
    - ( 2.2 ) Initial Dose: VALTOCO 5 mg and 10 mg doses are administered as a single
      spray intranasally into one nostril.
      Source: US FDA label for diazepam (Valtoco), section 'dosage and administration',
      retrieved 2026-08-29
    - Administration of 15 mg and 20 mg doses requires two nasal spray devices, one
      spray into each nostril.
      Source: US FDA label for diazepam (Valtoco), section 'dosage and administration',
      retrieved 2026-08-29
    - ( 2.2 ) 2.1 Instructions Prior to Dosing Prior to treatment, healthcare
      professionals should instruct the individual administering VALTOCO on how to
      identify seizure clusters and use the product appropriately [see Dosage and
      Administration (2.3) and Patient Counseling Information (17) ]. 2.2 Dosing
      Information The recommended dose of VALTOCO nasal spray is 0.2 mg/kg to 0.5 mg/kg,
      depending on the patient's age and weight.
      Source: US FDA label for diazepam (Valtoco), section 'dosage and administration',
      retrieved 2026-08-29

  CHILD
    - Administer VALTOCO by the nasal route only. ( 2.3 ) Dosage is dependent on the
      patient's age and weight. ( 2.2 ) Initial Dose: VALTOCO 5 mg and 10 mg doses are
      administered as a single spray intranasally into one nostril. Administration of 15
      mg and 20 mg doses requires two nasal spray devices, one spray into each nostril.
      ( 2.2 ) Second Dose: A second dose, when required, may be administered at least 4
      hours after the initial dose.
      Source: US FDA label for diazepam (Valtoco), section 'dosage and administration',
      retrieved 2026-08-29
    - In these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels
      of benzyl alcohol and its metabolites in the blood and urine (blood levels of
      benzyl alcohol were 0.61 to 1.378 mmol/L).
      Source: US FDA label for diazepam (Valtoco), section 'pediatric use', retrieved
      2026-08-29
    - ( 2.2 ) 2.1 Instructions Prior to Dosing Prior to treatment, healthcare
      professionals should instruct the individual administering VALTOCO on how to
      identify seizure clusters and use the product appropriately [see Dosage and
      Administration (2.3) and Patient Counseling Information (17) ]. 2.2 Dosing
      Information The recommended dose of VALTOCO nasal spray is 0.2 mg/kg to 0.5 mg/kg,
      depending on the patient's age and weight.
      Source: US FDA label for diazepam (Valtoco), 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 diazepam (Valtoco), 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 diazepam (Valtoco), retrieved
      2026-08-29

  PREGNANCY
    - Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors
      pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as
      VALTOCO, during pregnancy.
      Source: US FDA label for diazepam (Valtoco), section 'pregnancy', retrieved
      2026-08-29
    - Healthcare providers are encouraged to recommend that pregnant women who are
      taking VALTOCO during pregnancy enroll in the North American Antiepileptic Drug
      (NAAED) Pregnancy Registry by calling 1-888-233-2334 or visiting
      http://www.aedpregnancyregistry.org.
      Source: US FDA label for diazepam (Valtoco), section 'pregnancy', retrieved
      2026-08-29
    - Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have
      been reported to experience symptoms of sedation and/or neonatal withdrawal [see
      Warnings and Precautions (5.7) and Clinical Considerations ] .
      Source: US FDA label for diazepam (Valtoco), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - The window of vulnerability to these changes in rats (postnatal days 0-14)
      includes a period of brain development that takes place during the third trimester
      of pregnancy in humans. 8.2 Lactation Risk Summary Diazepam is excreted in human
      milk.
      Source: US FDA label for diazepam (Valtoco), section 'use in specific
      populations', retrieved 2026-08-29
    - There are reports of sedation, poor feeding, and poor weight gain in infants
      exposed to benzodiazepines through breast milk.
      Source: US FDA label for diazepam (Valtoco), section 'use in specific
      populations', retrieved 2026-08-29
    - The developmental and health benefits of breastfeeding should be considered along
      with the mother's clinical need for VALTOCO nasal spray and any potential adverse
      effects on the breastfed infant from VALTOCO or from the underlying maternal
      condition.
      Source: US FDA label for diazepam (Valtoco), section 'use in specific
      populations', retrieved 2026-08-29