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1.2. Pediatrics

Safety and effectiveness of alprazolam and combination therapies, chlordiazepoxide/amitriptyline and chlordiazepoxide/clidinium, in children less than 18 years of age have not been established1-3,19,20. Additionally, safety and effectiveness of Loreev XR (lorazepam) has not been established in pediatric patients, and the safety and effectiveness of Nayzilam (midazolam) has not been established in pediatric patients less than 12 years of age1,2,4,17.

Clobazam formulations are approved for use in children 2 years of age and older to manage seizures associated with Lennox-Gastaut syndrome1,2,11,15. The diazepam nasal formulation (Valtoco) is FDA-approved for use in patients 6 years and older to treat intermittent frequent seizure episodes that differ from a patient’s usual seizure pattern1,2,16.

Except for alprazolam, non-sedative/hypnotic benzodiazepines are indicated for use in pediatric patients to manage anxiety or seizures1-18. Pediatric dosages and age limitations for benzodiazepines are summarized in Table 3.

Table 3. Pediatric Benzodiazepine Maximum Recommended Dosages1,2,5-17
Drug NameTreatment IndicationMaximum Recommended Dosage
chlordiazepoxideanxietyGreater than or equal to  6 years: 30 mg daily in divided doses
clobazamseizures associated with Lennox-Gastaut syndrome
  • 2 years and older, adolescents less than or equal to 30 kg:
    • 20 mg/day in two divided doses
  • 2 years and older, adolescents greater than 30 kg:
    • 40 mg/day in two divided doses
clonazepamseizures
  • Less than 10 years or less than or equal to 30 kg:
    • 0.2 mg/kg daily in divided doses
  • Greater than or equal to 10 years or greater than  30 kg:
    • 20 mg daily in divided doses
clorazepateseizures
  • 9-12 years: 60 mg daily in divided doses
  • Greater than 12 years: 90 mg daily in divided doses
diazepam (nasal)seizures
  • 6-11 years of age:
    • 10-18 kg: 5 mg as one spray in one nostril (equates to 0.3 mg/kg dose)^
    • 19-37 kg: 10 mg as one spray in one nostril (equates to 0.3 mg/kg dose)^
    • 38-55 kg: 15 mg as 2 x 7.5 mg devices with one spray in each nostril (equates to 0.3 mg/kg dose) ^
    • 56-74 kg: 20 mg as 2 x 10 mg devices with one spray in each nostril (equates to 0.3 mg/kg dose) ^
  • Greater than or equal to 12 years of age:
    • 14-27 kg: 5 mg as one spray in one nostril (equates to 0.2 mg/kg dose)^
    • 28-50 kg: 10 mg as one spray in one nostril (equates to 0.2 mg/kg dose)^
    • 51-75 kg: 15 mg as 2 x 7.5 mg devices with one spray in each nostril (equates to 0.2 mg/kg dose) ^
    • Greater than or equal to 76 kg: 20 mg as 2 x 10 mg devices with one spray in each nostril (equates to 0.2 mg/kg dose) ^
diazepam (oral)musculoskeletal conditionsGreater than or equal to 6 months of age: 10 mg/day in divided doses have been used; dose may be increased as needed and tolerated – no maximum dose documented
diazepam (oral)seizuresGreater than or equal to 6 months of age: 10 mg/day in divided doses have been used; dose may be increased as needed and tolerated – no maximum dose documented
diazepam (rectal)seizures+
  • 2-5 years: 0.5 mg/kg/dose^
  • 6-11 years: 0.3 mg/kg/dose^
  • Greater than or equal to 12 years: 0.2 mg/kg/dose^
lorazepamanxietyGreater than or equal to 12 years: 10 mg daily in divided doses (maximum, 2 mg/dose)
 insomnia due to anxiety or situational stressGreater than or equal to 12 years: 4 mg at bedtime
midazolam (nasal)seizuresGreater than or equal to 12 years: 5 mg as one spray in one nostril!
oxazepamanxiety
  • 6-12 years: dose not established;
    • 1 mg/kg/day in divided doses has been adequate
  • Greater than 12 years:
    • mild, moderate: 60 mg daily, in divided doses
    • severe: 120 mg daily, in divided doses

Legend:

  • ^ May give second diazepam nasal or rectal dose at least 4 hours after first dose, if necessary; may not use more than 2 doses to treat single episode; may not treat more than 1 episode/5 days or more than 5 episodes/month
  • + Dose rounded up to nearest commercially available unit dose (in multiples of 2.5 mg); should not be administered by caregivers outside the hospital more frequently than one course every 5 days with a maximum of 5 courses per month; not for chronic administration to minimize potential for development of tolerance
  • ! May give second midazolam nasal dose 10 minutes after first dose, if necessary; may not use more than 2 doses to treat a single episode. Nasal midazolam should be used to treat no more than one episode every three days and no more than 5 episodes per month