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.
Drug Name | Treatment Indication | Maximum Recommended Dosage |
---|---|---|
chlordiazepoxide | anxiety | Greater than or equal to 6 years: 30 mg daily in divided doses |
clobazam | seizures associated with Lennox-Gastaut syndrome |
|
clonazepam | seizures |
|
clorazepate | seizures |
|
diazepam (nasal) | seizures |
|
diazepam (oral) | musculoskeletal conditions | Greater 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) | seizures | Greater 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+ |
|
lorazepam | anxiety | Greater than or equal to 12 years: 10 mg daily in divided doses (maximum, 2 mg/dose) |
insomnia due to anxiety or situational stress | Greater than or equal to 12 years: 4 mg at bedtime | |
midazolam (nasal) | seizures | Greater than or equal to 12 years: 5 mg as one spray in one nostril! |
oxazepam | anxiety |
|
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