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 established.1-3,16,17 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 age .1,2,14,15.
The oral tablet and oral film formulations of clobazam are approved for use in children 2 years of age and older to manage seizures associated with Lennox-Gastaut syndrome.1,2,11,12 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 pattern .1,2,13.
Except for alprazolam, non-sedative/hypnotic benzodiazepines are indicated for use in pediatric patients to manage anxiety or seizures.1-15 Pediatric dosages and age limitations for benzodiazepines are summarized in Table 3 1,2,4-14.
Table 3. Pediatric Benzodiazepine Maximum Recommended Dosages
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