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.