1.1. Adults
Non-sedative/hypnotic benzodiazepines and benzodiazepines with mixed indications are FDA-approved for use in the outpatient setting to manage anxiety (alprazolam, chlordiazepoxide, clorazepate, oral diazepam, lorazepam, oxazepam), panic disorder (alprazolam, clonazepam), acute musculoskeletal (MS) conditions including spasticity (oral diazepam), seizures [clobazam (Lennox-Gastaut syndrome), clonazepam, clorazepate, nasal, oral and rectal diazepam], and acute alcohol withdrawal (chlordiazepoxide, clorazepate, oral diazepam, oxazepam) 1-11. An oral film formulation of clobazam (Sympazan®) is FDA approved for adjunctive seizure management in Lennox-Gastaut syndrome 1,2,12. A diazepam nasal formulation (Valtoco®) is FDA-approved to treat intermittent frequent seizure episodes that differ from a patient’s usual seizure pattern 1,2,13. Nayzilam® is a nasal spray formulation of midazolam that is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in patients with epilepsy 1,2,14. In November 2021, the FDA approved a once daily extended release formulation of lorazepam (Loreev XR®) that is approved for the treatment of anxiety disorders in adults who are already receiving three times daily dosing of lorazepam 1,2,15.
The chlordiazepoxide-amitriptyline combination is indicated for depression with associated anxiety symptoms, while chlordiazepoxide/clidinium is FDA-approved to control emotional and somatic factors in gastrointestinal disorders as well as adjunctive use in peptic ulcer disease, irritable bowel syndrome, and acute enterocolitis 1,2,16. Tables 1 1-15 and 2 1,2,16,17summarize the adult maximum recommended dosages for non-sedative/hypnotic benzodiazepines as monotherapy and combination therapy.