P - Contraindicated in Pregnancy
L - Contraindicated in Lactation
Brotizolam is a sedative-hypnotic thienodiazepine drug which is a benzodiazepine analog. It possesses anxiolytic, anticonvulsant, hypnotic, sedative and skeletal muscle relaxant properties and is considered to be similar in effect to short-acting benzodiazepines such as triazolam. It is used in the short term treatment of severe or debilitating insomnia. Brotizolam is an extremely potent drug and has shown anti-anxiety activity at doses as low as 80 to 100 micrograms, but the usual hypnotic dose of brotizolam is 0.125 to 0.25 milligrams, and it is rapidly eliminated with an average half-life of 4.4 hours (range 3.6 - 7.9 hours).
Brotizolam is a short-acting benzodiazepine with general properties similar to diazepam.
It is used orally in the treatment of Insomnia.
Drowsiness and lightheadedness, sedation, muscle weakness and ataxia; less frequently vertigo, headache, confusion, depression, slurred speech, changes in libido, tremor, visual disturbances, urinary retention, GI disturbances, changes in salivation and amnesia.
Chronic pulmonary insufficiency; elderly or debilitated patients; muscle weakness, impaired liver or kidney function; drowsiness may affect skilled tasks; monitor cardio-respiratory function when used for deep sedation; personality disorders or organic brain changes; history of alcohol or drug addiction. respiratory depression and hypotension with parenteral admin; this route should only be used when facilities for reversing respiratory depression are available. Dependence.
Enhanced sedation or respiratory and cardivascular depression with drugs with CNS depressant properties eg, antidepressants, antihistamines, antipsychotics, general anaesth, other hypnotics or sedatives, opioid analgesics and cisapride. Alcohol. Calcium-channel blockers; clonidine; diaxozide; disulfiram; clozapine; diuretics; moxonidine; nabitone; nitrates; cimetidine, esomeprazole and omeprazole; muscle relaxants; dopaminergics; lofexidine; hydralazine, minoxidil and nitroprusside; antifungals; angiotensin II receptor antagonist; antiepileptics; βeta-blockers; antibacterials.Potentially Fatal: Drugs which alter the hepatic microsomal enzymes.
Preexisting CNS depression or coma, resp depression, acute pulmonary insufficiency or sleep apnoea; severe hepatic impairment; not indicated for chronic psychosis, phobic or obsessional states; may precipitate suicide or aggressive behavior, not used alone to treat depression or anxiety associated with depression; glaucoma. Pregnancy and lactation. Neonates.