Clobazam (marketed under the brand names Frisium, Urbanol, Onfi and Tapclob ) is a benzodiazepine class medication that was patented in 1968[1] and has been marketed as an anxiolytic since 1975[2] and an anticonvulsant since 1984.[3]
Medical uses
Clobazam is used for epilepsy. It is unclear if there are any benefits to clobazam over other seizure medications for children with Rolandic epilepsy or other epileptic syndromes.[4][needs update]
As of 2005, clobazam is approved in Canada for add-on use in tonic-clonic, complex partial, and myoclonic seizures.[5] Clobazam is approved for adjunctive therapy in complex partial seizures[6] certain types of status epilepticus, specifically the myoclonic, myoclonic-absent, simple partial, complex partial, and tonic varieties,[7] and non-status absence seizures. It is also approved for treatment of anxiety. In India, clobazam is approved for use as an adjunctive therapy in epilepsy and in acute and chronic anxiety.[8] In Japan, clobazam is approved for adjunctive therapy in treatment-resistant epilepsy featuring complex partial seizures.[9] In New Zealand, clobazam is marketed as Frisium[10] In the United Kingdom clobazam (Frisium) is approved for short-term (2–4 weeks) relief of acute anxiety in patients who have not responded to other drugs, with or without insomnia and without uncontrolled clinical depression.[11] It was not approved in the US until October 25, 2011, when it was approved for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients 2 years of age or older.[12]
It is also approved for adjunctive therapy for epilepsy in patients who have not responded to first-line drugs and in children who are refractory to first-line drugs. It is not recommended for use in children between the ages of six months and three years, unless there is a compelling need.[11] In addition to epilepsy and severe anxiety, clobazam is also approved as a short-term (2–4 weeks) adjunctive agent in schizophrenia and other psychotic disorders to manage anxiety or agitation.[11]
Clobazam is also available as an oral suspension in the UK, under the trade name of Tapclob.
Clobazam is sometimes used for refractory epilepsies. However, long-term prophylactic treatment of epilepsy has considerable drawbacks, most importantly loss of antiepileptic effects due to tolerance which may render long-term therapy ineffective.[13] Other antiepileptic drugs may therefore be preferred for the long-term management of epilepsy. Furthermore, benzodiazepines have the drawback, particularly after long-term use, of causing rebound seizures upon abrupt or over-rapid discontinuation of therapy forming part of the benzodiazepine withdrawal syndrome.
Contraindications
Clobazam should be used with great care in patients with the following disorders:
Myasthenia gravis
Sleep apnea
Severe liver diseases such as cirrhosis and hepatitis[14]
Severe Respiratory Insufficiency
Benzodiazepines require special precaution if used in the elderly, during pregnancy, in children, alcohol or drug-dependent individuals and individuals with comorbid psychiatric disorders.[15]
Overdose
Overdose and intoxication with benzodiazepines, including clobazam, may lead to CNS depression, associated with drowsiness, confusion, and lethargy, possibly progressing to ataxia, respiratory depression, hypotension and rarely coma or death. The risk of a fatal outcome is increased in cases of combined poisoning with other CNS depressants, including alcohol.[18]
