Formulary
Clobazam: Indications, Dosing, Side Effects and Interactions
Clobazam clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 6 min read
Clobazam: Indications, Dosing, Side Effects and Interactions
Clobazam clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Adjunct in epilepsy**
- **Child** (By Mouth): 6-17 years Initially 5 mg daily, dose to be increased if necessary at intervals of 5 days, maintenance 0.3-1 mg/kg daily, daily doses of up to 30 mg may be given as a single dose at bedtime, higher doses should be divided; maximum 60 mg per day.
- **Adult** (By Mouth): 20-30 mg daily, then increased if necessary up to 60 mg daily.
**Anxiety (short-term use)**
- **Adult** (By Mouth): 20-30 mg daily in divided doses, alternatively 20-30 mg once daily, dose to be taken at bedtime; increased if necessary up to 60 mg daily in divided doses, dose only increased in severe anxiety (in hospital patients), for debilitated patients, use elderly dose.
- **Elderly** (By Mouth): 10-20 mg daily.
**Adjunct in epilepsy for clobazam**
- **Child 1 month-5 years** (By mouth): Initially 125 micrograms/kg twice daily, dose to be increased if necessary every 5 days, maintenance 250 micrograms/kg twice daily (max. per dose 500 micrograms/kg twice daily); maximum 30 mg per day.
- **Child 6-17 years** (By mouth): Initially 5 mg daily, dose to be increased if necessary at intervals of 5 days, maintenance 0.3-1 mg/kg daily, daily doses of up to 30 mg may be given as a single dose at bedtime, higher doses should be divided; maximum 60 mg per day.
**Monotherapy for catamenial (menstruation) seizures (usually for 7-10 days each month, just before and during menstruation) (under expert supervision), Cluster seizures for clobazam**
- **Child 1 month-5 years** (By mouth): Initially 125 micrograms/kg twice daily, dose to be increased if necessary every 5 days, maintenance 250 micrograms/kg twice daily (max. per dose 500 micrograms/kg twice daily); maximum 30 mg per day.
- **Child 6-17 years** (By mouth): Initially 5 mg daily, dose to be increased if necessary at intervals of 5 days, maintenance 0.3-1 mg/kg daily, daily doses of up to 30 mg may be given as a single dose at bedtime, higher doses should be divided; maximum 60 mg per day.
Cautions
Avoid prolonged use (and abrupt withdrawal thereafter); debilitated patients (reduce dose) (in adults); elderly (reduce dose) (in adults); history of alcohol dependence or abuse; history of drug dependence or abuse; myasthenia gravis; personality disorder (within the fearful group-dependent, avoidant, obsessive-compulsive) may increase risk of dependence; respiratory disease Cautions, further information Paradoxical effects A paradoxical increase in hostility and aggression may be reported by patients taking benzodiazepines. The effects range from talkativeness and excitement to aggressive and antisocial acts. Adjustment of the dose (up or down) sometimes attenuates the impulses. Increased anxiety and perceptual disorders are other paradoxical effects. Elderly In adults: Screening Tool of Older Persons' potentially inappropriate Prescriptions (STOPP) criteria to aid medication reviews (see Prescribing in the elderly for information). Potentially inappropriate: for a duration of 4 weeks or longer (no indication for longer treatment; risk of adverse events; all benzodiazepines should be withdrawn gradually if taken for more than 2 weeks as there is a risk of causing a benzodiazepine withdrawal syndrome if stopped abruptly) with acute or chronic respiratory failure i.e. PaO 2 < 8 kPa with or without PaCO 2 > 6.5 kPa (risk of exacerbation of respiratory failure) in patients prone to falls (sedative, may cause reduced sensorium and impair balance) Cautions For clobazam Muscle weakness; organic brain changes Cautions, further information The effectiveness of clobazam may decrease significantly after weeks or months of continuous therapy.
Contraindications
Acute pulmonary insufficiency; marked neuromuscular respiratory weakness; not for use alone to treat chronic psychosis (in adults); not for use alone to treat depression (or anxiety associated with depression) (in adults); obsessional states; phobic states; sleep apnoea syndrome; unstable myasthenia gravis Contra-indications For clobazam Respiratory depression
Side effects
Common or very common Alertness decreased; anxiety; ataxia (more common in elderly); confusion (more common in elderly); depression; dizziness; drowsiness; dysarthria; fatigue; headache; hypotension; mood altered; muscle weakness; nausea; respiratory depression (particularly with high dose and intravenous use-facilities for its treatment are essential); sleep disorders; tremor; vision disorders; withdrawal syndrome Uncommon Agitation (more common in children and elderly); anterograde amnesia; behaviour abnormal; hallucination; libido disorder; rash Rare or very rare Aggression (more common in children and elderly); blood disorder; delusions; jaundice; paradoxical drug reaction; restlessness (with sedative and peri-operative use); urinary retention Frequency not known Drug dependence Overdose Benzodiazepines taken alone cause drowsiness, ataxia, dysarthria, nystagmus, and occasionally respiratory depression, and coma. For details on the management of poisoning, see Benzodiazepines, under Emergency treatment of poisoning . Side-effects For clobazam Frequency not known Appetite decreased; consciousness impaired; constipation; dry mouth; fall; gait unsteady; libido loss; movement disorders; muscle spasms; nystagmus; psychotic disorder; respiratory disorder; severe cutaneous adverse reactions (SCARs); skin reactions; speech impairment; suicidal behaviours; weight increased
Interactions
**Other interactions (19):**
- Alcohol Concomitant consumption of alcohol can increase the bioavailability of clobazam by 50% (see section 5.2) and therefore increase the effects of clobazam e.g.
- Central nervous system depressant drugs Especially when clobazam is administered at higher doses, an enhancement of the central depressive effect may occur in cases of concomitant use with...
- Special caution is also necessary when clobazam is administered in cases of intoxication with such substances or with lithium.
- Opioids The concomitant use of benzodiazepines, including clobazam, and opioids increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect.
- Limit dosage and duration of concomitant use of benzodiazepines and opioids (see section 4.4).
- Anticonvulsants Addition of clobazam to established anticonvulsant medication (e.g.
Pregnancy
Important safety information For clobazam Safe practice Clobazam has been confused with clonazepam; care must be taken to ensure the correct drug is prescribed and dispensed. MHRA/CHM advice: Antiepileptics: risk of suicidal thoughts and behaviour (August 2008) See Epilepsy . MHRA/CHM advice: Antiepileptic drugs: updated advice on switching between different manufacturers' products (November 2017) See Epilepsy and see also Prescribing and dispensing information . MHRA/CHM advice: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review (January 2021) See Epilepsy .
Breast feeding
Benzodiazepines are present in milk, and should be avoided if possible during breast-feeding. Monitoring in breast feeding All infants should be monitored for sedation, feeding difficulties, adequate weight gain, and developmental milestones.
Hepatic impairment
In general, manufacturers advise caution in mild to moderate impairment; avoid in severe impairment. Benzodiazepines with a shorter half-life are considered safer. Dose adjustments In general, manufacturers advise dose reduction in mild to moderate impairment, adjust dose according to response.
Renal impairment
In general, manufacturers advise caution (risk of increased cerebral sensitivity to benzodiazepines). Dose adjustments In general, manufacturers advise to consider dose reduction.
Medicinal forms
Capsule,Tablet,Suspension
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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