Clobazam

Source: UK SPC (Clobazam 10 mg Tablets, eMC) §4.2. Other indication — anxiety: the usual anxiolytic dose for adults is 20–30 mg daily in divided doses or as a single dose given at night; the lowest dose that controls symptoms should be used and the dose may be reduced after improvement. Anxiolytic use should not exceed 4 weeks and long-term chronic use as an anxiolytic is not recommended; extension beyond the maximum treatment period requires re-evaluation with special expertise. If used for epilepsy, it should be used for as long as the prescriber considers necessary. Elderly: 10–20 mg daily in anxiety may be used, as the elderly are more sensitive to psychoactive agents; treatment requires low initial doses and gradual dose increments under careful observation. Re-assess the patient after a period not exceeding 4 weeks and regularly thereafter. Withdraw gradually — risk of withdrawal/rebound phenomena is greater after abrupt discontinuation; patients treated long term may need a longer reduction period. Discuss an exit strategy with the patient before starting, to minimise the risk of dependence, addiction and withdrawal syndrome. A break in therapy may be beneficial if drug exhaustion develops, recommencing at a low dose. Note on interactions: eMC §4.5 was not included in the fetched bundle, so the interactions listed below are taken from the US label §7 and must be checked against UK SPC §4.5 before publication. US labelling (oral suspension, Ascend Laboratories, label date 2026-07-09) differs from the UK SPC and dose by body-weight group instead: ≤30 kg — start 5 mg daily, day 7 10 mg daily, day 14 20 mg daily; >30 kg — start 10 mg daily, day 7 20 mg daily, day 14 40 mg daily; daily doses above 5 mg in two divided doses; do not escalate more rapidly than weekly. US label also gives reduced/slower titration (half the table dose, 5 mg/day start) for elderly patients, CYP2C19 poor metabolisers and mild-to-moderate hepatic impairment (Child-Pugh 5–9), with no recommendation in severe hepatic impairment.

eMC §4.2, paediatric patients aged 6 years and above: treatment requires low initial doses and gradual dose increments under careful observation; it is recommended that normally treatment should be started at 5 mg daily, and a maintenance dose of 0.3–1 mg/kg body weight daily is usually sufficient. As there is no age-appropriate formulation to enable safe and accurate dosing, no dosage recommendations can be made in children under 6 years of age. §4.3 adds that clobazam must not be used in children between the ages of 6 months and 3 years other than in exceptional cases for anticonvulsant treatment where there is a compelling indication, and that benzodiazepines must not be given to children without careful assessment of the need for their use. The maintenance figure is a range, so no single dosePerKg value can be recorded — clinician to verify the paediatric regimen against a children's formulary before publication.