NORMISON

What it is

Normison contains temazepam. The tablet formulation contains temazepam 10 mg as the active ingredient. The 10 mg tablets are white to off-white, round, biconvex tablets.

Approved indications

— Adjunctive therapy in the short term management of insomnia in adults.

Dosing overview

For use as a hypnotic, the usual adult dose is 10–30 mg taken one-half hour before retiring. In elderly or debilitated patients, 10 mg is the initial recommended dosage. Normison is not recommended for children.

Key safety warnings

Use of benzodiazepines, including temazepam, may lead to potentially fatal respiratory depression, and caution is recommended in patients with respiratory depression. The use of benzodiazepines, including temazepam, may lead to physical and psychological dependence, with the risk of dependence increasing with higher doses and longer term use and further increased in patients with a history of alcoholism or drug abuse or significant personality disorders. Benzodiazepines should be prescribed for short periods only (for example, 2–4 weeks), and continuous long-term use of Normison is not recommended. Complex behaviours such as "sleep-driving" have been reported with sedative hypnotics, and these events can occur at normal therapeutic doses, with the risk appearing to be increased when sedative-hypnotics are combined with alcohol or other CNS depressants or used at doses exceeding the maximum recommended dose. Angioedema involving the tongue, glottis and larynx has been reported in some patients after taking sedative-hypnotics, and these cases may cause airway obstruction and be fatal. The concomitant use of temazepam with alcohol or CNS depressants should be avoided, as such concomitant use has the potential to increase the clinical effects of temazepam which may include severe sedation and clinically relevant respiratory and/or cardiovascular depression. Elderly or debilitated patients may be particularly susceptible to the sedative effects of benzodiazepines and associated giddiness, ataxia and confusion, which may increase the possibility of a fall.

Contraindications

Patients with a known hypersensitivity to benzodiazepines or to any of the formulation. Patients with chronic obstructive airways disease with incipient respiratory failure. Patients with sleep apnoea. Temazepam should not be used as monotherapy to treat depression, or symptoms of anxiety associated with depression, due to a risk of suicide.

Regulatory history

Normison temazepam 10 mg tablet was first listed on the ARTG on 30 September 1992.