TEMTABS

What it is

TEMTABS contains temazepam 10 mg as the active ingredient. TEMTABS 10 mg are white to off-white, round, biconvex tablets, with stylised "S" on one side and plain on the other side.

Approved indications

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

Dosing overview

Dosage should be individualised for maximum beneficial effect. 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 TEMTABS is the initial recommended dosage. TEMTABS is not recommended for children.

Key safety warnings

Use of benzodiazepines, including temazepam, may lead to potentially fatal respiratory depression. Caution in the use of TEMTABS is recommended in patients with respiratory depression. Although hypotension has occurred rarely, TEMTABS should be administered with caution to patients in whom a drop in blood pressure might lead to cardiac or cerebral complications. This is particularly important in elderly patients. The use of benzodiazepines, including temazepam, may lead to physical and psychological dependence as defined by the presence of a withdrawal syndrome on discontinuation of the drug. The risk of dependence increases with higher doses and longer term use and is further increased in patients with a history of alcoholism or drug abuse or in patients with significant personality disorders. In general, benzodiazepines should be prescribed for short periods only (e.g. 2–4 weeks). Continuous long-term use of TEMTABS is not recommended. Complex behaviours such as "sleep-driving" (i.e. driving while not fully awake after taking a sedative-hypnotics, with amnesia for the event) have been reported with sedative hypnotics. These events can occur in sedative-hypnotics naïve as well as in sedative hypnotic experienced persons. These events can occur at normal therapeutic doses, and the risk appears 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 the first or subsequent doses of sedative-hypnotics. These cases of angioedema may cause airway obstruction and be fatal; this has required medical therapy in emergency departments for some patients. The concomitant use of temazepam with alcohol or/and CNS depressants should be avoided. Such concomitant use has the potential to increase the clinical effects of temazepam which may include severe sedation, clinically relevant respiratory and/or cardio-vascular depression.

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.

PBS listing

TEMTABS 10 mg is listed on the PBS with 4 items, restricted with authority required, at an ex-manufacturer price of A$2.50.

Regulatory history

TEMTABS temazepam 10 mg tablet blister pack was first listed on the ARTG on 23 September 2002.