ALODORM

What it is

ALODORM is a nitrazepam tablet containing 5 mg of nitrazepam as the active ingredient. Nitrazepam is a member of the group of benzodiazepine agonists and exhibits sedative, anxiolytic, anticonvulsant and muscle relaxant effects. This is presumed to be the result of facilitating the action in the brain of gamma-aminobutyric acid (GABA), an endogenous inhibitor neurotransmitter.

Approved indications

— Insomnia, organic and inorganic in origin.

Dosing overview

For adults, the dose is 1 to 2 tablets (5 to 10 mg) before retiring. This average dosage may be increased if necessary, up to 20 mg for in-patients. Elderly patients should receive ½ to 1 tablet. ALODORM is not approved for use as a hypnotic in children.

Key safety warnings

Although hypotension has occurred only rarely, ALODORM should be administered with caution to patients in whom a drop in blood pressure might lead to cardiac or cerebral complications, particularly in elderly patients. Transient amnesia or memory impairment has been reported in association with the use of benzodiazepines. The use of benzodiazepines may lead to dependence, as defined by the presence of a withdrawal syndrome on discontinuation of the drug, although tolerance seldom occurs in patients receiving recommended doses under medical supervision. In general, benzodiazepines should be prescribed for short periods only (e.g. 2 to 4 weeks), and continuous long-term use of ALODORM is not recommended. ALODORM should be terminated by tapering the dose to minimise occurrence of withdrawal symptoms. Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, and if angioedema involves these structures, airway obstruction may occur and be fatal. Concomitant use of nitrazepam and opioids may result in sedation, respiratory depression, coma and death; concomitant prescribing should be reserved for patients for whom alternative treatment options are not possible, using the lowest effective dose for the shortest possible duration.

Contraindications

ALODORM is contraindicated in patients with known hypersensitivity to benzodiazepines. ALODORM is contraindicated in patients with chronic obstructive airway disease with incipient respiratory failure. ALODORM is contraindicated in severe liver insufficiency.

PBS listing

ALODORM 5 mg tablets are listed on the PBS with 4 items, requiring authority, at an ex-manufacturer price of A$2.50.

Regulatory history

ALODORM nitrazepam 5 mg tablets were first registered on the Australian Register of Therapeutic Goods on 14 November 1995 under ARTG number 54009.