HYPNOVEL

What it is

Hypnovel is a solution for injection containing midazolam. It is available in three formulations: Hypnovel 5 mg in 5 mL (1 mg/mL), Hypnovel 5 mg in 1 mL (5 mg/mL), and Hypnovel 15 mg in 3 mL (5 mg/mL). The solution is clear and colourless. Hypnovel is a benzodiazepine from the imidazobenzodiazepine group. It is a short-acting central nervous system depressant which induces sedation, hypnosis, amnesia and anaesthesia.

Approved indications

— Intravenous use as an agent for conscious sedation prior to short surgical, diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography and cardiac catheterisation, either alone or in conjunction with a narcotic. — Intravenous use for induction of anaesthesia, preliminary to administration of other anaesthetic agents. — Intravenous use for sedation in intensive care units; intermittent administration or continuous infusion. — Intramuscular use for preoperative sedation (induction of sleepiness or drowsiness and relief of apprehension) and to impair memory of perioperative events.

Dosing overview

Dosage should be individualised and the drug should be administered slowly. Lower doses may be required in elderly or debilitated patients or in patients with hepatic or renal insufficiency.

Key safety warnings

Serious and life-threatening cardiorespiratory adverse events have been reported with Hypnovel injection. Provision for monitoring, detection and correction of these reactions must be made for every patient regardless of age or health status. Intravenous Hypnovel should only be used in settings with equipment and skilled personnel for continuous monitoring of cardiorespiratory function and resuscitation procedures. Patients should be continuously monitored for early signs of under-ventilation or apnoea. During intravenous application of Hypnovel, respiratory depression, apnoea, respiratory arrest and cardiac arrest have occurred. In some cases where this was not recognised promptly and treated, hypoxic encephalopathy or death has resulted. These life-threatening incidents may occur, especially if the injection is given too rapidly or with excessive doses. Particular care must be used in administering Hypnovel intravenously to the elderly, very ill patients, high risk surgical patients and those with significant hepatic impairment, chronic renal insufficiency, congestive heart failure, or with limited pulmonary reserve. These patients require lower doses whether premedicated or not. Patients with chronic obstructive pulmonary disease are unusually sensitive to the respiratory depressant effect of Hypnovel. After prolonged intravenous administration of Hypnovel, abrupt discontinuation may be accompanied by withdrawal symptoms including headaches, diarrhoea, muscle pain, extreme anxiety, tension, sleep disturbances, restlessness, confusion, irritability, mood changes, hallucinations and convulsions. A gradual reduction of Hypnovel is recommended. Concomitant use of barbiturates, alcohol or other central nervous system depressants increases the risk of under-ventilation or apnoea and cardioventricular depression and may contribute to a profound and prolonged drug effect that could result in coma or death.

Contraindications

Hypnovel should not be used in patients with myasthenia gravis or those with hypersensitivity to benzodiazepines or any of their formulation excipients. Hypnovel should not be administered to patients in shock or coma, or in acute alcoholic intoxication with depression of vital signs. Benzodiazepines are contraindicated in patients with acute narrow angle glaucoma.

Regulatory history

Hypnovel received initial approval on 23 August 1991. Three strength variants are registered on the ARTG: Hypnovel 15 mg/3 mL (ARTG 13727), Hypnovel 5 mg/5 mL (ARTG 13779), and Hypnovel 5 mg/1 mL (ARTG 13726), all first listed on 23 August 1991.