STILNOX

What it is

STILNOX CR is a modified release tablet containing zolpidem tartrate 6.25 mg or 12.5 mg. Zolpidem belongs to the imidazopyridine group of compounds and selectively binds the omega-1 receptor subtype (also known as the benzodiazepine-1 subtype) which is the alpha unit of the GABA-A receptor complex.

Approved indications

— Short-term treatment of insomnia in adults.

Dosing overview

The recommended daily dose for adults is 12.5 mg, which is the lowest effective daily dose and should not be exceeded. Elderly or debilitated patients may be especially sensitive to the effects of zolpidem, and the recommended daily dose is 6.25 mg. In patients with hepatic impairment, the recommended daily dose is 6.25 mg and these patients should be closely monitored. No dosage adjustment is necessary in patients with renal impairment, although they should be closely monitored.

Key safety warnings

Zolpidem may be associated with potentially dangerous complex sleep-related behaviours which may include sleep walking, sleep driving and other bizarre behaviours. Zolpidem is not to be taken with alcohol. Use should be limited to four weeks maximum under close medical supervision. Complex sleep behaviours, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake, may occur following the first or any subsequent use of STILNOX CR. Patients can be seriously injured or injure others during complex sleep behaviours, and such injuries may result in a fatal outcome. Postmarketing reports have shown that complex sleep behaviours may occur with STILNOX CR alone at recommended doses, with or without the concomitant use of alcohol or other central nervous system (CNS) depressants. Use of zolpidem may lead to the development of abuse and/or physical and psychological dependence. The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a history of psychiatric disorders and/or alcohol or drug abuse. Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headaches or muscle pain, extreme anxiety and tension, restlessness, confusion and irritability. In severe cases derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations, delirium or epileptic seizures may occur. Due to its pharmacological properties, zolpidem can cause drowsiness and a decreased level of consciousness, which may lead to falls and consequently to severe injuries. Patients should not drive or operate machinery for 8 hours after taking STILNOX CR.

Contraindications

STILNOX CR is contraindicated in sleep apnoea, known hypersensitivity to zolpidem or other ingredients in the tablet, myasthenia gravis, severe hepatic insufficiency, acute and/or severe pulmonary insufficiency, prior or concomitant intake with alcohol, in children under 18 years of age, and in patients who have previously experienced complex sleep behaviours after taking STILNOX CR.

PBS listing

Information on PBS listing is not provided in the source documents.

Regulatory history

STILNOX CR 6.25 mg modified release tablet was first listed on the ARTG on 6 July 2006, and STILNOX CR 12.5 mg modified release tablet was first listed on 6 July 2006.