ZOLPIDEM-WGR

What it is

ZOLPIDEM-WGR contains zolpidem, which belongs to the imidazopyridine group of compounds and is structurally unrelated to other hypnotic agents. Zolpidem 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. Each tablet contains zolpidem tartrate 5 mg or 10 mg.

Approved indications

— Short-term treatment of insomnia in adults.

Dosing overview

The recommended daily dose for adults is 5 mg or 10 mg. Treatment should be as short as possible and should not exceed four weeks. ZOLPIDEM-WGR should be taken immediately before retiring or in bed, in a single intake and not re-administered during the same night.

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. 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. Patients can be seriously injured or injure others during complex sleep behaviours. Such injuries may result in a fatal outcome. Zolpidem can cause drowsiness and a decreased level of consciousness, which may lead to falls and consequently to severe injuries. Several epidemiological studies show an increased incidence of suicide and suicide attempt in patients with or without depression, treated with benzodiazepines and other hypnotics, including zolpidem. 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 the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations, delirium or epileptic seizures. Concomitant use of sedative-hypnotic drugs, including zolpidem, with opioids may result in sedation, respiratory depression, coma and death. Reserve concomitant prescribing of opioids and zolpidem for use in patients for whom alternative treatment options are inadequate. If a decision is made to prescribe zolpidem concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation.

Contraindications

ZOLPIDEM-WGR is contraindicated in patients with sleep apnoea, known hypersensitivity to zolpidem or other ingredients in the tablet, myasthenia gravis, severe hepatic insufficiency, acute and/or severe pulmonary insufficiency, and prior or concomitant intake with alcohol. ZOLPIDEM-WGR should not be prescribed for patients who have previously experienced complex sleep behaviours after taking zolpidem.

Regulatory history

ZOLPIDEM-WGR was first listed on the ARTG on 17 July 2007 with two registered variants: the 5 mg tablet blister pack (ARTG 127149) and the 10 mg tablet blister pack (ARTG 127172).