APO-ZOLPIDEM

What it is

APO-ZOLPIDEM contains zolpidem tartrate 5 mg or 10 mg per tablet. Zolpidem belongs to the imidazopyridine group of compounds and selectively binds the omega-1 receptor subtype of the GABA-A receptor complex.

Approved indications

— Short-term treatment of insomnia in adults

Dosing overview

The recommended daily dose for adults is 10 mg, and the lowest effective daily dose should be used and not exceed 10 mg. For elderly or debilitated patients, the recommended daily dose is 5 mg. For patients with hepatic impairment, the recommended daily dose is 5 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 and caution is needed with other CNS depressant drugs. Use should be limited to four weeks maximum under close medical supervision. 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. Elderly and debilitated patients may be particularly susceptible to the sedative effects of the medication and associated giddiness, ataxias and confusion, which may increase the possibility of a fall. Use of zolpidem may lead to the development of abuse and/or physical and psychological dependence, with the risk increasing with dose and duration of treatment and being 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 such as headaches or muscle pain, extreme anxiety and tension, restlessness, confusion and irritability, and in severe cases 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.

Contraindications

APO-ZOLPIDEM 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; use in children under 18 years of age; and in patients who have previously experienced complex sleep behaviours after taking the medicine.

Regulatory history

APO-ZOLPIDEM 5 mg and 10 mg tablets were first listed on the ARTG on 17 July 2007.