ZOLPIDEM

4). Treatment should be given for the shortest possible duration. The treatment should be taken in a single intake and not be re-administered during the same night. The recommended daily dose for adults is 10 mg to be taken immediately at bedtime.

The lowest effective daily dose of zolpidem should be used and must not exceed 10 mg. The duration of treatment should usually vary from a few days to two weeks with a maximum of four weeks including tapering off where clinically appropriate.

Treatment should be as short as possible. It should not exceed four weeks including the period of tapering off. 4). Special Populations Paediatric population Zolpidem is not recommended for use in children and adolescents below 18 years of age, due to a lack of data to support use in this age group.

1. Elderly Elderly or debilitated patients may be especially sensitive to the effects of zolpidem, in these subjects a 5 mg dose is recommended. These recommended doses should not exceed 10 mg in this population. 3). Mild to Moderate Hepatic Impairment As clearance and metabolism of zolpidem tartrate is reduced in hepatic impairment, dosage should begin at 5 mg in these patients with particular caution being exercised in elderly patients.

In adults (under 65 years) dosage may be increased to 10 mg only where the clinical response is inadequate and the drug is well tolerated. Method of administration For oral use. Zolpidem tartrate acts rapidly and therefore should be taken immediately before retiring, or in bed.

The following CIOMS frequency rating is used, when applicable:

Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1 000 to < 1/100) Rare (≥ 1/10 000 to < 1/1 000) Very rare (< 1/10 000) Not known (cannot be estimated based on available data). There is evidence of a dose-relationship for adverse effects associated with zolpidem use, particularly for certain CNS events.

2, they should, in theory, be less if zolpidem is taken immediately before retiring, or in bed. They occur most frequently in elderly patients. Nervous system disorders Common: somnolence, headache, dizziness, exacerbated insomnia, cognitive disorders such as memory disorders (memory impairment, amnesia, anterograde amnesia).

Uncommon: paraesthesia, tremor, disturbance in attention, speech disorder; Rare: depressed level of consciousness. 4). Most of these psychiatric undesirable effects are related to paradoxical reactions. 4); Not known: drug tolerance, withdrawal syndrome.

4). Withdrawal symptoms vary and may include rebound insomnia, muscle pain, anxiety, tremor, sweating, agitation, confusion, headache, palpitations, tachycardia, delirium, nightmares, hallucinations, panic attacks, muscle aches/cramps, gastrointestinal disturbances 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. In very rare cases, seizures may occur.

Eye disorders Uncommon: diplopia, vision blurred; Rare: visual impairment. 4). Gastro-intestinal Disorders Common: diarrhoea, nausea, vomiting, abdominal pain. Musculoskeletal and connective tissue disorders Common: back pain; Uncommon: arthralgia, myalgia, muscle spasms, neck pain, muscular weakness.

Infections and infestations Common: upper respiratory tract infection, lower respiratory tract infection. Skin and subcutaneous tissue disorders Uncommon: rash, pruritus, hyperhidrosis; Rare: urticaria. 5). Immune system disorders Not known: angioneurotic oedema.

Metabolism and nutrition disorders Uncommon: appetite disorder. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.

Warnings:

Zolpidem should be used with caution in patients with sleep apnoea syndrome, and myasthenia gravis. • Respiratory insufficiency As hypnotics have the capacity to depress respiratory drive precautions should be observed if zolpidem is prescribed to patients with compromised respiratory function.

• Risk from concomitant use of opioids Concomitant use of zolpidem and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs such as zolpidem with opioids should be reserved for patients for whom alternative treatment options are not possible.

2). The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). 8). • Drug dependence, tolerance and potential for abuse Use of zolpidem may lead to the development of abuse and/or physical and psychological dependence.

Drug addiction comprises behavioural, cognitive and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use and possible tolerance or physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, which manifests as withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.

Addiction and dependence are related but distinct presentations and in discussing these themes, terminology that apportion blame to the individual should be avoided. For all patients, prolonged use of this product may lead to drug dependence and addiction, but can occur with short-term use at recommended therapeutic doses.

, major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of drug misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on- line, and past and present medical and psychiatric conditions.

Tolerance Some loss of efficacy to the hypnotic effects of sedative/hypnotic agents like zolpidem may develop after repeated use for a few weeks. Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of symptom control as initially experienced.

Patients may also supplement their treatment with additional medications to achieve the same effect. These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient.

Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else. Patients should be closely monitored for signs of misuse, abuse, or addiction.

The clinical need for treatment with zolpidem tartrate should be reviewed regularly, with frequent assessments of patients being undertaken during the course of their treatment. Drug withdrawal syndrome Prior to starting treatment with zolpidem tartrate, a discussion should be held with patients to explain the risk of dependence, addiction, and drug withdrawal syndrome.

A withdrawal strategy for ending treatment with zolpidem tartrate should also be put in place with the patient before starting treatment (there may be exceptions to this in specific clinical situations such as symptom management in end of life palliative care).

Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. 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.

When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take in excess of weeks or months. Patients should be informed of this when the medication is first prescribed.

The reduction schedule for a patient should be tailored to the individual and should be modified to allow intolerable withdrawal symptoms to improve before making the next reduction. If using a published withdrawal schedule, apply it flexibly to accommodate the person’s preferences, changes to their circumstances and the response to dose reductions.

A slow stepwise rate of reduction proportionate to the existing dose should be suggested, so that decrements become smaller as the dose is lowered, unless clinical risk is such that rapid withdrawal is needed.

Precautions:

The cause of insomnia should be identified wherever possible and the underlying factors treated before a hypnotic is prescribed. The failure of insomnia to remit after a 7-14 day course of treatment may indicate the presence of a primary psychiatric or physical disorder, and the patient should be carefully re-evaluated at regular intervals.

Specific patient groups • Elderly See dose recommendations. Due […]

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