ZOLPIDEM TARTRATE

4). Treatment should be given for the shortest possible duration. Posology 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. As with all hypnotics, long-term use is not recommended. Treatment should be as short as possible and 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 therefore a 5 mg dose is recommended.

These recommended doses should not be exceeded. Hepatic impairment As clearance and metabolism of zolpidem 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. 3). Method of administration Oral administration.

01% 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 and gastrointestinal 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. 4). Not known: anger, psychosis, abnormal behaviour Most of these psychiatric undesirable effects are related to paradoxical reactions. 4) Metabolism and nutrition disorders Uncommon: appetite disorder Skin and subcutaneous tissue disorders Uncommon: rash, pruritus, hyperhidrosis Rare: urticaria Musculoskeletal and connective tissue disorders Common: back pain Uncommon: myalgia, muscle spasms, muscular weakness Infections and infestations Common: upper respiratory tract infection, lower respiratory tract infection General disorders and administration site conditions Common: fatigue Rare: gait disturbance, fall (predominantly in elderly patients and when zolpidem was not taken in accordance with prescribing recommendation) 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.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

Next–day psychomotor impairment Like other sedative/hypnotic drugs, zolpidem has CNS-depressant effects. 5). Zolpidem should be taken in a single intake immediately at bedtime and not be re- administered during the same night.

Specific patient groups 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. 2. 2 for dose recommendations.

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).

Use in patients with a history of drug or alcohol abuse:

Extreme caution should be exercised when prescribing for patients with a history of drug or alcohol abuse. These patients should be under careful surveillance when receiving zolpidem tartrate or any other hypnotic, since they are at risk of habituation and psychological dependence.

Psychotic illness:

Hypnotics such as zolpidem are not recommended for the primary treatment of psychotic illness.

Suicidal ideation/suicide attempt/suicide and depression:

Some epidemiological studies suggest an increased incidence of suicidal ideation, suicide attempt and suicide in patients with or without depression, and treated with benzodiazepines and other hypnotics, including zolpidem.

However, a causal relationship has not been established:

As with other sedative/hypnotic drugs, zolpidem should be administered with caution in patients exhibiting symptoms of depression. Suicidal tendencies may be present therefore the least amount of zolpidem that is feasible should be supplied to these patients to avoid the possibility of intentional overdose by the patient.

Pre-existing depression may be unmasked during use of zolpidem. Since insomnia may be a symptom of depression, the patient should be re-evaluated if insomnia persists. General information relating to effects seen following administration of benzodiazepines and other hypnotic agents which should be taken into account by the prescribing physician are described below.

Tolerance:

Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines and benzodiazepine-like agents like zolpidem may develop after repeated use for a few weeks. Drug dependence, tolerance and potential for abuse 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.

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 should be reviewed regularly, with frequent assessments of patients being undertaken during the […]

1. • Obstructive sleep apnoea. • Myasthenia gravis. • Severe hepatic insufficiency. • Acute and/or severe respiratory depression. In the absence of data, zolpidem should not be prescribed for children or patients with psychotic illness.