ZOLPIDEM

4). Treatment should be given for the shortest possible duration. Posology The treatment should be as short as possible and should not last more than 4 weeks, including the tapering period. 4). Zolpidem effect sets in rapidly and must therefore be taken immediately before bedtime.

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.

Special populations Paediatric population Safety and efficacy in children and adolescents under 18 years of age have not been established. 1. Elderly and debilitated patients Elderly or debilitated patients may be especially sensitive to the effects of zolpidem therefore a 5 mg dose is recommended.

2), 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 For oral administration only.

The adverse drug reactions are stated in the table below using the following convention: 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 from the available data).

There is evidence for a dose connection for reactions associated with use of zolpidem, especially certain CNS-reactions. Theoretically they should be less if zolpidem is taken immediately before bedtime. They occur most frequently in elderly patients.

4). 4) The majority of the psychiatric side effects are related to paradoxica l reactions. 4). 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 authorization 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.

8). ” 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.

General about hypnotics General information relating to effects seen following administration of hypnotic agents which should be taken into account by the prescribing physician are described below. 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.

Zolpidem is contraindicated in patients with: • Myasthenia gravis. • Obstructive sleep apnea. • Severe hepatic insufficiency • Acute and / or severe respiratory insufficiency. 1. 1).