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Duration of treatment Treatment should be as short as possible and should not exceed 4 weeks including the tapering off process. 4). Posology Adults 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 total dose of Zolpidem should not exceed 10 mg in any patient.

Elderly (over 65 years) or debilitated patients 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. 2); therefore 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). Renal impairment A dose adjustment is not necessary for patients with renal impairment. 4 under ‘Specific patient groups’) 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. Method of administration For sublingual use. Zolpidem acts rapidly and therefore should be taken just before going to bed, or in bed. The tablet should be put under the tongue and should be kept there until dissolved. 2).

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 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 frequently in elderly patients.

g. 4). The majority of the psychiatric side effects are related to paradoxical reactions. 4) Drug tolerance, Amnesia Anterograde amnesia may occur during therapeutic dosages, the risk increasing at higher dosages. In order to reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of 8 hours.

4). 4). Psychiatric and ‘paradoxical’ reactions Reactions like restlessness, agitation, irritability, aggressiveness, delusions, rage, nightmares, increased insomnia, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects may occur when using benzodiazepines and benzodiazepine-like agents.

4). 4). Psychic dependence may occur. Abuse has been reported in polydrug abusers. 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.

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General The cause of insomnia should be identified wherever possible. The underlying factors should be 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.

2), and should not exceed 4 weeks including the tapering off process. Extension beyond these periods should not take place without re-evaluation of the patient´s status. It may be useful to inform the patient when treatment is started that it will be of limited duration and explain exactly how the dose is gradually decreased when treatment is stopped.

8). 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 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). Precautions Psychosis Hypnotics such as zolpidem are not recommended for the primary treatment of psychoses. Amnesia Benzodiazepines or benzodiazepine-like agents may induce anterograde amnesia.

The condition usually occurs several hours after ingesting the product. 8). Depression Benzodiazepine and benzodiazepine-like agents such as zolpidem should not be used without appropriate treatment of the depression or anxiety associated with depression (suicide may be precipitated in such patients).

Zolpidem should be administered with caution in patients exhibiting symptoms of depression. Suicidal tendencies may be present. Due to the possibility of intentional overdose by the patient, the lowest amount of the drug that is feasible should be supplied to these patients.

1. Severe hepatic insufficiency. Obstructive sleep apnoea. Myasthenia gravis. Acute and/or severe respiratory insufficiency. 4).