![]() ![]() Zolpidem must not be used in patients with severe hepatic impairment as it may contribute to encephalopathy (see section 4.3). ![]() 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. These recommended doses should not be exceeded.Īs 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. The available evidence from placebo-controlled clinical trials is presented in section 5.1.Įlderly or debilitated patients may be especially sensitive to the effects of zolpidem therefore a 5 mg dose is recommended. 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. Extension beyond the maximum treatment period should not take place without re-evaluation of the patient's status, since the risk of abuse and dependence increases with the duration of treatment (see section 4.4). Treatment should be as short as possible and should not exceed four weeks including the period of tapering off. The lowest effective daily dose of zolpidem should be used and must not exceed 10 mg.Īs with all hypnotics, long-term use is not recommended. The recommended daily dose for adults is 10 mg to be taken immediately at bedtime. The treatment should be taken in a single intake and not be re-administered during the same night. Date of first authorisation/renewal of the authorisation 6.6 Special precautions for disposal and other handling.4.7 Effects on ability to drive and use machines.4.5 Interaction with other medicinal products and other forms of interaction.4.4 Special warnings and precautions for use.4.2 Posology and method of administration.Show table of contents Hide table of contents
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