Posology: The treatment should be taken in a single intake and not be re-administered during the same night.
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. 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 Precautions).
The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening.
If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness.
Use the lowest effective dose for the patient.
The total dose of zolpidem should not exceed 10 mg once daily immediately before bedtime.
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. The available evidence from placebo-controlled clinical trials is presented in Pharmacology: Pharmacodynamics under Actions.
Elderly: The recommended dose of zolpidem in elderly patients is 5 mg once daily immediately before bedtime. 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: The recommended dose of zolpidem in patients with hepatic insufficiency is 5 mg once daily immediately before bedtime. 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.
Zolpidem must not be used in patients with severe hepatic impairment as it may contribute to encephalopathy (see Contraindications).
Method of administration: Oral administration.