STILNOCT Coated tablet Ref.[7405] Active ingredients: Zolpidem

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 tartrate should be used and must not exceed 10 mg.

The duration of treatment should usually vary from a few days to two weeks with a maximum of four weeks including tapering off where clinically appropriate.

Treatment should be as short as possible. It should not exceed four weeks including the period of tapering off. In certain cases extension beyond the maximum treatment period may be necessary; if so, 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).

Special populations

Paediatric population

Stilnoct 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 section 5.1.

Elderly

Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate therefore a 5 mg dose is recommended. These recommended doses should not be exceeded.

Hepatic impairment

As clearance and metabolism of zolpidem tartrate 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 section 4.3).

Method of administration

Oral administration.

Signs and symptoms

In cases of overdose involving zolpidem tartrate alone or with other CNS-depressant agents (including alcohol), impairment of consciousness ranging from somnolence to coma, and more severe symptomatology, including fatal outcomes have been reported.

Management

General symptomatic and supportive measures should be used. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. Sedating drugs should be withheld even if excitation occurs.

Use of flumazenil may be considered where serious symptoms are observed. Flumazenil is reported to have an elimination half-life of about 40–80 minutes. Patients should be kept under close observation because of this short duration of action; further doses of flumazenil may be necessary. However, flumazenil administration may contribute to the appearance of neurological symptoms (convulsions).

Zolpidem is not dialyzable. The value of dialysis in the treatment of an overdose has not been determined. Dialysis in patients with renal failure receiving therapeutic doses of zolpidem have demonstrated no reduction in levels of zolpidem.

In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken.

3 years.

Store in a dry place below 30°C.

Cartons of 4, 14, 28 or 56 tablets in PVC/foil blister strips of 7 or 14 tablets.

Please consult the package insert before use. Do not use after the stated expiry date on the carton and blister.

KEEP OUT OF THE REACH OF CHILDREN.