Regulatory Information
SANOFI-AVENTIS SINGAPORE PTE. LTD.
SANOFI-AVENTIS SINGAPORE PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
TABLET, MULTILAYER, EXTENDED RELEASE
**DOSAGE AND ADMINISTRATION** The treatment should always be implemented at the lowest effective dose, and the maximum dosage should never be exceeded. STILNOX CR acts rapidly and should therefore be taken immediately before retiring. As with all hypnotics, long-term use is not recommended and a course of treatment should not exceed four weeks. The effect of Stilnox CR may be slowed by ingestion with or immediately after a meal. The lowest effective daily dose of zolpidem should be used and must not exceed 12.5 mg. As with all hypnotics, long-term use of zolpidem is not recommended. Treatment should be as short as possible and should not exceed four weeks. 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. **Discontinuation of treatment:** see **ADVERSE REACTION** section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. **Withdrawal Effects:** see **PRECAUTIONS** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. **Recommended Dosage:** Tablets should not be divided, crushed or chewed. Adults The recommended daily dose is 12.5 mg. Elderly or Debilitated Patients The recommended daily dose is 6.25 mg. Hepatic Impairment The recommended daily dose is 6.25 mg and these patients should be closely monitored. STILNOX CR should not be used in patients with severe hepatic impairment (see **CONTRAINDICATIONS**). Renal impairment No dosage adjustment is necessary in these patients, although they should be closely monitored. Children As the safety and efficacy of STILNOX CR has not yet been established, the use of STILNOX CR in children under 18 years of age is contra-indicated.
ORAL
Medical Information
**INDICATIONS** STILNOX CR is indicated for the short-term treatment of insomnia in adults (see **DOSAGE AND ADMINISTRATION**).
**CONTRAINDICATIONS** Zolpidem is contraindicated in patients - With a hypersensitivity to zolpidem or any of the inactive ingredients, - With severe hepatic insufficiency, - With acute and/or severe respiratory insufficiency, - Who have previously experienced complex sleep behaviors after taking STILNOX CR, - Who have myasthenia, - Who have sleep apnea syndrome. Due to lactose content, this medicinal product is contraindicated in the event of congenital galactosaemia, glucose or galactose malabsorption syndrome or lactase deficiency. STILNOX CR should not be prescribed for children under 18 years of age.
N05CF02
zolpidem
Manufacturer Information
SANOFI-AVENTIS SINGAPORE PTE. LTD.
SANOFI WINTHROP INDUSTRIE
Active Ingredients
Documents
Package Inserts
Stilnox CR Modified Release Tablet PI.pdf
Approved: January 19, 2021