IMOVANE TABLET 7.5 mg

Therapeutic indications

IMOVANE is intended for treatment of short-term treatment of insomnia in adults (including difficulties with falling asleep, nocturnal awakening, and early wakening).

How should this medicinal product be used

Strictly follow the recommended dosage unless directed otherwise by the physician.

Contraindications

IMOVANE is contraindicated in patients:

• With myasthenia gravis
• With hypersensitivity to zopiclone or any of the excipients
• With respiratory failure
• With severe sleep apnea syndrome
• With severe hepatic insufficiency
• Who have previously experienced complex sleep behaviors after taking IMOVANE

Dosage and method of administration

Use the lowest effective dose. IMOVANE should be taken in a single intake and not be re-administered during the same night.

Adults: the recommended dose is one 7.5 mg IMOVANE tablet by oral route. This dose should not be exceeded.

As with all hypnotics, long-term use of zopiclone 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.

The product must be taken just before retiring for the night.

Treatment duration

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.

Special populations

In elderly and in patients with impaired liver function or chronic respiratory insufficiency: a starting dose of 3.75 mg zopiclone (half a tablet) is recommended initially. The dosage subsequently may be increased to 7.5 mg.

In patients with renal insufficiency: although no accumulation of zopiclone or of its metabolites has been detected in cases of renal insufficiency, it is recommended that patients with impaired renal function should start treatment with 3.75 mg.

The safe and effective dose of zopiclone has not been established in children and young adults less than 18 years.