Zopistad 7.5

Rx

Indications:

Short-term treatment of insomnia, including difficulties in falling asleep, nocturnal awakening and early awakening, transient, situational or chronic insomnia, and insomnia secondary to psychiatric disturbances, in situations where the insomnia is debilitating or is causing severe distress for the patient.

Dosage:

• Adults: The usual oral dose: 7.5 mg.
• In elderly patients: Treatment should start with a dose of 3.75 mg.
• Patients with mild to moderate hepatic impairment or renal impairment: Treatment with zopiclone should start with an oral dose of 3.75 mg.

Usage:

Zopistad 7.5 is orally administered, before bed and in the standing position. A course of treatment should employ the lowest effective dose.

Treatment duration: Transient insomnia 2 – 5 days. Short-term insomnia 2 – 3 weeks. A single course of treatment should not continue for longer than 4 weeks including any tapering off.

Hypersensitivity to zopiclone or to any of the excipients.

Children.

Myasthenia gravis, respiratory failure, severe sleep apnoea syndrome, severe hepatic insufficiency.

The most frequently: A mild bitter or metallic after-taste.

Less commonly: Mild gastrointestinal disturbances, including nausea and vomiting, dizziness, headache, drowsiness and dry mouth.

Discontinuation of zopiclone should be strongly considered for patients who report of somnambulism and associated behaviours.

Patients should ensure that they take the tablet when certain of retiring for the night and they are able to have a full night’s sleep.

Zopiclone does not constitute a treatment for depression.

Rebound insomnia: Since the risk of withdrawal/rebound phenomena may be increased after prolonged treatment, or abrupt discontinuation of therapy, decreasing the dosage in a stepwise fashion may be helpful.

The risk of dependence is minimal when the duration of treatment is limited to not more than 4 weeks. The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a history of alcohol and/ or drug abuse, or those who have marked personality disorders. The decision to use a hypnotic in such patients should be taken only with this clearly in mind. If physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose – galactose malabsorption should not take Zopistad 7.5.

Zopistad 7.5 is not recommended for pregnant and nursing women.

Patients should be advised not to drive or operate machinery the day after treatment with Zopistad 7.5