Sandoz Zopiclone 7,5 mg FC tablets

Indication

Short-term treatment of insomnia.

Dosage (summary)

The usual dose is 7.5 mg taken orally just before bedtime. The maximum recommended dose is 7.5 mg.

Onset of Action / Duration

Effects typically begin within 30 minutes and last for approximately 6 to 8 hours.

Special Populations

• Elderly patients may require a lower dose due to increased sensitivity.
• Patients with hepatic impairment should use with caution and may require dose adjustment.
• Patients with renal impairment should use with caution.

Pregnancy & Breastfeeding

Zopiclone should be avoided during pregnancy and lactation unless the benefits outweigh the risks, as it may cause harm to the fetus or infant.

Key Drug Interactions

• CNS depressants (e.g., alcohol, benzodiazepines) may enhance sedative effects.
• Certain antidepressants and antipsychotics may increase the risk of sedation.
• CYP3A4 inhibitors may increase plasma levels of Zopiclone.

Contraindications

• Hypersensitivity to Zopiclone or any of its excipients.
• Severe respiratory insufficiency.
• Sleep apnea syndrome.
• Myasthenia gravis.

Common side effects

• Drowsiness.
• Dizziness.
• Dry mouth.
• Headache.
• Nausea.
• Confusion.

Counselling Points

• Advise patients to take Zopiclone just before bedtime.
• Instruct patients to avoid alcohol and other CNS depressants while taking this medication.
• Warn patients about the potential for next-day drowsiness and to avoid driving or operating heavy machinery until they know how Zopiclone affects them.
• Inform patients to not exceed the recommended dose or duration of treatment.