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Concise Prescribing Info
Short-term treatment of insomnia, including difficulties in falling asleep, nocturnal awakening & early awakening, transient, situational or chronic insomnia, & insomnia secondary to psychiatric disturbances, in conditions where the insomnia is debilitating or causing severe distress to the patient.
Dosage/Direction for Use
Adult Initially 3.75 mg (½ of 7.5-mg tablet). Max dose of 7.5 mg. Duration of treatment: Usually, should not exceed 7-10 consecutive days. Transient insomnia 2-5 days. Short-term insomnia 2-3 wk. Use for >2-3 consecutive wk requires complete re-evaluation of the patient.
May be taken with or without food: Take at bedtime.
Hypersensitivity. Myasthenia gravis, resp failure, severe sleep apnoea syndrome, severe hepatic insufficiency.
Special Precautions
history of alcohol and or drug abuse, or those patients who have marked personality disorders. Risk of withdrawal/rebound (insomnia) phenomena after prolonged treatment or abrupt discontinuation of therapy. Discontinue in case of somnambulism & associated behaviours eg, sleep walking & other associated behaviours eg, "sleep driving", preparing/eating food, or making phone calls w/ amnesia for the event. Avoid alcohol intake. May impair ability to drive or operate machinery. Pregnancy & lactation.
Adverse Reactions
Dysgeusia, somnolence (residual), drowsiness; dry mouth.
Drug Interactions
Enhance sedative effect w/ alcohol. Enhance the central depressive effect w/ antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, antiepileptic drugs, anaesth & sedative antihistamines. Enhance euphoria which may lead to increase in psychic dependence w/ narcotic analgesics. CYP450 may enhance the activity of benzodiazepines & benzodiazepine-like agents. Increase plasma levels w/ CYP3A4 inhibitors (erythromycin, clarithromycin, ketoconazole, itraconazole & ritonavir). Decrease plasma levels w/ CYP3A4 inducers (rifampicin, carbamazepine, phenobarb, phenytoin & St. John's wort).
ATC Classification
N05CF01 - zopiclone ; Belongs to the class of benzodiazepine related agents. Used as hypnotics and sedatives.
Zopistad FC tab 7.5 mg
1 × 10's
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