Concise Prescribing Info
Short-term treatment & symptomatic relief of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings &/or early morning awakenings.
Dosage/Direction for Use
Adult Initially 3.75 mg, can be increased to 5 mg then 7.5 mg if clinically indicated. Max: 7.5 mg. Elderly ≥65 yr &/or debilitated patient Initially 3.75 mg, may be increased to max 5 mg. Patient w/ impaired liver function or renal insufficiency 3.75 mg, may be increased to 5 mg if clinically indicated. Patient w/ chronic resp insufficiency 3.75-7.5 mg.
Hypersensitivity. Myasthenia gravis, severe hepatic insufficiency, severe impairment of resp function (eg, significant sleep apnea syndrome).
Special Precautions
Extreme caution in patients w/ history of substance or alcohol abuse. Caution in patients who in the past manifested paradoxical reactions to alcohol &/or sedative medication; patients w/ signs & symptoms of depression; patients w/ personal or family history of sleepwalking. Risk of anterograde amnesia; abnormal thinking & other behavioural changes; daytime anxiety &/or restlessness; complex sleep-related behaviours eg, 'sleep-driving'. Affects mental efficiency eg, concentration, attention, vigilance. Greater risk of confusion in the elderly & in patients w/ cerebral impairment. May mask symptoms of depression. Use in patients w/ other disorders known to affect sleep & induce frequent awakenings (eg, sleep apnea, Periodic Limb Movement Disorder, Restless Legs Syndrome) is discouraged. May lead to development of abuse &/or physical & psychological dependence. Risk of rebound insomnia upon treatment w/drawal. Avoid abrupt discontinuation & gradually taper dose in any patient taking the drug for more than a few wk, especially in patients w/ history of seizures. Tolerance may develop after repeated use. Rare hereditary diseases of galactose intolerance. Do not take w/ alcohol. Caution when co-administered w/ opioids, benzodiazepines or other CNS depressant drugs; potent CYP3A4 inhibitors. Caution against engaging in hazardous occupations requiring complete mental alertness or motor coordination. Risk of next day psychomotor impairment. Rare cases of angioedema. Patients w/ impaired hepatic or renal function, chronic pulmonary insufficiency, compromised resp function. May cause fetal damage when administered during pregnancy. Not recommended during pregnancy & lactation. Should not be prescribed in ped patients. Elderly ≥65 yr.
Adverse Reactions
Taste alteration (bitter taste). Somnolence, dizziness, confusion, anterograde amnesia or memory impairment, feeling of drunkenness, euphoria, anxiety or nervousness, depression, coordination abnormality, hypotonia, speech disorder; dry mouth, coated tongue, bad breath; constipation, anorexia or increased appetite; asthenia.
Drug Interactions
Additive CNS depressant effects w/ alcohol, sedative antihistamines, anticonvulsants, narcotic analgesics, anesthetics, or psychotropic medications eg, antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, & antidepressant agents. Enhancement of euphoria w/ narcotic analgesics. Increased plasma levels w/ CYP3A4 inhibitors eg, erythromycin, clarithromycin, ketoconazole, itraconazole, & ritonavir. Decreased plasma levels w/ CYP3A4 inducers eg, rifampicin or rifampin, carbamazepine, phenobarb, phenytoin, & St. John's Wort. Increased risk of profound sedation, resp depression, coma & death w/ opioids.
MIMS Class
Hypnotics & Sedatives
ATC Classification
N05CF01 - zopiclone ; Belongs to the class of benzodiazepine related agents. Used as hypnotics and sedatives.
pms-Zopiclone tab 7.5 mg
100 × 10's;100's;3 × 10's;500's
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