Zopiclone is indicated for the short-term treatment and symptomatic relief of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings and/or early morning awakenings.
Miscellaneous sedatives & hypnotics
Zopiclone, a cyclopyrrolone derivative, is a short-acting hypnotic agent. This is structurally unrelated to existing hypnotics. However, the pharmacological profile of Zopiclone is similar to that of the benzodiazepines. Zopiclone pharmacological properties are: hypnotic, sedative, anxiolytic, anti-convulsant, muscle-relaxant. These effects are related to a specific agonist action at central receptors belonging to the GABAA macromolecular complex, modulating the opening of the chloride ion channel.
Zopiclone may produce more pronounced side effects when co- administered with:
Alcohol
Other tranquilizers or sleeping pills
Sedative antihistamines
Anticonvulsants (medicines used to control or prevent convulsions)
Narcotic analgesics (opioids)
Antipsychotics, antidepressants and other psychotropic medications (mood altering drugs) which themselves can make you sleepy.
Zopiclone is contraindicated in patients with severe hepatic insufficiency, contraindicated in patients with severe impairment of respiratory function.
Common side effects are somnolence, dizziness, confusion, anterograde amnesia or memory impairment, feeling of drunkenness, euphoria, nightmares, agitation, anxiety or nervousness, hostility, depression, decreased libido, libido disorder, coordination abnormality, headache, hypotonia, tremor, muscle spasms, paresthesia, and speech disorder, palpitations, dysgeusia (bitter taste), dry mouth, coated tongue, bad breath, nausea, vomiting, diarrhea, constipation, anorexia or increased appetite.
Do no take Zopiclone at anytime during pregnancy, it may affect the developing baby. Zopiclone passes into breast milk. Therefore, if you are breast feeding, this medicine should be avoided. Your doctor will discuss this with you
Do not take more Zopiclone than prescribed.
Do not use for longer than recommended by your physician. Treatment should be as short as possible, because the risk of dependence increases with the duration of treatment.
Do not take Zopiclone if you drink alcohol.
Talk to your doctor if you have had episodes of sleepwalking in the past, or if there is a history of sleepwalking in your family.
Talk to your doctor if you have a condition that affects your sleep, such as Periodic Limb Movement Disorder (involuntary movement of limbs during sleep) or Restless Legs Syndrome (urge to move legs, usually accompanied by uncomfortable and unpleasant sensations, that begins or worsens during periods of inactivity, typically in the evening and night).
Overdose is usually manifested by varying degrees of central nervous system depression ranging from drowsiness to coma according to the quantity ingested. In mild cases, symptoms include drowsiness, confusion, and lethargy; in more severe cases, symptoms may include ataxia, hypotonia, hypotension, methaemoglobinaemia, respiratory depression, and coma. Overdose should not be life threatening unless combined with other CNS depressants, including alcohol. Other risk factors, such as the presence of concomitant illness and the debilitated state of the patient, may contribute to the severity of symptoms and very rarely can result in fatal outcome. Symptomatic and supportive treatment in adequate clinical environment is recommended, attention should be paid to respiratory and cardiovascular functions. Gastric lavage or activated charcoal is only useful when performed soon after ingestion.
Store in a dry place, at room temperature (15°C to 30°C). Protect from light. Keep in a safe place out of reach of children.
