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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.

Therapeutic Class:

Miscellaneous sedatives & hypnotics

Pharmacology:

Zopiclone, a cyclopyrrolone derivative, is a short-acting hypnotic agent. This is structurally unrelated to existing hypnotics. However, the pharmacological profile of Zopiclone is like 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 GABA_A macromolecular complex, modulating the opening of the chloride ion channel.

Dosage:

The recommended initial dose is 3.75 mg (one-half of a 7.5 mg tablet). The dose can be increased to 5 mg and further to 7.5 mg if clinically indicated.

In some patients, the higher doses result in zopiclone blood levels in the morning high enough to produce impairment of driving and other activities that require full alertness. The 7.5 mg dose should not be exceeded.

Administration:

Treatment with Zopiclone should usually not exceed 7-10 consecutive days. Use for more than 2-3 consecutive weeks requires complete re-evaluation of the patient. Prescriptions for Zopiclone should be written for short-term use (7-10 days) and it should not be prescribed in quantities exceeding a 1-month supply.

The use of hypnotics should be restricted for insomnia where disturbed sleep results in impaired daytime functioning.

Interaction:

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.

Contraindications:

Zopiclone is contraindicated in patients with severe hepatic insufficiency, contraindicated in patients with severe impairment of respiratory function.

Side Effects:

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.

Pregnancy & Lactation:

Do not take Zopiclone at any time 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

Precautions & Warnings:

• 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).

Use in Special Populations:

Zopiclone is not indicated for patients under 18 years of age.

Overdose Effects:

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.

Storage Conditions:

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.