Zopiclone 10mg (14 Tabs)

Treatment with zopiclone sleeping pills 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.

Dosage and administration:

• Imovane should only be taken when you are able to get a full night’s sleep (7 to 8 hours) before you need to be active again.
• The standard adult dose of zopiclone is one tablet just before you go to bed.
• This medication should be taken in a single intake and not readministered during the same night.
• If you are over 65 years of age the dose is half a tablet taken just before you go to bed.
• If you have a liver or kidney problem, the usual recommended dose is half a tablet taken just before you go to bed.

Dosage forms and strengths:

Imovane (Zopiclone) tablets 7.5 mg.
Zopisign (Zopiclone) tablets 10 mg.

Overdosage:

Signs and symptoms:

Overdose by zopiclone pills 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.

In voluntary or accidental cases of zopiclone overdosage involving doses up to 340 mg, the principal effects reported were prolonged sleep, drowsiness, lethargy and ataxia.

Recommended treatment:

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.

Hemodialysis is of no value due to the large volume of distribution of zopiclone. Flumazenil may be a useful antidote; however, flumazenil administration may contribute to the appearance of neurological symptoms (agitation, anxiety, convulsionsand emotional lability). Intravenous fluids should be administered as needed.

Contraindications:

Imovane (Zopiclone) is contraindicated in patients with:

known hypersensitivity to the drug or to any component inits formulation
myasthenia gravis
severe hepatic insufficiency
severe impairment of respiratory function (e.g., significant sleep apnea syndrome)

Warnings and precautions:

Avoid to take Zopiclone (Imovane) tablets if you have:

been drinking alcohol or you believe that you may have alcohol in your bloodstream
sleep apnoea (a condition where you temporarily stop breathing while you sleep)
myasthenia gravis (a condition in which the muscles become weak and tire easily)
severe liver problems
acute and/or severe lung problems
had a stroke
as a long term treatment
ever experienced sleep-walking or other unusual behaviour (suchas driving, eating, making a phone call or having sex etc.) while not being fully awake after taking zopiclone

Adverse reactions, side effects:

Most common zopiclone adverse reactions: headaches, dry mouth, bitter taste in your mouth, drowsiness.

Less common side effects include: heartburn, nausea, vomiting and/or diarrhoea, change in appetite, stomach pain, rash, agitation, depression, confusion, anxiety, dizziness, blurred vision, impotence, sleep walking or other unusual behaviours (such as driving, eating, making a phone call, or having sex etc.) while not being fully awake.

To report suspected adverse reactions of Imovane (Zopiclone) tablets, contact Sanofi pharmaceutical company or your local FDA.