In Canada—

• Sedative-hypnotic

Zopiclone ( ZOP-i-klone) belongs to the group of medicines called central nervous system (CNS) depressants (medicines that make you drowsy or less alert). This medicine is used to treat insomnia (trouble in sleeping). Zopiclone helps you get to sleep faster and sleep through the night. In general, when sleep medicines are used every night for a long time, they may lose their effectiveness. In most cases, sleep medicines should be used only for short periods of time, such as 1 or 2 days, and generally for no longer than 1 or 2 weeks.

This medicine is available only with your doctor's prescription, in the following dosage forms:

Oral
• Tablets (Canada)

Sleep medicines may cause a special type of memory loss or ``amnesia''. When this occurs, a person does not remember what has happened during the several hours between use of the medicine and the time when its effects wear off. This is usually not a problem since most people fall asleep after taking the medicine. In most instances, memory problems can be avoided by taking zopiclone only when you are able to get a full night's sleep (7 to 8 hours) before you need to be active again. Be sure to talk to your doctor if you think you are having memory problems.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For zopiclone, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to zopiclone. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Zopiclone has not been studied in pregnant women. In studies of pregnant animals that received doses of zopiclone many times the human dose , fewer offspring survived. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Zopiclone passes into breast milk and may cause unwanted effects in nursing babies. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of zopiclone in children with use in other age groups.

Older adults—Confusion, lack of coordination, and falling are more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of zopiclone.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking zopiclone, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Other central nervous system (CNS) depressants (medicines that cause drowsiness) or
• Tricyclic antidepressants (medicines for depression)—The CNS depressant effects of either these medicines or zopiclone may be increased, possibly leading to unwanted effects

• Alcohol abuse (or history of) or
• Drug abuse (or history of)—Dependence on zopiclone may develop

• Emphysema, asthma, bronchitis, or other chronic lung disease or
• Mental depression or
• Myasthenia gravis or
• Sleep apnea (temporary stopping of breathing during sleep)—Zopiclone may make these conditions worse

• Kidney disease or
• Liver disease (severe)—Higher blood levels of zopiclone may result, increasing the chance of side effects

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming (causing mental or physical dependence).

Do not take this medicine when your schedule does not permit you to get a full night's sleep (7 to 8 hours). If you must wake up before this, you may continue to feel drowsy and may experience memory problems, because the effects of the medicine have not had time to wear off.

Dosing—

The dose of zopiclone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of zopiclone. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine.

• For oral dosage form (tablets):
  • For the treatment of insomnia (trouble in sleeping)
    • Adults—5 to 7.5 milligrams (mg) at bedtime.
    • Older adults—3.75 mg at bedtime; dose may be increased to 5 to 7.5 mg as determined by your doctor.
    • Children up to 18 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

If you think you need to take zopiclone for more than 7 to 10 days, be sure to discuss it with your doctor. Insomnia that lasts longer than this may be a sign of another medical problem.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people, especially older persons, to become drowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they are normally. Even though zopiclone is taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to zopiclone before you drive, use machines, or do anything else that could be dangerous if you are dizzy, or are not alert or able to see well.

If you develop any unusual and strange thoughts or behavior while you are taking zopiclone, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

If you will be taking zopiclone for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. Stopping this medicine suddenly may cause withdrawal side effects.

After taking zopiclone for insomnia, you may have difficulty sleeping (rebound insomnia) for the first few nights after you stop taking it.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of zopiclone or taking alcohol or other CNS depressants with zopiclone may lead to breathing problems and unconsciousness. Some signs of an overdose are clumsiness or unsteadiness, mental or mood changes, severe drowsiness, or unusual tiredness or weakness.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • confusion—more common in older adults;  clumsiness or unsteadiness—more common in older adults;  daytime anxiety and/or restlessness;  difficulty with coordination—more common in older adults;  mood or mental changes 
  
  

• Less common
  • Drowsiness (severe);  shortness of breath ;  difficult or labored breathing;  tightness in chest;  wheezing;  skin rash;  aggressiveness;  behavior changes 
  
  

• Rare
  • Memory problems—more common in older patients;  behavior or mental changes 
  
  

• Symptoms of overdose

  Get emergency help immediately if any of the following symptoms of overdose occur

  • Clumsiness;  unsteadiness;  mental or mood changes;  drowsiness (severe) ;  unusual tiredness or weakness;  sluggishness;  reduced physical activity;  unusual sleepiness;  loss of consciousness  
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More common
  • Dizziness;  Dryness of mouth;  heartburn;  impaired vision;  increased appetite;  indigestion;  loss of appetite—more common in older adults;  stomach upset;  difficulty speaking;  constipation;  decreased muscle tone ;  weight loss 
  
  

• Less common
  • Agitation—more common in older adults;  chills;  fast, irregular, or pounding heartbeat—more common in older adults;  feeling of heaviness of arms and legs;  increase in the amount of saliva—more common in older adults;  increased sweating—more common in older adults;  tingling, burning or prickly sensation;  trembling and shaking of fingers, hands, arms, feet, or legs—more common in older adults;  vomiting—more common in older adults 
  
  

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this time check with your doctor if you notice any of the following side effects:

• Abdominal or stomach cramps or pain;  nausea;  vomiting;  more difficulty in sleeping than before treatment;  muscle cramps or discomfort;  anxiety;  nervousness;  irritability;  restlessness;  increased sweating;  tremors;  seizures 

Zopiclone may cause you to have a coated tongue, bad breath, or a bitter taste. These effects are to be expected when you are taking this medicine.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.