ZOPICLONE (Systemic)*
Some commonly used brand names are:
In Canada?
* Not commercially available in the U.S.
Category
Description
Zopiclone(ZOP-i-klone)belongs to the group of medicines called centralnervous system (CNS) depressants (medicines that make you drowsy or lessalert). This medicine is used to treat insomnia (trouble in sleeping). Zopiclonehelps you get to sleep faster and sleep through the night. In general, whensleep medicines are used every night for a long time, they may lose theireffectiveness. In most cases, sleep medicines should be used only for shortperiods of time, such as 1 or 2 days, and generally for no longer than 1 or2 weeks.
This medicine is available only with your doctor's prescription, in thefollowing dosage forms:
Before Using This Medicine
Sleep medicinesmay cause a special type of memory loss or ``amnesia''. When this occurs,a person does not remember what has happened during the several hours betweenuse of the medicine and the time when its effects wear off. This is usuallynot a problem since most people fall asleep after taking the medicine. Inmost instances, memory problems can be avoided by taking zopiclone only whenyou are able to get a full night's sleep (7 to 8 hours) before you need tobe active again. Be sure to talk to your doctor if you think you are havingmemory problems.
In deciding to use a medicine, the risks of taking the medicine must beweighed against the good it will do. This is a decision you and your doctorwill make. For zopiclone, the following should be considered:
Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to zopiclone. Also tell your doctor and pharmacist ifyou are allergic to any other substances, such as foods, preservatives, ordyes.
Pregnancy?Zopiclone has not been studied in pregnant women.In studies of pregnant animals that received doses of zopiclone many timesthe human dose , fewer offspring survived. Before taking this medicine, makesure your doctor knows if you are pregnant or if you may become pregnant.
Breast-feeding?Zopiclone passes into breast milk and may causeunwanted effects in nursing babies. It may be necessary for you to take anothermedicine or to stop breast-feeding during treatment. Be sure you have discussedthe risks and benefits of the medicine with your doctor.
Children?Studies on this medicine have been done only inadult patients, and there is no specific information comparing use of zopiclonein children with use in other age groups.
Older adults?Confusion, lack of coordination, and falling aremore likely to occur in the elderly, who are usually more sensitive than youngeradults to the effects of zopiclone.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingzopiclone, it is especially important that your doctor and pharmacist knowif you are taking any of the following:
- Other central nervous system (CNS) depressants (medicines that causedrowsiness) or
- Tricyclic antidepressants (medicines for depression)?The CNSdepressant effects of either these medicines or zopiclone may be increased,possibly leading to unwanted effects
Other medical problems?The presence of other medicalproblems may affect the use of zopiclone. Make sure you tell your doctor ifyou have any other medical problems, especially:
- 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)?Zopiclonemay make these conditions worse
- Kidney disease or
- Liver disease (severe)?Higher blood levels of zopiclone mayresult, increasing the chance of side effects
Proper Use of This Medicine
Take this medicine only as directed by your doctor. Do not take moreof it, do not take it more often, and do not take it for a longer time thanyour doctor ordered. If too much is taken, it may become habit-forming (causingmental or physical dependence).
Do not take this medicine when your schedule does notpermit you to get a full night's sleep (7 to 8 hours). If you mustwake up before this, you may continue to feel drowsy and may experience memoryproblems, because the effects of the medicine have not had time to wear off.
Dosing?The dose of zopiclone will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage 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 5to 7.5 mg as determined by your doctor.
- Children up to 18 years of age?Use and dose must be determinedby your doctor.
Missed dose?If you miss a dose of this medicine, skip themissed 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 otherdamp places. Heat or moisture may cause the medicine to break down.
- Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
Ifyou think you need to take zopiclone for more than 7 to 10 days, be sure todiscuss it with your doctor. Insomnia that lasts longer than this may be asign 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 antihistaminesor 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 dentalanesthetics. Check with your doctor before taking anyof the above while you are using this medicine.
This medicine may cause some people, especially older persons, to becomedrowsy, dizzy, lightheaded, clumsy or unsteady, or less alert than they arenormally. Even though zopiclone is taken at bedtime, it may cause some peopleto feel drowsy or less alert on arising. Make sure youknow how you react to zopiclone before you drive, use machines, or do anythingelse that could be dangerous if you are dizzy, or are not alert or able tosee well.
If you develop any unusual and strange thoughts or behavior while you aretaking zopiclone, be sure to discuss it with your doctor. Some changes thathave occurred in people taking this medicine are like those seen in peoplewho drink alcohol and then act in a manner that is not normal. Other changesmay be more unusual and extreme, such as confusion, worsening of depression,hallucinations (seeing, hearing, or feeling things that are not there), suicidalthoughts, and unusual excitement, nervousness, or irritability.
If you will be taking zopiclone for a long time, do not stop taking itwithout first checking with your doctor. Your doctor may want you to graduallyreduce the amount you are taking before stopping completely. Stopping thismedicine suddenly may cause withdrawal side effects.
After taking zopiclone for insomnia, you may have difficulty sleeping (reboundinsomnia) for the first few nights after you stop taking it.
If you think you or someone else may have taken anoverdose of this medicine, get emergency help at once. Taking an overdoseof zopiclone or taking alcohol or other CNS depressants with zopiclone maylead to breathing problems and unconsciousness. Some signs of an overdoseare clumsiness or unsteadiness, mental or mood changes, severe drowsiness,or unusual tiredness or weakness.
Side Effects of This Medicine
Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.
Check with your doctoras soon as possible if any of the following side effects occur:
Symptoms of overdose
Get emergency help immediately if any of the followingsymptoms 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 themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome.
Less common
Agitation?more common in older adults; chills; fast, irregular, or pounding heartbeat?morecommon in older adults; feeling of heaviness of armsand legs; increase in the amount of saliva?morecommon in older adults; increased sweating?morecommon in older adults; tingling, burning or pricklysensation; trembling and shaking of fingers, hands,arms, feet, or legs?more common in older adults; vomiting?more common in older adults
After you stop usingthis medicine, your body may need time to adjust. The length of time thistakes depends on the amount of medicine you were using and how long you usedit. During this time check with your doctor if you notice any of the followingside effects:
Abdominal or stomach cramps or pain; nausea; vomiting; more difficultyin sleeping than before treatment; muscle crampsor discomfort; anxiety; nervousness; irritability; restlessness; increased sweating; tremors; seizures
Zopiclone may cause you to have a coated tongue, badbreath, or a bitter taste. These effects are to be expected when you are takingthis medicine.
Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.
Developed: 05/30/2000
