Pronunciation:

zoe-PIK-lone

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Nonbarbiturate Hypnotic

Uses of This Medicine:

Zopiclonebelongs 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.

Before Using This Medicine:

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 this medicine, the following should be considered:

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.

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Sodium Oxybate

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Buprenorphine
• Carbinoxamine
• Fentanyl
• Fospropofol
• Hydrocodone
• Meclizine
• Morphine
• Morphine Sulfate Liposome
• Oxycodone
• Oxymorphone
• Suvorexant
• Tapentadol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Perampanel

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you 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)—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

Proper Use of This Medicine:

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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using 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—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

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.

Side Effects of This Medicine:

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

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice 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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.