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US Brand Names

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Description

Eszopiclonebelongs 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). Eszopiclone 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 7 to 10 days, and generally for no longer than 2 weeks.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

• Tablet

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Before Using

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:

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.

Pediatric

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

Geriatric

This medicine has been tested and has not been shown to cause different side effects or problems in older adults than it does in younger adults.

Pregnancy

Breastfeeding

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.

Drug Interactions

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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) or
• Psychiatric disorders—Dependence on eszopiclone may develop.

• Liver disease (severe)—Higher blood levels of eszopiclone may result, increasing the chance of side effects.

• Mental depression—Eszopiclone may make these conditions worse.

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Proper Use

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 (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.

The importance of swallowing the tablet whole, do not chew, crush or break the tablet.

You should not take eszopiclone with or immediately after a high-fat meal or a heavy meal.

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—1 to 2 milligrams (mg) at bedtime.
    • Children—Use and dose must be determined by your doctor.

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Precautions

This medicine works very quickly. You should take eszopiclone immediately before going to bed.

If you think you need to take eszopiclone for more than 2 weeks, 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 eszopiclone 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 eszopiclone 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 eszopiclone, 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 eszopiclone 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 eszopiclone for insomnia, you may have difficulty sleeping (rebound insomnia) for the first few nights after you stop taking it.

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Side Effects

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 immediately if any of the following side effects occur:

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

• Change in consciousness
• Confusion
• Loss of consciousness
• Sleepiness or unusual drowsiness
• Very drowsy or sleepy

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:

• Acid or sour stomach
• Belching
• Cough or hoarseness
• Dizziness
• Dry mouth
• Fever or chills
• Headache
• Heartburn
• Indigestion
• Lower back or side pain
• Nausea
• Nervousness
• Pain
• Painful or difficult urination
• Sleepiness or unusual drowsiness
• Stomach discomfort upset or pain
• Unpleasant taste

• Abnormal dreams
• Accidental injury
• Bladder pain
• Bloody or cloudy urine
• Chills
• Cold flu-like symptoms
• Cough or hoarseness
• Decreased interest in sexual intercourse
• Diarrhea
• Difficult, burning, or painful urination
• Discouragement
• Fear
• Feeling sad or empty
• Frequent urge to urinate
• Inability to have or keep an erection
• Irritability
• Itching skin
• Lack of appetite
• Loss in sexual ability, desire, drive, or performance
• Loss of interest or pleasure
• Mood or mental changes
• Nerve pain
• Nervousness
• Pain, cramps, heavy bleeding (females)
• Rash
• Seeing, hearing, or feeling things that are not there
• Swelling of the breasts or breast soreness (males)
• Tiredness
• Trouble concentrating
• Trouble sleeping
• Vomiting

• Loss of memory
• Problems with memory

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:

• Abnormal dreams
• Fear
• Nervousness
• Nausea
• Upset stomach

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

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