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eszopiclone (Oral route)

es-zoe-PIK-lone

Commonly used brand name(s):

In the U.S.

Lunesta

Available Dosage Forms:

Tablet

Therapeutic Class: Nonbarbiturate Hypnotic

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Uses For eszopiclone

Eszopiclonebelongs to the group of medicines called central nervous system (CNS) depressants (medicines that make you drowsy or less alert). eszopiclone 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.

eszopiclone is available only with your doctor's prescription.

Before Using eszopiclone

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 eszopiclone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to eszopiclone 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 eszopiclone 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

eszopiclone 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

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Interactions with Medicines

Using eszopiclone 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.

Fospropofol
Tapentadol

Using eszopiclone 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.

Ketoconazole

Interactions with Food/Tobacco/Alcohol

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.

Using eszopiclone with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use eszopiclone, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use of eszopiclone

Take eszopiclone 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 eszopiclone 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 eszopiclone 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 eszopiclone. 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.

Precautions While Using eszopiclone

eszopiclone 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.

eszopiclone 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 eszopiclone.

eszopiclone 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 eszopiclone 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 eszopiclone 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.

eszopiclone 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:

Symptoms of Overdose

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:

More Common

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

Less common

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

Frequency not known

Loss of memory
problems with memory

After you stop using eszopiclone, 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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