MEDICATION GUIDE

Eszopiclone Tablets (ES-zoe-PIK-lone), coated CIV

Read the Medication Guide that comes with eszopiclone before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.

What is the most important information I should know about eszopiclone?

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Do not take more eszopiclone than prescribed

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Do not take eszopiclone unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again

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Take eszopiclone right before you get in bed, not sooner

Eszopiclone may cause serious side effects that you may not know are happening to you. These side effects include:

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sleepiness during the day

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not thinking clearly

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act strangely, confused, or upset

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"sleep-walking" or doing other activities when you are asleep like:

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eating

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talking

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having sex

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driving a car

Call your healthcare provider right away if you find out that you have done any of the above activities after taking eszopiclone.

The morning after you take eszopiclone your ability to drive safely and think clearly may be decreased.

Do not take eszopiclone if you:

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drank alcohol that evening or before bed

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take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take eszopiclone with your other medicines

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cannot get a full night’s sleep

What is eszopiclone?

Eszopiclone is a sedative-hypnotic (sleep) medicine. Eszopiclone is used in adults for the treatment of a sleep problem called insomnia. Symptoms of insomnia include:

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trouble falling asleep

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waking up often during the night

Eszopiclone is not for children.

Eszopiclone is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep eszopiclone in a safe place to prevent misuse and abuse. Selling or giving away eszopiclone may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take eszopiclone?

Do not take eszopiclone if you are allergic to anything in it.

See the end of this Medication Guide for a complete list of ingredients in eszopiclone.

Eszopiclone may not be right for you. Before starting eszopiclone, tell your doctor about all of your health conditions, including if you:

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have a history of depression, mental illness, or suicidal thoughts

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have a history of drug or alcohol abuse or addiction

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have liver disease

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are pregnant, planning to become pregnant, or breastfeeding

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects. Do not take eszopiclone with other medicines that can make you sleepy.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

How should I take eszopiclone?

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Take eszopiclone exactly as prescribed. Do not take more eszopiclone than prescribed for you

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Take eszopiclone right before you get into bed

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Do not take eszopiclone with or right after a meal

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Do not take eszopiclone unless you are able to get a full night’s sleep before you must be active again

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Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problems

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If you take too much eszopiclone or overdose, call your doctor or poison control center right away, or get emergency treatment

What are the possible side effects of eszopiclone?

Possible serious side effects of eszopiclone include:

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getting out of bed while not being fully awake and do an activity that you do not know you are doing. (See “What is the most important information I should know about eszopiclone?)

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abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions

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memory loss

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anxiety

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severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking eszopiclone

Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using eszopiclone.

The most common side effects of eszopiclone are:

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unpleasant taste in mouth, dry mouth

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drowsiness

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dizziness

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headache

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symptoms of the common cold

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You may still feel drowsy the next day after taking eszopiclone. Do not drive or do other dangerous activities after taking eszopiclone until you feel fully awake.

These are not all the side effects of eszopiclone. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store eszopiclone?

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Store eszopiclone at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

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Do not use eszopiclone after the expiration date.

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Keep eszopiclone and all medicines out of reach of children.

General Information about eszopiclone

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Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

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Do not use eszopiclone for a condition for which it was not prescribed.

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Do not share eszopiclone with other people, even if you think they have the same symptoms that you have. It may harm them and is against the law.

This Medication Guide summarizes the most important information about eszopiclone. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about eszopiclone that is written for healthcare professionals.

For product information call 1-800-962-8364.

What are the ingredients in eszopiclone?

Active Ingredient: eszopiclone

Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose (anhydrous), magnesium stearate, microcrystalline cellulose and Opadry II (White). Opadry II (White) contains hypromellose, polydextrose, polyethylene glycol, titanium dioxide and triacetin.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distr. by: West-Ward

Pharmaceuticals Corp.

Eatontown, NJ 07724

10005923/03

Revised January 2016