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LUNESTA (ESZOPICLONE): MEDICATION GUIDE
Lunesta coated tablets (Eszopiclone)
Read the Medication Guide that comes with Lunesta (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 (Lunesta)?
After taking Lunesta (Eszopiclone) tablets, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with Lunesta. Reported activities include:
making and eating food
driving a car ("sleep-driving")
talking on the phone
Call your doctor, pharmacist, or other healthcare professional right away if you find out that you have done any of the above activities after taking Eszopiclone (Lunesta).
1. Take Eszopiclone (Lunesta) tablets exactly as prescribed
Do not take more Lunesta than prescribed.
Take this medication right before you get in bed, not sooner.
2. Do not take Lunesta (Eszopiclone) if you:
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 (Lunesta) with your other medicines
cannot get a full night's sleep
What is Lunesta (Eszopiclone)?
Eszopiclone (Lunesta) is a sedative-hypnotic (sleep) medicine. This drug is used in adults for the treatment of a sleep problem called insomnia.
Symptoms of insomnia include:
trouble falling asleep
waking up often during the night
Lunesta (Eszopiclone) tablets are not for children.
Eszopiclone is a federally controlled substance (C-IV in The USA) because it can be abused or lead to dependence. Keep this medicine in a safe place to prevent misuse and abuse. Selling or giving away Lunesta (Eszopiclone) may harm others, and is against the law. Tell your physician if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
Who should not take Eszopiclone (Lunesta) tablets?
Do not take Lunesta (Eszopiclone) if you are allergic to anything in it.
See the end of this Medication Guide for a complete list of ingredients in Lunesta (Eszopiclone) tablets.
This medication may not be right for you. Before starting Eszopiclone (Lunesta), tell your healthcare provider about all of your health conditions, including if you:
have a history of drug or alcohol abuse or addiction
have a history of depression, mental illness, or suicidal thoughts
are pregnant, planning to become pregnant, or breastfeeding
have liver disease
Tell your doctor, pharmacist, or other healthcare professional 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 Lunesta (Eszopiclone) tablets 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 (Lunesta) tablets?
Take this medicine exactly as prescribed. Do not take more Lunesta (Eszopiclone) than prescribed for you.
Take Eszopiclone (Lunesta) right before you get into bed.
Do not take Lunesta with or right after a meal.
Do not take Eszopiclone unless you are able to get a full night's sleep before you must be active again.
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.
If you take too much Lunesta (Eszopiclone) tablets or overdose, call your doctor or poison control center right away, or get emergency treatment.
What are the possible side effects of Lunesta (Eszopiclone)?
Possible serious side effects of Eszopiclone (Lunesta) tablets include:
getting out of bed while not being fully awake and do an activity that you do not know you are doing.
abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, hallucinations, agitation, worsening of depression, and suicidal thoughts or actions.
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 Lunesta (Eszopiclone).
Call your doctor, pharmacist, or other healthcare professional right away if you have any of the above side effects or any other side effects that worry you while using Lunesta (Eszopiclone) tablets.
The most common side effects of Eszopiclone (Lunesta) are:
unpleasant taste in mouth, dry mouth
symptoms of the common cold
You may still feel drowsy the next day after taking Lunesta (Eszopiclone) tablets. Do not drive or do other dangerous activities after taking this medication until you feel fully awake.
These are not all the side effects of Lunesta (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.
How should I store Eszopiclone (Lunesta) tablets?
Store Lunesta at room temperature, between 59°F to 86°F (15°C to 30°C).
Do not use Eszopiclone after the expiration date.
Keep this drug and all medicines out of reach of children.
General Information about Lunesta (Eszopiclone)
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
Do not use Lunesta (Eszopiclone) tablets for a condition for which it was not prescribed.
Do not share Eszopiclone (Lunesta) tablets with other people, even if you think they have the same symptoms that you have.
This Medication Guide summarizes the most important information about Lunesta (Eszopiclone). If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Eszopiclone (Lunesta) that is written for healthcare professionals.
What are the ingredients in Lunesta (Eszopiclone) tablets?
Active Ingredient: eszopiclone.
Inactive Ingredients: colloidal silicon dioxide, calcium phosphate, croscarmellose sodium, lactose, hypromellose, magnesium stearate, polyethylene glycol, microcrystalline cellulose, titanium dioxide, and triacetin.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured and distributed by Sepracor pharmaceutical company and its divisions.
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