LUNESTA- eszopiclone tablet, coated
PD-Rx Pharmaceuticals, Inc.
LUNESTA ® (lū'-nes''-tă) Tablets, Coated C-IV
Read the Medication Guide that comes with LUNESTA 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 LUNESTA?
LUNESTA may cause serious side effects, including:
Complex sleep behaviors that have caused serious injury and death. After taking LUNESTA, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing (complex sleep behaviors). The next morning, you may not remember that you did anything during the night. These activities may occur with LUNESTA whether or not you drink alcohol or take other medicines that make you sleepy.
Reported activities and behaviors include:
Stop taking LUNESTA and call your healthcare provider right away if you find out that you have done any of the above activities after taking LUNESTA.
The morning after you take LUNESTA your ability to drive safely and think clearly may be decreased. You also may experience sleepiness during the day.
Do not take LUNESTA if you:
WHAT IS LUNESTA?
LUNESTA is a sedative-hypnotic (sleep) medicine. LUNESTA is used in adults for the treatment of a sleep problem called insomnia. Symptoms of insomnia include:
LUNESTA is not for children.
|LUNESTA is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep LUNESTA in a safe place to prevent misuse and abuse. Selling or giving away LUNESTA 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 LUNESTA?
LUNESTA may not be right for you. Before starting LUNESTA, tell your doctor about all of your health conditions, including if you:
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 LUNESTA 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 LUNESTA?
What are the possible side effects of LUNESTA?
Possible serious side effects of LUNESTA include:
Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using LUNESTA.
The most common side effects of LUNESTA are:
These are not all the side effects of LUNESTA. 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 LUNESTA?
General Information about LUNESTA
This Medication Guide summarizes the most important information about LUNESTA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about LUNESTA that is written for healthcare professionals.
What are the ingredients in LUNESTA?
Active Ingredient: eszopiclone
Inactive Ingredients: calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Sunovion Pharmaceuticals Inc.
Marlborough, MA 01752 USA
© 2019 Sunovion Pharmaceuticals Inc. All rights reserved.
LUNESTA is a registered trademark of Sunovion Pharmaceuticals Inc.