LUNESTA- eszopiclone tablet, coated

Lunesta by

Drug Labeling and Warnings

Lunesta by is a Prescription medication manufactured, distributed, or labeled by H.J. Harkins Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LUNESTA 2 mg tablets are round, white, film-coated, and identified with debossed markings of S191 on one side, and are supplied as:

  •   NDC: 63402-191-10            bottle of 100 tablets
  • LUNESTA 1 mg tablets are round, light blue, film-coated, and identified with debossed markings of S190 on one side, and are supplied as:

  •   NDC: 63402-190-30            bottle of 30 tablets
  • Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

    SUNOVION

    Manufactured for:
    Sunovion Pharmaceuticals Inc.
    Marlborough, MA 01752 USA

    For customer service, call 1-888-394-7377.
    To report adverse events, call 1-877-737-7226.
    For medical information, call 1-800-739-0565.

    © 2009, 2010 Sunovion Pharmaceuticals Inc. All rights reserved.
    Lunesta is a registered trademark of Sunovion Pharmaceuticals Inc.

  • MEDICATION GUIDE

    LUNESTA® (lū'-nes''-tă) Tablets, Coated C-IV
    (eszopiclone)

    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?

    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. 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:

    • driving a car ("sleep-driving")
    • making and eating food
    • talking on the phone
    • having sex
    • sleep-walking

    Call your doctor right away if you find out that you have done any of the above activities after taking LUNESTA.

    Important:

    1. Take LUNESTA exactly as prescribed

    • Do not take more LUNESTA than prescribed.
    • Take LUNESTA right before you get in bed, not sooner.

    2. Do not take LUNESTA if you:

    • drink alcohol
    • 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 LUNESTA with your other medicines
    • cannot get a full night's sleep

    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:

    • trouble falling asleep
    • waking up often during the night

    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?

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

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

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

    • have a history of depression, mental illness, or suicidal thoughts
    • have a history of drug or alcohol abuse or addiction
    • have liver disease
    • 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 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?

    • Take LUNESTA exactly as prescribed. Do not take more LUNESTA than prescribed for you.
    • Take LUNESTA right before you get into bed.
    • Do not take LUNESTA with or right after a meal.
    • Do not take LUNESTA 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 or overdose, call your doctor or poison control center right away, or get emergency treatment.

    What are the possible side effects of LUNESTA?

    Possible serious side effects of LUNESTA include:

    • 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 LUNESTA?)
    • abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions.
    • memory loss
    • anxiety
    • 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.

    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:

    • unpleasant taste in mouth, dry mouth
    • drowsiness
    • dizziness
    • headache
    • symptoms of the common cold
    • You may still feel drowsy the next day after taking LUNESTA. Do not drive or do other dangerous activities after taking LUNESTA until you feel fully awake.

    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?

    • Store LUNESTA at room temperature, between 59°F to 86°F (15°C to 30°C).
    • Do not use LUNESTA after the expiration date.
    • Keep LUNESTA and all medicines out of reach of children.

    General Information about LUNESTA

    • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
    • Do not use LUNESTA for a condition for which it was not prescribed.
    • Do not share LUNESTA 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 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.

    • For customer service, call 1-888-394-7377.
    • To report side effects, call 1-877-737-7226.
    • For medical information, call 1-800-739-0565.

    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.

    Rx Only

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

    SUNOVION

    Manufactured for:
    Sunovion Pharmaceuticals Inc.
    Marlborough, MA 01752 USA

    Repacked by:
    H.J. Harkins Company, Inc.
    Nipomo, CA 93444 USA

    © 2009, 2010, 2011 Sunovion Pharmaceuticals Inc. All rights reserved.
    Lunesta is a registered trademark of Sunovion Pharmaceuticals Inc.

    November 2010

    901031R06

  • 2 MG BOTTLE LABEL – PRINCIPAL DISPLAY PANEL – 2mg

    NDC: 63402-191-10

    100 Tablets

    Lunesta®

    (eszopiclone) Tablets

    2 mg C-IV

    DISPENSER: Each time Lunesta is

    dispensed give the patient a medication

    guide, also provided at www.Lunesta.com

    or 1-888-394-7377.

    SUNOVION

    Rx Only

    2 MG BOTTLE LABEL – PRINCIPAL DISPLAY PANEL – 2mg
  • 3 MG BOTTLE LABEL – PRINCIPAL DISPLAY PANEL – 3mg

    NDC: 63402-193-10

    100 Tablets

    Lunesta®

    (eszopiclone) Tablets

    3 mg C-IV

    DISPENSER: Each time Lunesta is

    dispensed give the patient a medication

    guide, also provided at www.Lunesta.com

    or 1-888-394-7377.

    SUNOVION

    Rx Only

    3 MG BOTTLE LABEL – PRINCIPAL DISPLAY PANEL – 3mg
  • INGREDIENTS AND APPEARANCE
    LUNESTA 
    eszopiclone tablet, coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 52959-919(NDC:63402-191)
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESZOPICLONE (UNII: UZX80K71OE) (ESZOPICLONE - UNII:UZX80K71OE) ESZOPICLONE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code S191
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 52959-919-3030 in 1 BOTTLE
    2NDC: 52959-919-6060 in 1 BOTTLE
    3NDC: 52959-919-00100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02147604/04/2005
    LUNESTA 
    eszopiclone tablet, coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 52959-852(NDC:63402-193)
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESZOPICLONE (UNII: UZX80K71OE) (ESZOPICLONE - UNII:UZX80K71OE) ESZOPICLONE3 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Product Characteristics
    Colorblue (dark blue) Scoreno score
    ShapeROUND (ROUND) Size6mm
    FlavorImprint Code S193
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 52959-852-1010 in 1 BOTTLE
    2NDC: 52959-852-1212 in 1 BOTTLE
    3NDC: 52959-852-3030 in 1 BOTTLE
    4NDC: 52959-852-6060 in 1 BOTTLE
    5NDC: 52959-852-00100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02147604/04/2005
    Labeler - H.J. Harkins Company, Inc. (147681894)
    Registrant - H.J. Harkins Company, Inc. (147681894)
    Establishment
    NameAddressID/FEIBusiness Operations
    H.J. Harkins Company, Inc.147681894repack, relabel

  • Trademark Results [Lunesta]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LUNESTA
    LUNESTA
    87485715 5350718 Live/Registered
    Sunovion Pharmaceuticals Inc.
    2017-06-12
    LUNESTA
    LUNESTA
    87485707 5350716 Live/Registered
    Sunovion Pharmaceuticals Inc.
    2017-06-12
    LUNESTA
    LUNESTA
    86008303 not registered Dead/Abandoned
    Sunovion Pharmaceuticals Inc.
    2013-07-11
    LUNESTA
    LUNESTA
    86008301 not registered Dead/Abandoned
    Sunovion Pharmaceuticals Inc.
    2013-07-11
    LUNESTA
    LUNESTA
    86008297 not registered Dead/Abandoned
    Sunovion Pharmaceuticals Inc.
    2013-07-11
    LUNESTA
    LUNESTA
    86008294 not registered Dead/Abandoned
    Sunovion Pharmaceuticals Inc.
    2013-07-11
    LUNESTA
    LUNESTA
    86008291 not registered Dead/Abandoned
    Sunovion Pharmaceuticals Inc.
    2013-07-11
    LUNESTA
    LUNESTA
    78867687 3839400 Dead/Cancelled
    SUNOVION PHARMACEUTICALS INC.
    2006-04-24
    LUNESTA
    LUNESTA
    78867683 3745483 Dead/Cancelled
    SUNOVION PHARMACEUTICALS INC.
    2006-04-24
    LUNESTA
    LUNESTA
    78867679 3187447 Live/Registered
    SUNOVION PHARMACEUTICALS INC.
    2006-04-24
    LUNESTA
    LUNESTA
    78315120 3133744 Live/Registered
    SUNOVION PHARMACEUTICALS INC.
    2003-10-17
    LUNESTA
    LUNESTA
    77873063 not registered Dead/Abandoned
    Comfort Revolution, LLC
    2009-11-16

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.