Lunesta (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

LUNESTA 3 mg tablets are round, dark blue, film-coated, and identified with debossed markings of S193 on one side, and are supplied as:

NDC 63402-193-10 bottle of 100 tablets
NDC 63402-193-03 bottle of 30 tablets

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

NDC 63402-191-03 bottle of 30 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].

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Medication Guide).

Inform patients and their families about the benefits and risks of treatment with LUNESTA. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with LUNESTA and with each prescription refill. Review the LUNESTA Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that LUNESTA should be taken only as prescribed.

Complex Sleep Behaviors

Instruct patients and their families that LUNESTA may cause complex sleep behaviors, including sleep-walking, sleep-driving, preparing and eating food, making phone calls, or having sex while not being fully awake. Serious injuries and death have occurred during complex sleep behavior episodes. Tell patients to discontinue LUNESTA and notify their healthcare provider immediately if they develop any of these symptoms [see Boxed Warning, Warnings and Precautions (5.1)].

CNS Depressant Effects and Next-Day Impairment

Tell patients that LUNESTA can cause next-day impairment even when used as prescribed, and that this risk is increased if dosing instructions are not carefully followed. Caution patients taking the 3 mg dose against driving and other activities requiring complete mental alertness the day after use. Inform patients that impairment can be present despite feeling fully awake. Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients [see Warnings and Precautions (5.2)].

Severe Anaphylactic and Anaphylactoid Reactions

Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with eszopiclone. Describe the signs/symptoms of these reactions and advise patients to seek medical attention immediately if any of them occur [see Warnings and Precautions (5.4)].

Suicide

Tell patients to immediately report any suicidal thoughts.

Alcohol and Other Drugs

Ask patients about alcohol consumption, medicines they are taking, and drugs they may be taking without a prescription. Advise patients not to use LUNESTA if they drank alcohol that evening or before bed.

Tolerance, Abuse, and Dependence

Tell patients not to increase the dose of LUNESTA on their own, and to inform you if they believe the drug “does not work.”

Administration Instructions

Patients should be counseled to take LUNESTA right before they get into bed and only when they are able to stay in bed a full night (7–8 hours) before being active again. LUNESTA tablets should not be taken with or immediately after a meal. Advise patients NOT to take LUNESTA if they drank alcohol that evening.

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

© 2019 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?

• Do not take more LUNESTA than prescribed.
• Do not take LUNESTA unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again.
• Take LUNESTA right before you get in bed, not sooner.

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:

• doing activities when you are asleep like:
  • making and eating food
  • talking on the phone
  • having sex
  • driving a car (“sleep-driving”)
  • sleep walking

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:

• have ever experienced a complex sleep behavior (such as driving a car, making and eating food, talking on the phone or having sex while not fully awake) after taking LUNESTA
• drank alcohol that evening or before bed
• 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 have ever had a complex sleep behavior happen after taking 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 doing 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, acting strangely, 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. 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.

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

© 2019 Sunovion Pharmaceuticals Inc. All rights reserved.
LUNESTA is a registered trademark of Sunovion Pharmaceuticals Inc.
Revised: 08/201910161-03

1 MG BOTTLE LABEL – PRINCIPAL DISPLAY PANEL – 1mg

NDC 63402-190-30

30 Tablets

Lunesta^®

(eszopiclone) Tablets

1 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

NDC 63402-191-03

30 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

3 MG BOTTLE LABEL – PRINCIPAL DISPLAY PANEL – 3mg

NDC 63402-193-03

30 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

LUNESTA eszopiclone tablet, coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63402-190 Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESZOPICLONE (ESZOPICLONE) ESZOPICLONE 1 mg

Inactive Ingredients Ingredient Name Strength CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE TRIACETIN FD&C BLUE NO. 2

Product Characteristics Color BLUE (light blue) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code S190 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63402-190-30 30 TABLET, COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021476 04/04/2005

LUNESTA eszopiclone tablet, coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63402-191 Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESZOPICLONE (ESZOPICLONE) ESZOPICLONE 2 mg

Inactive Ingredients Ingredient Name Strength CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE TRIACETIN

Product Characteristics Color white (white) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code S191 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63402-191-03 30 TABLET, COATED in 1 BOTTLE None 2 NDC:63402-191-10 100 TABLET, COATED in 1 BOTTLE None 3 NDC:63402-191-30 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK (63402-191-01) 3 NDC:63402-191-01 1 TABLET, COATED in 1 BLISTER PACK This package is contained within the CARTON (63402-191-30)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021476 04/04/2005

LUNESTA eszopiclone tablet, coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63402-193 Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ESZOPICLONE (ESZOPICLONE) ESZOPICLONE 3 mg

Inactive Ingredients Ingredient Name Strength CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE TRIACETIN FD&C BLUE NO. 2

Product Characteristics Color BLUE (dark blue) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code S193 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63402-193-03 30 TABLET, COATED in 1 BOTTLE None 2 NDC:63402-193-10 100 TABLET, COATED in 1 BOTTLE None 3 NDC:63402-193-30 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK (63402-193-01) 3 NDC:63402-193-01 1 TABLET, COATED in 1 BLISTER PACK This package is contained within the CARTON (63402-193-30)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021476 04/04/2005

Labeler — Sunovion Pharmaceuticals Inc. (131661746)

Revised: 09/2021 Sunovion Pharmaceuticals Inc.