LUNESTA- eszopiclone 3mg tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ESZOPICLONE (UNII: UZX80K71OE) (ESZOPICLONE - UNII:UZX80K71OE)
Available from:
Advanced Rx Pharmacy of Tennessee, LLC
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
1 INDICATIONS AND USAGE Eszopiclone tablet is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).
Authorization status:
Abbreviated New Drug Application
Authorization number:
80425-0115-1

Read the complete document

LUNESTA- eszopiclone 3mg tablet, film coated

Advanced Rx Pharmacy of Tennessee, LLC

----------

Medication Guide Section

MEDICATION GUIDE[Image 2]

Rx only

Read the Medication Guide that comes with eszopiclone tablets 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 tablets?

Do not take more eszopiclone tablets than prescribed.

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

must be active again.

Take eszopiclone tablets right before you get in bed, not sooner.

Eszopiclone tablets may cause serious side effects, including:

Complex sleep behaviors that have caused serious injury and death. After taking 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

(complex sleep behaviors). The next morning, you may not remember that you did anything during the

night. These activities may occur with eszopiclone tablets 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 eszopiclone tablets and call your healthcare provider right away if you find out that you have

done any of the above activities after taking eszopiclone tablets.

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

decreased.

Do not take eszopiclone tablets 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 eszopiclone tablets

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 eszopiclone tablets with your other medicines.

cannot get a full night's sleep

WHAT IS ESZOPICLONE TABLET?

Eszopiclone tablet is a sedative-hypnotic (sleep) medicine. Eszopiclone tablet 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

Eszopiclone tablets are not for children.

Eszopiclone tablet is a federally controlled substance (C-IV) because it can be abused or lead to

dependence. Keep eszopiclone tablets in a safe place to prevent misuse and abuse. Selling or giving away

eszopiclone tablets 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 tablets?

Do not take eszopiclone tablets if you have ever had a complex sleep behavior happen after taking

eszopiclone tablets.

Do not take eszopiclone tablets if you are allergic to anything in it. See the end of this Medication Guide

for a complete list of ingredients in eszopiclone tablets.

Eszopiclone tablets may not be right for you. Before starting eszopiclone tablets, 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 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 tablets?

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

you.

Take eszopiclone tablets right before you get into bed.

Do not take eszopiclone tablets with or right after a meal.

Do not take eszopiclone tablets 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 eszopiclone tablets or overdose, call your doctor or poison control center right away,

or get emergency treatment.

What are the possible side effects of eszopiclone tablets?

Possible serious side effects of eszopiclone tablets include:

getting out of bed while not being fully awake and do an activity that you doing not know you are doing.

(See "What is the most important information I should know about eszopiclone tablets?")

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 eszopiclone

tablets.

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 tablets.

The most common side effects of eszopiclone tablets 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 eszopiclone tablets. Do not drive or do other

dangerous activities after taking eszopiclone tablets until you feel fully awake.

These are not all the side effects of eszopiclone tablets. 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. You may also report side effects to Lupin Pharmaceuticals, Inc. at 1-800-399-2561.

How should I store eszopiclone tablets?

Store eszopiclone tablets at room temperature, between 59oF to 86oF (15oC to 30oC).

Do not use eszopiclone tablets after the expiration date.

Keep eszopiclone tablets and all medicines out of reach of children.

General Information about eszopiclone tablets

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

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

Do not share eszopiclone tablets 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 tablets. If you

would like more information, talk with your doctor. You can ask your doctor or pharmacist for

information about eszopiclone tablets that is written for healthcare professionals.

To report side effects, call 1-800-399-2561.

What are the ingredients in eszopiclone tablets?

Active Ingredient: eszopiclone

Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate

dihydrate, hypromellose, lactose monohydrate, polyethylene glycol, povidone, pregelatinized starch,

magnesium stearate and titanium dioxide. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue

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

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Goa 403 722

INDIA

Revised: October 2019 ID#: 262264

Revised: 12/2020

Document Id: b5a745c6-e00e-7d08-e053-2995a90a8558

34391-3

Set id: b4f272eb-02e3-415a-e053-2a95a90a428f

Version: 2

Effective Time: 20201204

Advanced Rx Pharmacy of Tennessee, LLC

Read the complete document

LUNESTA- eszopiclone 3mg tablet, film coated

Advanced Rx Pharmacy of Tennessee, LLC

----------

Eszopiclone 3mg tablets # 30

Medication Guide Section

MEDICATION GUIDE[Image 2]

Rx only

Read the Medication Guide that comes with eszopiclone tablets 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 tablets?

Do not take more eszopiclone tablets than prescribed.

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

must be active again.

Take eszopiclone tablets right before you get in bed, not sooner.

Eszopiclone tablets may cause serious side effects, including:

Complex sleep behaviors that have caused serious injury and death. After taking 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 (complex sleep behaviors). The next morning, you may not remember that you did anything during

the night. These activities may occur with eszopiclone tablets 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 eszopiclone tablets and call your healthcare provider right away if you find out that you

have done any of the above activities after taking eszopiclone tablets.

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

decreased.

Do not take eszopiclone tablets 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 eszopiclone tablets

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 eszopiclone tablets with your other medicines.

cannot get a full night's sleep

WHAT IS ESZOPICLONE TABLET?

Eszopiclone tablet is a sedative-hypnotic (sleep) medicine. Eszopiclone tablet 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

Eszopiclone tablets are not for children.

Eszopiclone tablet is a federally controlled substance (C-IV) because it can be abused or lead to

dependence. Keep eszopiclone tablets in a safe place to prevent misuse and abuse. Selling or giving

away eszopiclone tablets 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 tablets?

Do not take eszopiclone tablets if you have ever had a complex sleep behavior happen after taking

eszopiclone tablets.

Do not take eszopiclone tablets if you are allergic to anything in it. See the end of this Medication

Guide for a complete list of ingredients in eszopiclone tablets.

Eszopiclone tablets may not be right for you. Before starting eszopiclone tablets, 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 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 tablets?

Take eszopiclone tablets exactly as prescribed. Do not take more eszopiclone tablets than prescribed

for you.

Take eszopiclone tablets right before you get into bed.

Do not take eszopiclone tablets with or right after a meal.

Do not take eszopiclone tablets 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 eszopiclone tablets or overdose, call your doctor or poison control center right

away, or get emergency treatment.

What are the possible side effects of eszopiclone tablets?

Possible serious side effects of eszopiclone tablets include:

getting out of bed while not being fully awake and do an activity that you doing not know you are doing.

(See "What is the most important information I should know about eszopiclone tablets?")

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 eszopiclone

tablets.

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 tablets.

The most common side effects of eszopiclone tablets 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 eszopiclone tablets. Do not drive or do other

dangerous activities after taking eszopiclone tablets until you feel fully awake.

These are not all the side effects of eszopiclone tablets. 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. You may also report side effects to Lupin Pharmaceuticals, Inc. at 1-800-

399-2561.

How should I store eszopiclone tablets?

Store eszopiclone tablets at room temperature, between 59oF to 86oF (15oC to 30oC).

Do not use eszopiclone tablets after the expiration date.

Keep eszopiclone tablets and all medicines out of reach of children.

General Information about eszopiclone tablets

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

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

Do not share eszopiclone tablets 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 tablets. If you

would like more information, talk with your doctor. You can ask your doctor or pharmacist for

information about eszopiclone tablets that is written for healthcare professionals.

To report side effects, call 1-800-399-2561.

What are the ingredients in eszopiclone tablets?

Active Ingredient: eszopiclone

Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate

dihydrate, hypromellose, lactose monohydrate, polyethylene glycol, povidone, pregelatinized starch,

magnesium stearate and titanium dioxide. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue

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

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Goa 403 722

INDIA

Revised: October 2019 ID#: 262264

Dosage and Administration Section

2 DOSAGE AND ADMINISTRATION

Use the lowest effective dose for the patient.

2.1 Dosage in Adults

The recommended starting dose is 1 mg. Dosing can be raised to 2 mg or 3 mg if clinically indicated. In

some patients, the higher morning blood levels of eszopiclone following use of the 2 mg or 3 mg dose

increase the risk of next day impairment of driving and other activities that require full alertness [see

WARNINGS AND PRECAUTIONS (5.1)]. The total dose of eszopiclone should not exceed 3 mg,

once daily immediately before bedtime [see WARNINGS AND PRECAUTIONS (5.6)].

2.2 Geriatric or Debilitated Patients

The total dose of eszopiclone tablets should not exceed 2 mg in elderly or debilitated patients.

2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors

In patients with severe hepatic impairment, or in patients coadministered eszopiclone with potent

CYP3A4 inhibitors, the total dose of eszopiclone tablets should not exceed 2 mg [see WARNING

AND PRECAUTIONS (5.7)].

2.4 Use with CNS Depressants

Dosage adjustments may be necessary when eszopiclone tablets are combined with other central

nervous system (CNS) depressant drugs because of the potentially additive effects [see WARNINGS

AND PRECAUTIONS (5.1)].

2.5 Administration with Food

Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption

and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see CLINICAL

PHARMACOLOGY (12.3)].

Indications and Usage Section

1 INDICATIONS AND USAGE

Eszopiclone tablet is indicated for the treatment of insomnia. In controlled outpatient and sleep

laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved

sleep maintenance.

The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal

assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults

only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).

Principal Display Panel

LUNESTA

eszopiclone 3mg tablet, film coated

Product Information

Product T ype

HUMAN

PRESCRIPTION DRUG

Ite m Code (Source )

NDC:8 0 425-

0 115(NDC:6 8 18 0 -324)

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ESZO PICLO NE (UNII: UZX8 0 K71OE) (ESZOPICLONE - UNII:UZX8 0 K71OE)

ESZOPICLONE

3 mg

Product Characteristics

Color

blue

S core

no sco re

S hap e

ROUND

S iz e

6 mm

Flavor

Imprint Code

LU;Y23

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:8 0 425-0 115-1

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 4/15/20 14

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 9 1124

0 4/15/20 14

Labeler -

Advanced Rx Pharmacy of T ennessee, LLC (117023142)

Advanced Rx Pharmacy of Tennessee, LLC

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Advanced Rx Pharmacy o f Tennessee, LLC

1170 23142

re pa c k(8 0 425-0 115)

Revised: 12/2020

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