ESZOPICLONE- eszopiclone tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ESZOPICLONE (UNII: UZX80K71OE) (ESZOPICLONE - UNII:UZX80K71OE)

Available from:

REMEDYREPACK INC.

Administration route:

OROPHARYNGEAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Eszopiclone tablets are 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). Eszopiclone tablets are contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema [see Warnings and Precautions ( 5.3)] . Risk Summary Available pharmacovigilance data with eszopiclone use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies conducted in pregnant rats and rabbits throughout or

Product summary:

Eszopiclone 3 mg tablets are round, dark blue, film-coated, and identified with debossed markings of ‘384’ on one side, and ‘G’ on other side and are supplied as: Eszopiclone 2 mg tablets are round, white off-white, film-coated, and identified with debossed markings of ‘383’ on one side, and ‘G’ on other side and are supplied as: Eszopiclone 1 mg tablets are round, light blue, film-coated, and identified with debossed markings of ‘382’ on one side, and ‘G’ on other side and are supplied as: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
REMEDYREPACK INC.
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MEDICATION GUIDE
Eszopiclone (ES-zoe-PIK-lone)
Tablets, Coated C-IV
Read the Medication Guide that comes with eszopiclone tablets before
you start taking them 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 that you may not
know are happening to you. These side
effects include:
•
sleepiness during the day
•
not thinking clearly
•
act strangely, confused, or upset
•
“sleep-walking” or doing other activities when you are asleep
like:
•
eating
•
talking
•
having sex
•
driving a car
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:
•
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 are eszopiclone tablets?
Eszopiclone tablets are a sedative-hypnotic (sleep) medicine.
Eszopiclone tablets are 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 is a federally controlled substance (C-IV) because it ca

Summary of Product characteristics

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESZOPICLONE TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR ESZOPICLONE TABLETS.
ESZOPICLONE TABLETS, FOR ORAL USE, CIV
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
1. Warnings and Precautions, CNS Depressant Effects and Next-Day
Impairment ( 5.1) 12/2018
INDICATIONS AND USAGE
Eszopiclone tablets are indicated for the treatment of insomnia.
Eszopiclone tablets have been shown to decrease sleep
latency and improve sleep maintenance ( 1).
DOSAGE AND ADMINISTRATION
Use the lowest dose effective for the patient ( 2)
Recommended initial dose is 1 mg, immediately before bedtime, with at
least 7 to 8 hours remaining before the planned
time of awakening. May increase dose if clinically indicated, to a
maximum of 3 mg ( 2.1)
Geriatric or debilitated patients: Dose should not exceed 2 mg ( 2.2)
Patients with severe hepatic impairment, or taking potent CYP3A4
inhibitors: Dose should not exceed 2 mg ( 2.3)
Do not take with or immediately after a meal ( 2.5)
DOSAGE FORMS AND STRENGTHS
Tablets: 1 mg, 2 mg, and 3 mg ( 3)
CONTRAINDICATIONS
Known hypersensitivity to eszopiclone ( 4)
WARNINGS AND PRECAUTIONS
_CNS depressant effects:_ Impaired alertness and motor coordination,
including risk of morning impairment. Risk
increases with dose. Caution patients taking 3 mg dose against driving
and against activities requiring complete mental
alertness during the morning after use. ( 5.1)
_Evaluate for Co-Morbid Diagnoses: _Reevaluate if insomnia persists
after 7 to 10 days of use ( 5.2)
_Severe Anaphylactic/Anaphylactoid Reactions _(angioedema and
anaphylaxis have been reported): Do not rechallenge if
such reactions occur ( 5.3)
_Abnormal Thinking, Behavioral Changes (e.g., hallucinations), Complex
Behaviors (e.g., “sleep-driving”): _Immediately
evaluate if occurs ( 5.4)
_Worsening of Depression or Suicidal Thinking _may occur: Presc