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:

Medsource Pharmaceuticals

INN (International Name):

ESZOPICLONE

Composition:

ESZOPICLONE 1 mg

Administration route:

ORAL

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 is contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema [see Warnings and Precautions ( 5.3)] . Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Eszopiclone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral a

Product summary:

Eszopiclone tablets 1 mg are blue colored, circular, film-coated tablets, debossed with ‘S’ on one side and ‘1’ on other side. Eszopiclone tablets 2 mg are white colored, circular, film-coated tablets, debossed with ‘S’ on one side and ‘2’ on other side. Eszopiclone tablets 3 mg are dark blue colored, circular, film-coated tablets, debossed with ‘S’ on one side and ‘3’ on other side. 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]. Dispense in tight container with child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
Medsource Pharmaceuticals
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MEDICATION GUIDE
Eszopiclone Tablets, C-IV
(ES-zoe-PIK-lone)
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 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 aresedative-hypnotic (sleep) medicines.Eszopiclone
tablets areused 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 can
be

Summary of Product characteristics

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
MEDSOURCE PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESZOPICLONE SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR ESZOPICLONE TABLETS.
ESZOPICLONE TABLETS, FOR ORAL USE, CIV
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Dosage and Administration ( 2) 5/2014
Warnings and Precautions ( 5) 5/2014
Studies Pertinent to Safety Concerns for Sedative Hypnotic Drugs (
14.3) 5/2014
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)
_Wo