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:

Lake Erie Medical DBA Quality Care Products LLC

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 tablets are 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 administration of eszopiclone to pregnant rats (62.5, 125, or 250 mg/kg/day) and rabbi

Product summary:

Eszopiclone 3 mg tablets are dark blue, round, biconvex, film coated tablet, debossed with "L 36" on one side and plain on other side. Eszopiclone 2 mg tablets are white, round, biconvex, film coated tablet, debossed with "L 35" on one side and plain on other side. Eszopiclone 1 mg tablets are light blue, round, biconvex, film coated tablet, debossed with "L 34" on one side and plain on other side. 55700-621-30 Store at room temperature 20°C  to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
Lake Erie Medical DBA Quality Care Products LLC
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SPL MEDGUIDE SECTION
MEDICATION GUIDE
Eszopiclone Tablets, Coated 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:
o eating
o talking
o having sex
o 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 IS ESZOPICLONE?
Eszopiclone is a sedative-hypnotic (sleep) medicine. Eszopiclone 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 is not for children.
Eszopiclone is a federally controlled substance (C-IV) because it ca

Summary of Product characteristics

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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
Dosage and Administration (2) 5/2014
Warnings and Precautions (5) 5/2014
Studies Pertinent to Safety Concerns for Sedative 5/2014
Hypnotic Drugs (14.3)
INDICATIONS AND USAGE
Eszopiclone tablets are indicated for the treatment of insomnia.
Eszopiclone tablets has 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 7-8 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”):_ Immediat