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:

Proficient Rx LP

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)] . 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 rabbits (4, 8, or 16 mg/kg/day) thr

Product summary:

Eszopiclone tablets, 1 mg, are light blue colored, biconvex, round shaped film coated, debossed with “E” on one side and “1” on other side and are supplied as: NDC 63187-579-30         bottle of 30 tablets NDC 63187-579-60         bottle of 60 tablets NDC 63187-579-90         bottle of 90 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].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
Proficient Rx LP
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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
PROFICIENT RX LP
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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 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) (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 1 mg, 2 mg, and 3 mg (3) (3)
CONTRAINDICATIONS
Known hypersensitivity to eszopiclone (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
ADVERSE REACTIONS
Most commonly observed adverse reactions (incidence ≥2%) were
unpleasant taste, headache, somnolence, respiratory
infection, dizziness, dry mouth, rash, anxiety, hallucinations, and
viral infections (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PROSAR AT 866-562-4590
OR FDA AT 1-800-FDA-1088
OR WWW.FDA.GOV/MEDWATCH. (6)
DRUG INTERACTIONS
•
•
•
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)
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 th