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:

Bryant Ranch Prepack

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 who have experienced complex sleep behaviors after taking Eszopiclone tablets [see Warnings and Precautions (5.1)]. - 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-asso

Product summary:

Eszopiclone Tablets USP 1 mg are light blue colored, film-coated, round shaped, biconvex tablets with debossed ‘K’ on one side and ‘83’ on other side. NDC: 71335-9659-1: 30 Tablets in a BOTTLE NDC: 71335-9659-2: 60 Tablets in a BOTTLE NDC: 71335-9659-3: 90 Tablets in a BOTTLE NDC: 71335-9659-4: 10 Tablets in a BOTTLE NDC: 71335-9659-5: 120 Tablets in a BOTTLE NDC: 71335-9659-6: 100 Tablets in a BOTTLE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Bryant Ranch Prepack
----------
MEDICATION GUIDE
Eszopiclone Tablets USP CIV
(es-zoe’-pi-klone)
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, 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. You also may experience sleepiness during the day.
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
•
t

Summary of Product characteristics

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
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
WARNING: COMPLEX SLEEP BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
COMPLEX SLEEP BEHAVIORS INCLUDING SLEEP-WALKING, SLEEP-DRIVING, AND
ENGAGING IN OTHER
ACTIVITIES WHILE NOT FULLY AWAKE MAY OCCUR FOLLOWING USE OF
ESZOPICLONE. SOME OF THESE
EVENTS MAY RESULT IN SERIOUS INJURIES, INCLUDING DEATH. DISCONTINUE
ESZOPICLONE
IMMEDIATELY IF A PATIENT EXPERIENCES A COMPLEX SLEEP BEHAVIOR (4,
5.1).
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 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
Patients who have experienced complex sleep behaviors after taking
eszopiclone tablets (4)
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 and use with other CNS
depressants and alcohol. Caution
patients taking 3 mg dose against driving and against activities
requiring complete mental alertness
during the morning after use. (5.2)
_Evaluate for Comor