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:

Glenmark Pharmaceuticals Inc. USA

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). 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 organogenesis, there was no evidence of teratogenicity. Administration of eszopiclone to rats throughout pregnancy and lactation resulted in offspring toxicities at all doses tested; the lowest dose wa

Product summary:

Eszopiclone Tablets, USP, 3 mg are round, dark blue, film-coated, and identified with debossed markings of ‘384’ on one side, and ‘G’ on the other side and are supplied as: Eszopiclone Tablets, USP, 2 mg are round, white to off-white, film-coated, and identified with debossed markings of ‘383’ on one side, and ‘G’ on the other side and are supplied as: Eszopiclone Tablets, USP, 1 mg are round, light blue, film-coated, and identified with debossed markings of ‘382’ on one side, and ‘G’ on the other side and are supplied as: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°F 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
Glenmark Pharmaceuticals Inc. USA
----------
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 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:
o making and eating food
o talking on the phone
o having sex
o driving a car (“sleep-driving”)
o 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.
�

Summary of Product characteristics

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
GLENMARK PHARMACEUTICALS INC. USA
----------
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 TABLETS. SOME
OF THESE EVENTS MAY RESULT IN SERIOUS INJURIES, INCLUDING DEATH.
DISCONTINUE ESZOPICLONE
TABLETS IMMEDIATELY IF A PATIENT EXPERIENCES A COMPLEX SLEEP BEHAVIOR
(4, 5.1).
RECENT MAJOR CHANGES
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
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 1 mg, 2 mg, and 3 mg (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
Boxed Warning
08/2019
Contraindications
(4) 08/2019
Warnings and Precautions, Complex Sleep Behaviors
(5.1) 08/2019
Warnings and Precautions, CNS Depressant Effects and Next-Day
Impairment (5.2) 12/2018
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)
Patients who have experienced complex sleep behaviors after taking
eszopiclone tablets (_4_)
Known hypersensitivity to eszopiclone (_4_)
_CNS Depressant Effects:_ Impaired alertn