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:

Advanced Rx Pharmacy of Tennessee, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INDICATIONS & USAGE 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)]. 8.1 Pregnancy Risk Summary Available pharmacovigilance data with eszopiclone use in pregnant women a

Product summary:

Eszopiclone tablets, USP 1 mg are light blue, round, biconvex, film coated tablet, debossed with "L 34" on one side and plain on other side. Bottles of 30: NDC 80425-0168-01 Bottles of 60: NDC 80425-0168-02 Bottles of 90: NDC 80425-0168-03 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]. Preserve in tight containers.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
Advanced Rx Pharmacy of Tennessee, LLC
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MEDICATION GUIDE SECTION
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, 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 no

Summary of Product characteristics

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
ADVANCED RX PHARMACY OF TENNESSEE, LLC
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ESZOPICLONE 1MG TABLETS
BOXED WARNING
WARNING: COMPLEX SLEEP BEHAVIORS
WARNING: COMPLEX SLEEP BEHAVIORS
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
[see Contraindications (4) and Warnings and Precautions (5.1)]
1. INDICATIONS AND USAGE SECTION
INDICATIONS & USAGE
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).
2. DOSAGE AND ADMINISTRATION SECTION
DOSAGE & ADMINISTRATION
Use the lowest effective dose for the patient.
2.1 Dosage in Adults
The recommended starting dose is 1 mg. Dosing can be raised to 2 mg or
3 mg if
clinically indicated. In some patients, the higher morning blood
levels of eszopiclone
tablets following use of the 2 mg or 3 mg dose increase the risk of
next day impairment
of driving and other activities that require full alertness [see
Warnings and Precautions
(5.1)]. The total dose of eszopiclone tablets should not exceed 3 mg,
once daily
immediately before bedtime [see Warnings and Precautions (5.6)].
2.2 Geriatric or Debilitated Patients
The total dose of eszopiclone tablets should not exceed 2 mg in
elderly or debilitated
patients.
2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4
Inhibitors
In patients with severe hepatic impairm