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:

DIRECT RX

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)]. 8.1 Pregnancy 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

Product summary:

Eszopiclone tablets 1 mg are blue colored, circular, film-coated tablets, debossed with ‘S’ on one side and ‘1’ on other side. Bottles of 30’s with Child Resistant Cap……………..NDC 47335-586-83 Bottles of 100’s with Child Resistant Cap……………NDC 47335-586-88 Bottles of 100’s with Non Child Resistant Cap………NDC 47335-586-08 Bottles of 1000’s with Non Child Resistant Cap……..NDC 47335-586-18 Eszopiclone tablets 2 mg are white colored, circular, film-coated tablets, debossed with ‘S’ on one side and ‘2’ on other side. Bottles of 30’s with Child Resistant Cap……………..NDC 47335-587-83 Bottles of 100’s with Child Resistant Cap……………NDC 47335-587-88 Bottles of 100’s with Non Child Resistant Cap………NDC 47335-587-08 Bottles of 1000’s with Non Child Resistant Cap……..NDC 47335-587-18 Eszopiclone tablets 3 mg are dark blue colored, circular, film-coated tablets, debossed with ‘S’ on one side and ‘3’ on other side. Bottles of 30’s with Child Resistant Cap……………..NDC 47335-588-83 Bottles of 100’s with Child Resistant Cap……………NDC 47335-588-88 Bottles of 100’s with Non Child Resistant Cap………NDC 47335-588-08 Bottles of 1000’s with Non Child Resistant Cap……..NDC 47335-588-18 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in tight container with child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
DIRECT RX
----------
SPL MEDGUIDE SECTION
Eszopiclone Tablets, 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: 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 aresedative-hypnotic (sleep) medicines.Eszopiclone
tablets areused 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 can
be abused or lead to dependence.
Keep eszopiclone tablets in a safe place to pr

Summary of Product characteristics

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
DIRECT RX
----------
ESZOPICLONE
INDICATIONS & USAGE SECTION
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).
DOSAGE & ADMINISTRATION SECTION
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 impairment, or in patients
coadministered eszopiclone tablets with potent
CYP3A4 inhibitors, the total dose of eszopiclone tablets should not
exceed 2 mg [see Warning and
Precautions (5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone tablets is
combined with other CNS depressant
drugs because of the potentially additive effects [see Warnings and
Precautions (5.1)].
2.5 Administration with Food
Taking eszopiclone tablets with or immediately after a heavy, high-fat
meal results in slower absorption
and would be expected to reduce the