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:

DirectRX

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 Teratogenic Effects: 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, 12

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESZOPICLONE- ESZOPICLONE TABLET, FILM COATED
DirectRX
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SPL MEDGUIDE SECTION
•
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
DIRECTRX
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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 are
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