ESZOPICLONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ESZOPICLONE (UNII: UZX80K71OE) (ESZOPICLONE - UNII:UZX80K71OE)

Available from:

DIRECT RX

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 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/d

Product summary:

Eszopiclone Tablets are round, white, biconvex, film-coated tablets and are supplied as follows: The 1 mg tablets are debossed with product identification “54” over “746” on one side and plain on the other side. The 2 mg tablets are debossed with product identification “54” over “029” on one side and plain on the other side. The 3 mg tablets are debossed with product identification “54” over “396” on one side and plain on the other side. Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESZOPICLONE- ESZOPICLONE TABLET
DIRECT RX
----------
Eszopiclone Tablets (ES-zoe-PIK-lone), coated CIV
Read the Medication Guide that comes with eszopiclone 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?
•
Do not take more eszopiclone than prescribed
•
Do not take eszopiclone unless you are able to stay in bed a full
night (7 to 8 hours) before you must be
active again
•
Take eszopiclone right before you get in bed, not sooner
Eszopiclone 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.
The morning after you take eszopiclone your ability to drive safely
and think clearly may be decreased.
Do not take eszopiclone 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 with your other
medicines
•
cannot get a full night’s sleep
What is eszopiclone?
Eszopiclone is a sedative-hypnotic (sleep) medicine. Eszopiclone is
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 is not for children.
Eszopiclone is a federally controlled substance (C-IV) because it can
be abused or lead to dependence.
Keep eszopiclone in a safe place to prevent misuse and abuse. Selling
or giving away eszopiclone may
harm others, and is against

Summary of Product characteristics

ESZOPICLONE- ESZOPICLONE TABLET
DIRECT RX
----------
ESZOPICLONE 3MG
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).
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
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 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 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 with potent
CYP3A4 inhibitors, the total dose of eszopiclone should not exceed 2
mg [see Warning and Precautions
(5.7)].
2.4 Use with CNS Depressants
Dosage adjustments may be necessary when eszopiclone 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 with or immediately after a heavy, high-fat meal
results in slower absorption and
would be expected to reduce the effect of eszopiclone on sleep latency
[see Clinical Pharmacology
(12.3)].
Eszopiclone tablets are available as 1 mg, 2 mg,