ESZOPICLONE- 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:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

ESZOPICLONE

Composition:

ESZOPICLONE 2 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 tablets are contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.2)] . 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 rabbits (4, 8, or 16 mg/kg

Product summary:

Eszopiclone tablets are available as follows: Eszopiclone 1 mg tablets are light-blue, film-coated, convex, round tablets, debossed “93” on one side of the tablet and “E7” on the other side, in bottles of 30. NDC 42291-271-30 Eszopiclone 2 mg tablets are white, film-coated, convex, round tablets, debossed “93” on one side of the tablet and “E8” on the other side, in bottles of 90. NDC 42291-272-90 Eszopiclone 3 mg tablets are blue, film-coated, convex, round tablets, debossed “93” on one side of the tablet and “E9” on the other side, in bottles of 90. NDC 42291-273-90 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, FILM COATED
Aphena Pharma Solutions - Tennessee, LLC
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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?
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. The next morning, you may not
remember that you did anything
during the night. You have a higher chance for doing these activities
if you drink alcohol or take other
medicines that make you sleepy with eszopiclone tablets. Reported
activities include:
•
driving a car ("sleep-driving")
•
making and eating food
•
talking on the phone
•
having sex
•
sleep-walking
Call your doctor right away if you find out that you have done any of
the above activities after taking
eszopiclone tablets.
Important:
1. Take eszopiclone tablets exactly as prescribed
•
Do not take more eszopiclone tablets than prescribed.
•
Take eszopiclone tablets right before you get in bed, not sooner.
2. Do not take eszopiclone tablets if you:
•
drink alcohol
•
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 tablets are a federally controlled substance (C-IV)
because it can be abused or lead

Summary of Product characteristics

ESZOPICLONE - ESZOPICLONE TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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
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
_Non-Elderly Adults:_ 2 mg starting dose immediately before bedtime.
May start or increase to 3 mg if clinically indicated
since 3 mg is more effective for sleep maintenance (2.1)
_Elderly:_ For difficulty falling asleep 1 mg immediately before
bedtime. For difficulty staying asleep 2 mg immediately
before bedtime (2.1)
_Severe Hepatic Impairment:_ Starting dose 1 mg (2.1)
_Patients Taking Concomitant Potent CYP3A4 Inhibitors:_ Do not exceed
a 1 mg starting dose. Maximum dose is 2 mg
(2.1)
Do not take with or immediately after a meal (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 1 mg, 2 mg, and 3 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to eszopiclone (4)
WARNINGS AND PRECAUTIONS
_Evaluate for Co-Morbid Diagnoses:_ Reevaluate if insomnia persists
after 7 to 10 days of use (5.1)
_Severe Anaphylactic/Anaphylactoid Reactions (angioedema and
anaphylaxis have been reported):_ Do not rechallenge if
such reactions occur (5.2)
_Abnormal Thinking, Behavioral Changes (e.g., hallucinations, Complex
Behaviors (e.g., “sleep-driving”):_ Immediately
evaluate if occurs (5.3)
_Worsening of Depression or Suicidal Thinking_ may occur: Prescribe
the least number of tablets feasible to avoid
intentional overdose (5.3, 5.7)
_Withdrawal Effects_ (symptoms may occur with rapid dose reduction or
discontinuation) (5.4, 9.3)
_CNS Depressant Effects:_ Use can impair alertness and motor
coordination. If used in combination with other CNS
depressants, dose reductions