LUNESTA- eszopiclone tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

eszopiclone (UNII: UZX80K71OE) (eszopiclone - UNII:UZX80K71OE)

Available from:

Rebel Distributors Corp

INN (International Name):

eszopiclone

Composition:

eszopiclone 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LUNESTA is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, LUNESTA 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). None known. LUNESTA is a Schedule IV controlled substance under the Controlled Substances Act. Other substances under the same classification are benzodiazepines and the nonbenzodiazepine hypnotics zaleplon and zolpidem. While eszopiclone is a hypnotic agent with a chemical structure unrelated to benzodiazepines, it shares some of the pharmacologic properties of the benzodiazepines. Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for

Product summary:

LUNESTA 3 mg tablets are round, dark blue, film-coated, and identified with debossed markings of S193 on one side, and are supplied as: LUNESTA 2 mg tablets are round, white, film-coated, and identified with debossed markings of S191 on one side, and are supplied as: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. SEPRACOR Manufactured for: Sepracor Inc. Marlborough, MA 01752 USA For customer service, call 1-888-394-7377. To report adverse events, call 1-877-737-7226. For medical information, call 1-800-739-0565. Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Authorization status:

New Drug Application

Patient Information leaflet

LUNESTA- ESZOPICLONE TABLET, COATED
Rebel Distributors Corp
----------
MEDICATION GUIDE
LUNESTA®(lû'-nes''-tã) Tablets, Coated C-IV
(eszopiclone)
Read the Medication Guide that comes with LUNESTA 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 LUNESTA?
After taking LUNESTA, 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 LUNESTA. 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
LUNESTA.
Important:
1. Take LUNESTA exactly as prescribed
•
Do not take more LUNESTA than prescribed.
•
Take LUNESTA right before you get in bed, not sooner.
2. Do not take LUNESTA 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 LUNESTA with your other
medicines
•
cannot get a full night's sleep
What is LUNESTA?
LUNESTA is a sedative-hypnotic (sleep) medicine. LUNESTA 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
LUNESTA is not for children.
LUNESTA is a federally controlled substance (C-IV) because it can be
abused or lead to dependence.
Keep LUNESTA in a safe place to prevent misuse and abuse. Selling or
giving away LUNESTA may
harm others, and is against the law. Tell your doctor if you have ever
abused or been dependent o

Summary of Product characteristics

LUNESTA- ESZOPICLONE TABLET, COATED
REBEL DISTRIBUTORS CORP
----------
LUNESTA (ESZOPICLONE) TABLETS
1 MG, 2 MG, 3 MG
RX ONLY
C-IV
PRESCRIBING INFORMATION
DESCRIPTION:
LUNESTA (eszopiclone) is a nonbenzodiazepine hypnotic agent that is a
pyrrolopyrazine derivative of
the cyclopyrrolone class. The chemical name of eszopiclone is
(+)-(5S)-6-(5-chloropyridin-2-yl)-7-
oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl
4-methylpiperazine-1-carboxylate. Its molecular
weight is 388.81, and its empirical formula is C
H ClN O . Eszopiclone has a single chiral center
with an (_S_)-configuration. It has the following chemical structure:
Eszopiclone is a white to light-yellow crystalline solid. Eszopiclone
is very slightly soluble in water,
slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2).
Eszopiclone is formulated as film-coated tablets for oral
administration. LUNESTA tablets contain 1
mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients:
calcium phosphate, colloidal
silicon dioxide, croscarmellose sodium, hypromellose, lactose,
magnesium stearate, microcrystalline
cellulose, polyethylene glycol, titanium dioxide, and triacetin. In
addition, both the 1 mg and 3 mg tablets
contain FD&C Blue #2.
CLINICAL PHARMACOLOGY:
PHARMACODYNAMICS
The precise mechanism of action of eszopiclone as a hypnotic is
unknown, but its effect is believed to
result from its interaction with GABA-receptor complexes at binding
domains located close to or
allosterically coupled to benzodiazepine receptors. Eszopiclone is a
nonbenzodiazepine hypnotic that is
a pyrrolopyrazine derivative of the cyclopyrrolone class with a
chemical structure unrelated to
pyrazolopyrimidines, imidazopyridines, benzodiazepines, barbiturates,
or other drugs with known
hypnotic properties.
PHARMACOKINETICS
The pharmacokinetics of eszopiclone have been investigated in healthy
subjects (adult and elderly) and
in patients with hepatic disease or renal disease. In healthy
subjects, the pharmacokinetic profile was
examined after single doses of u