ZOLPIDEM TARTRATE tablet, film coated, extended release

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

ZOLPIDEM TARTRATE (UNII: WY6W63843K) (ZOLPIDEM - UNII:7K383OQI23)

Tersedia dari:

Sun Pharmaceutical Industries, Inc.

INN (Nama Internasional):

ZOLPIDEM TARTRATE

Komposisi:

ZOLPIDEM TARTRATE 6.25 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Zolpidem tartrate extended-release tablets, USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see Clinical Studies (14)] .  Zolpidem tartrate extended-release tablets are contraindicated in patients - who have experienced complex sleep behaviors after taking zolpidem tartrate extended-release tablets [see Warnings and Precautions (5.1)]. - with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.4)]. Risk Summary Neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation [see

Ringkasan produk:

Zolpidem tartrate extended-release tablets, USP, 6.25 mg are round biconvex bi-layer coated tablets with pink layer and white layer and imprinted with “307” on one side and plain on other side. Zolpidem tartrate extended-release tablets, USP, 6.25 mg are supplied as follows: Bottles of 100 with Child Resistant Cap ………………..…... NDC 47335-307-88 Bottles of 500 .................................................…………..…... NDC 47335-307-13 Zolpidem tartrate extended-release tablets, USP, 12.5 mg are round biconvex bi-layer coated tablets with yellow layer and white layer and imprinted with “308” on one side and plain on other side. Zolpidem tartrate extended-release tablets, USP, 12.5 mg are supplied as follows: Bottles of 100 with Child Resistant Cap ………………..…... NDC 47335-308-88 Bottles of 500  ................................................…………..…... NDC 47335-308-13 Storage: Store zolpidem tartrate extended-release tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature ]. 

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE
Dispense with Medication Guide available at:
https://www.sunpharma.com/usa/products
MEDICATION GUIDE
Zolpidem Tartrate (zole-PI-dem TAR-trate) Extended-Release Tablets,
USP C-IV
What is the most important information I should know about zolpidem
tartrate extended-release tablets?
Zolpidem
tartrate
extended-release
tablets
may
cause
serious
side
effects,
including:
· Complex sleep behaviors. After taking zolpidem tartrate
extended-release 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.
These activities may happen with
zolpidem tartrate extended-release tablets whether or not you drink
alcohol or take other medicines that
make you sleepy. Some of these complex sleep behaviors have caused
serious injury and death. People
taking zolpidem tartrate extended-release tablets have reported:
•
sleep-walking
•
sleep-driving
•
making and eating food
•
talking on the phone
•
having sex
Stop taking zolpidem tartrate extended-release tablets and tell your
healthcare provider right away if you
find out that you have done any of the above activities after taking
zolpidem tartrate extended-release
tablets.
What is zolpidem tartrate extended-release tablets?
Zolpidem tartrate extended-release tablets is a prescription sleep
medicine used for the treatment of adults
who have trouble falling asleep or staying asleep (insomnia).
· It is not known if zolpidem tartrate extended-release tablets is
safe and effective in children under
the age of 18 years. Zolpidem tartrate extended-release tablets is not
recommended for use in children
under the age of 18 years.
Zolpidem tartrate extended-release tablets is a federally controlled
substance (C-IV) because it can be
abused or lead to dependence. Keep zolpidem tartrate extended-release
tablets in a safe place to protect it
from theft. Never give your zolpidem tartrate ex

Karakteristik produk

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED
RELEASE
SUN PHARMACEUTICAL INDUSTRIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLPIDEM TARTRATE
EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS.
ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS, FOR ORAL USE, C-IV
INITIAL U.S. APPROVAL: 1992
WARNING: COMPLEX SLEEP BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
COMPLEX SLEEP BEHAVIORS INCLUDING SLEEP-WALKING, SLEEP-DRIVING, AND
ENGAGING IN OTHER
ACTIVITIES WHILE NOT FULLY AWAKE MAY OCCUR FOLLOWING USE OF ZOLPIDEM
TARTRATE EXTENDED-
RELEASE TABLETS. SOME OF THESE EVENTS MAY RESULT IN SERIOUS INJURIES,
INCLUDING DEATH.
DISCONTINUE ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS IMMEDIATELY IF
A PATIENT
EXPERIENCES A COMPLEX SLEEP BEHAVIOR. (4, 5.1)
INDICATIONS AND USAGE
Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor
positive modulator, is indicated for the
short-term treatment of insomnia characterized by difficulties with
sleep onset and/or sleep maintenance.
(1)
DOSAGE AND ADMINISTRATION
Use the lowest dose effective for the patient and must not exceed a
total of 12.5 mg daily (2.1)
Treatment should be as short as possible (2.1)
Recommended initial dose is a single dose of 6.25 mg for women and a
single dose of 6.25 mg or 12.5
mg for men, immediately before bedtime with at least 7 to 8 hours
remaining before the planned time
of awakening (2.1)
Geriatric patients and patients with mild to moderate hepatic
impairment: Recommended dose is 6.25
mg for men and women (2.2)
Lower doses of CNS depressants may be necessary when taken
concomitantly with zolpidem tartrate
extended-release tablets (2.3)
Tablets to be swallowed whole, not to be crushed, divided or chewed
(2.4)
The effect of zolpidem tartrate extended-release tablets may be slowed
if taken with or immediately
after a meal (2.4)
DOSAGE FORMS AND STRENGTHS
E