AMBIEN CR- zolpidem tartrate tablet, coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

sanofi-aventis U.S. LLC

INN (nemzetközi neve):

zolpidem tartrate

Összetétel:

zolpidem tartrate 6.25 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

AMBIEN CR (zolpidem tartrate extended-release tablets) is 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)] . AMBIEN CR is contraindicated in patients - who have experienced complex sleep behaviors after taking AMBIEN CR [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 Clinical Considerations and Data] . Published data on the use

Termék összefoglaló:

AMBIEN CR 6.25 mg extended-release tablets are composed of two layers1 and are coated, pink, round, biconvex, debossed with A~ on one side and supplied as: AMBIEN CR 12.5 mg extended-release tablets are composed of two layers1 and are coated, blue, round, biconvex, debossed with A~ on one side and supplied as: Store between 15°C–25°C (59°F–77°F). Limited excursions permissible up to 30°C (86°F).

Engedélyezési státusz:

New Drug Application

Betegtájékoztató

AMBIEN CR- ZOLPIDEM TARTRATE TABLET, COATED
Sanofi-Aventis U.S. LLC
----------
MEDICATION GUIDE
AMBIEN CR® (ām'bē-ən see ahr)
(zolpidem tartrate) extended-release tablets C-IV
Read the Medication Guide that comes with AMBIEN CR 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
healthcare provider about your medical condition or treatment.
What is the most important information I should know about AMBIEN CR?
•
Do not take more AMBIEN CR than prescribed.
•
Do not take AMBIEN CR unless you are able to stay in bed a full night
(7 to 8 hours) before you
must be active again.
•
Take AMBIEN CR right before you get in bed, not sooner.
AMBIEN CR may cause serious side effects including complex sleep
behaviors that have caused serious
injury and death. After taking AMBIEN CR, you may get up out of bed
while not being fully awake and
do an activity that you do not know you are doing (complex sleep
behaviors). The next morning, you may
not remember that you did anything during the night. These activities
may occur with AMBIEN CR
whether or not you drink alcohol or take other medicines that make you
sleepy. Reported activities
include:
•
driving a car ("sleep-driving")
•
making and eating food
•
talking on the phone
•
having sex
•
sleep-walking
Stop taking AMBIEN CR and call your healthcare provider right away if
you find out that you have done
any of the above activities after taking AMBIEN CR.
You should not drive a car or do things that require clear thinking
the day after you take AMBIEN CR.
Do not take AMBIEN CR if you:
•
have ever experienced a complex sleep behavior (such as driving a car,
making and eating food,
talking on the phone, or having sex while not being fully awake) after
taking AMBIEN CR.
•
drank alcohol that evening or before bed.
•
take other medicines that can make you sleepy. Taking AMBIEN CR with
other drugs can cause
side effects. Talk to your healthcare provider about all

Termékjellemzők

AMBIEN CR- ZOLPIDEM TARTRATE TABLET, COATED
SANOFI-AVENTIS U.S. LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMBIEN CR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR AMBIEN CR.
AMBIEN CR (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 AMBIEN CR. SOME OF THESE
EVENTS MAY RESULT IN SERIOUS
INJURIES, INCLUDING DEATH. DISCONTINUE AMBIEN CR IMMEDIATELY IF A
PATIENT EXPERIENCES A COMPLEX SLEEP
BEHAVIOR. (4, 5.1)
INDICATIONS AND USAGE
AMBIEN CR, a gamma-aminobutyric acid (GABA) A receptor positive
modulator, is indicated for the 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)
Recommended initial dose is a single dose of 6.25 mg for women and a
single dose of 6.25 or 12.5 mg for men,
immediately before bedtime with at least 7–8 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 AMBIEN CR (2.3)
Tablets to be swallowed whole, not to be crushed, divided or chewed
(2.4)
The effect of AMBIEN CR may be slowed if taken with or immediately
after a meal (2.4)
DOSAGE FORMS AND STRENGTHS
Extended-Release Tablets: 6.25 mg and 12.5 mg. Tablets not scored. (3)
CONTRAINDICATIONS
Patients who have experienced complex sleep behaviors after taking
AMBIEN CR (4)
Known hypersensitivity to zolpidem (4)
WARNINGS AND PRECAUTIONS
CNS-Depressant Effects: Impaired alertness and motor coordination,