ZOLPIDEM TARTRATE tablet, film coated

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Blenheim Pharmacal, Inc.

INN (국제 이름):

ZOLPIDEM TARTRATE

구성:

ZOLPIDEM TARTRATE 10 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Zolpidem tartrate tablets, USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, USP have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see  Clinical Studies (14) ]. The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpidem tartrate tablets are contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.3)] . Teratogenic effects : Pregnancy Category C There are no adequate and well-controlled studies of zolpidem tartrate tablets in pregnant women. Studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respir

제품 요약:

Zolpidem Tartrate Tablets, USP are available as: 5 mg, pink, film-coated, capsule-shaped, unscored, debossed "6468" on one side and debossed "V" on the reverse side, available as follows: 10 mg, white, film-coated, capsule-shaped, unscored, debossed "6469" on one side and debossed "V" on the reverse side, available as follows: Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED
Blenheim Pharmacal, Inc.
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MEDICATION GUIDE
CIV
ZOLPIDEM TARTRATE (zolˈ pi dem tarˈ trate) TABLETS, USP
Read the Medication Guide that comes with zolpidem tartrate tablets
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 zolpidem
tartrate tablets?
•
Do not take more zolpidem tartrate tablets than prescribed.
•
Do not take zolpidem tartrate tablets unless you are able to
stay in bed a full night (7 to 8 hours) before you must be active
again.
•
Take zolpidem tartrate tablets right before you get in bed, not
sooner.
Zolpidem tartrate tablets may cause serious side effects, including:
•
After taking zolpidem tartrate 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 zolpidem
tartrate tablets. Reported
activities include:
•
driving a car ("sleep-driving")
•
making and eating food
•
talking on the phone
•
having sex
•
sleep-walking
Call your healthcare provider right away if you find out that you have
done any of the above activities
after taking zolpidem tartrate tablets.
Do not take zolpidem tartrate tablets if you:
•
drank alcohol that evening or before bed
•
took another medicine to help you sleep
What is zolpidem tartrate tablets?
Zolpidem tartrate tablets is a sedative-hypnotic (sleep) medicine.
Zolpidem tartrate tablets is used in adults for the short-term
treatment of a sleep problem called insomnia
(trouble falling asleep).
It is not known if zolpidem tartrate tablets are safe and effective in
children under the age of 18 years.
Zolp

제품 특성 요약

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED
BLENHEIM PHARMACAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLPIDEM TARTRATE TABLETS, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLPIDEM TARTRATE
TABLETS, USP
ZOLPIDEM TARTRATE TABLETS, USP, FOR ORAL USE
CIV
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Warnings and Precautions, Severe Injuries ( 5.8) 10/2014
INDICATIONS AND USAGE
Zolpidem tartrate tablets, USP, a gamma-aminobutyric acid (GABA) A
agonist, are indicated for the short-term treatment of
insomnia characterized by difficulties with sleep initiation. Zolpidem
tartrate tablets, USP have been shown to decrease
sleep latency for up to 35 days in controlled clinical studies. ( 1)
DOSAGE AND ADMINISTRATION
Use the lowest dose effective for the patient ( 2.1)
Recommended initial dose is 5 mg for women and 5 or 10 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 hepatic impairment: Recommended
dose is 5 mg for men and women ( 2.2)
Lower doses of CNS depressants may be necessary when taken
concomitantly with zolpidem tartrate tablets ( 2.3)
The effect of zolpidem tartrate tablets may be slowed if taken with or
immediately after a meal ( 2.4)
DOSAGE FORMS AND STRENGTHS
5 mg and 10 mg tablets. Tablets not scored. ( 3)
CONTRAINDICATIONS
Known hypersensitivity to zolpidem. ( 4)
WARNINGS AND PRECAUTIONS
CNS depressant effects: Impairs alertness and motor coordination.
Instruct patients on correct use. ( ) CNS depressant
effects: Impairs alertness and motor coordination. Instruct patients
on correct use. ( 5.1)
Need to evaluate for co-morbid diagnosis: Reevaluate if insomnia
persists after 7 to 10 days of use. ( ) Need to evaluate
for co-morbid diagnosis: Reevaluate if insomnia persists after 7 to 10
days of use. ( 5.2)
Severe anaphylactic/anaphylactoid reactions: Angioedema and
anaphylaxis have been r