ZOLPIDEM TARTRATE tablet, coated

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Proficient Rx LP

INN (Међународно име):

ZOLPIDEM TARTRATE

Састав:

ZOLPIDEM TARTRATE 5 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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)]. Pregnancy Category C There are no adequate and well-controlled studies of zolpidem in pregnant women. Studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially when taken with other CNS-depressants

Резиме производа:

Zolpidem tartrate tablets, USP are available as follows: 5 mg, are white, round-shaped, biconvex, film coated tablets, with ZLP debossed on one side and 5 on the other side. NDC 63187-691-15, bottle of 15 tablets NDC 63187-691-30, bottle of 30 tablets NDC 63187-691-60, bottle of 60 tablets NDC 63187-691-90, bottle of 90 tablets 10 mg, are yellow, round-shaped, biconvex, film coated tablets, with ZLP debossed on one side and 10 on the other side. NDC 63187-690-15, bottle of 15 tablets NDC 63187-690-30, bottle of 30 tablets NDC 63187-690-60, bottle of 60 tablets NDC 63187-690-90, bottle of 90 tablets Store at controlled room temperature 20° to 25°C (68° to 77°F).

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, COATED
Proficient Rx LP
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Medication Guide
Zolpidem Tartrate Tablets, USP C-IV
(ZOL-pih-dem)
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 are zolpidem tartrate tablets?
Zolpidem tartrate tablets are a sedative-hypnotic (sleep) medicine.
Zolpidem tartrate tablets are 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.
Zolpidem tartrate tablets

Карактеристике производа

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, COATED
PROFICIENT RX LP
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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 C-IV
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Zolpidem tartrate tablets, USP are a gamma-aminobutyric acid (GABA) A
agonist, is 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
•
•
•
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DOSAGE FORMS AND STRENGTHS
5 mg and 10 mg tablets. Tablets not scored. (3)
CONTRAINDICATIONS
Known hypersensitivity to zolpidem (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
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ADVERSE REACTIONS
Most commonly observed adverse reactions were:
Short-term (< 10 nights): Drowsiness, dizziness, and diarrhea
Long-term (28 to 35 nights): Dizziness and drugged feelings (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT
1-800-525-8747 OR FDA AT 1-800-FDA-
1088, OR HTTP://WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
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•
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Warnings and Precautions, Severe Injuries (5.8) 10/2014
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 to
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)
CNS depressant effects: Impairs alertness and motor coordination.
Instruct patients on correct use. (5.1)