ZOLPIDEM TARTRATE - zolpidem tartrate tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

A-S Medication Solutions

INN (Kansainvälinen yleisnimi):

ZOLPIDEM TARTRATE

Koostumus:

ZOLPIDEM TARTRATE 5 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets 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 There are no adequate and well-controlled studies of zolpidem tartrate 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-d

Tuoteyhteenveto:

Product: 50090-2649 NDC: 50090-2649-0 20 TABLET, FILM COATED in a BOTTLE NDC: 50090-2649-1 30 TABLET, FILM COATED in a BOTTLE NDC: 50090-2649-2 10 TABLET, FILM COATED in a BOTTLE NDC: 50090-2649-3 3 TABLET, FILM COATED in a BOTTLE

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

ZOLPIDEM TARTRATE - ZOLPIDEM TARTRATE TABLET, FILM COATED
A-S Medication Solutions
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MEDICATION GUIDE
Zolpidem Tartrate Tablets, USP C-IV
(zol' pi dem tar' trate)
Read the Medication Guide that comes with zolpidem tartrate 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?
•
Do not take more zolpidem tartrate than prescribed.
•
Do not take zolpidem tartrate unless you are able to stay in bed a
full night (7 to 8 hours) before
you must be active again.
•
Take zolpidem tartrate right before you get in bed, not sooner.
Zolpidem tartrate may cause serious side effects, including:
•
After taking zolpidem tartrate, 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. 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.
Do not take zolpidem tartrate if you:
•
drank alcohol that evening or before bed
•
took another medicine to help you sleep.
What is zolpidem tartrate?
Zolpidem tartrate is a sedative-hypnotic (sleep) medicine. Zolpidem
tartrate 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 is safe and effective in children
under the age of 18 years.
Zolpidem tartrate is a federally controlled substance (C-IV) because
it can be abused or lead to
dependence. Keep z

Valmisteyhteenveto

ZOLPIDEM TARTRATE - ZOLPIDEM TARTRATE TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLPIDEM TARTRATE TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLPIDEM
TARTRATE TABLETS.
ZOLPIDEM TARTRATE TABLETS, FOR ORAL USE, CIV
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Dosage and Administration, Dosage in Adults (2.1) 08/2016
Dosage and Administration, Special Populations (2.2) 12/2016
Warnings and Precautions, CNS Depressant Effects and Next-Day
Impairment (5.1) 08/2016
Warnings and Precautions, Precipitation of Hepatic Encephalopathy
(5.7) 12/2016
INDICATIONS AND USAGE
Zolpidem tartrate tablets, a gamma-aminobutyric acid (GABA) A agonist,
are indicated for the short-term treatment of
insomnia characterized by difficulties with sleep initiation. (1)
DOSAGE AND ADMINISTRATION
Use the lowest dose effective for the patient and must not exceed a
total of 10 mg daily (2.1)
Recommended initial dose is a single dose of 5 mg for women and a
single dose of 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 mild to moderate 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. (5.1)
Need to evaluate for co-morbid diagnoses: Reevaluate if insomnia
persists after 7 to 10 days of use. (5.2)
Severe anaphylactic/anaphylactoid reactions: Angioedema and
anaphylaxis have been reported. Do not rechallenge if
suc