ZOLPIDEM TARTRATE- zolpidem tartrate tablet, film coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Proficient Rx LP

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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: 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 respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially wh

Produkt oversigt:

Zolpidem Tartrate Tablets 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].

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED
Proficient Rx LP
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MEDICATION GUIDE
CIV
ZOLPIDEM TARTRATE TABLETS
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.
Zolpidem tartrate tablets is a federally con

Produktets egenskaber

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM 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 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 (2) 4/2013
Dosage and Administration, Dosage in Adults (2.1) 4/2013
Warnings and Precautions (5) 4/2013
INDICATIONS AND USAGE
Zolpidem tartrate tablets, a gamma-aminobutyric acid (GABA) are A
agonist, 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. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
5 mg and 10 mg tablets. Tablets not scored. (3)
CONTRAINDICATIONS
Known hypersensitivity to zolpidem (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT QUALITEST
PHARMACEUTICALS, LLC AT 1-800-444-4011 OR
FDA AT 1-800-FDA-1088, OR HTTP://WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
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)
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. (5.2)
Severe anaphylactic/anaphylactoid