ZOLPIDEM TARTRATE tablet, film coated

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Roxane Laboratories, Inc

INN (Alþjóðlegt nafn):

ZOLPIDEM TARTRATE

Samsetning:

ZOLPIDEM TARTRATE 5 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Zolpidem Tartrate Tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets has 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 to5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpidem Tartrate Tabelts 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. Child

Vörulýsing:

Zolpidem Tartrate Tablets, 5 mg are round, biconvex, pink, film coated tablets debossed with product identification "54 371" on one side and plain on the other and supplied as: NDC 0054-0086-25 bottle of 100 NDC 0054-0086-20 carton of 100 unit dose NDC 0054-0086-29 bottle of 500 Zolpidem Tartrate Tablets, 10 mg are round, biconvex, white, film coated tablets debossed with product identification "54 553" on one side and plain on the other and supplied as: NDC 0054-0087-25 bottle of 100 NDC 0054-0087-20 carton of 100 unit dose NDC 0054-0087-29 bottle of 500 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED
Roxane Laboratories, Inc
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MEDICATION GUIDE
Zolpidem Tartrate Tablets C-IV
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?
•
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 Zolpidem Tartrate in a saf

Vara einkenni

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED
ROXANE LABORATORIES, INC
----------
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 ADMINISTRATION C-IV
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Zolpidem Tartrate Tablets, a gamma-aminobutyric acid (GABA) A agonist,
is indicated for the short-term treatment of
insomnia characterized by difficulties with sleep initiation. Ambien
has 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 tartrate. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
ADVERSE REACTIONS
Most commonly observed adverse reactions were:
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ROXANE LABORATORIES,
INC. AT 1-800-962-8364 OR FDA
AT 1-800-FDA-1088 OR www.fda.gov/medwatch.
DRUG INTERACTIONS
•
•
Dosage and Administration (2) 4/2013
Dosage and Administration, Dosage in Adults (2.1) 4/2013
Warnings and Precautions (5) 4/2013
Use the lowest does 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)
Need to evaluate for co-morbid diagnosis: Reevaluate if insomnia
persists