ZOLPIDEM TARTRATE- zolpidem tartrate tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Aphena Pharma Solutions - Tennessee, LLC

INN (Nome Internazionale):

ZOLPIDEM TARTRATE

Composizione:

ZOLPIDEM TARTRATE 5 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Zolpidem tartrate tablets, USP 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)] . 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. Children born to mothe

Dettagli prodotto:

Zolpidem Tartrate Tablets, USP are available containing 5 mg or 10 mg of zolpidem tartrate, USP. The 5 mg tablets are lavender film-coated, round, unscored tablets debossed with M over Z1 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5305-01 bottles of 100 tablets NDC 0378-5305-05 bottles of 500 tablets The 10 mg tablets are lavender film-coated, round, unscored tablets debossed with M over Z2 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5310-01 bottles of 100 tablets NDC 0378-5310-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED
Aphena Pharma Solutions - Tennessee, LLC
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MEDICATION GUIDE
ZOLPIDEM TARTRATE TABLETS, USP
(zole pi' dem tar' trate)
5 mg and 10 mg
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:
o
driving a car ("sleep-driving")
o
making and eating food
o
talking on the phone
o
having sex
o
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 is safe and effective in children under
the age of 18 years.
Zol

Scheda tecnica

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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 USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Warnings and Precautions, Severe Injuries (5.8) 10/2014
INDICATIONS AND USAGE
Zolpidem, 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
•
•
•
•
•
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
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 MYLAN PHARMACEUTICALS
INC. AT 1-877-446-3679 (1-877-
4-INFO-RX) OR FDA AT 1-800-FDA-1088, OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
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•
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•
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Use the lowest dose effective for the patient. (2.1)
Recommended initial dose is 5 mg for women and 5 mg 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 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.