ZOLPIDEM- zolpidem tartrate tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Hikma Pharmaceuticals USA Inc.

INN (International Nazwa):

ZOLPIDEM TARTRATE

Skład:

ZOLPIDEM TARTRATE 5 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpidem tartrate is contraindicated in patients with known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.2)]. There are no adequate and well-controlled studies in pregnant women. Zolpidem tartrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Administration of zolpidem to pregnant rats and rabbits resulted in adverse effects on offspring development at doses greater than the zo

Podsumowanie produktu:

Zolpidem tartrate 5 mg and 10 mg tablets are supplied in bottles of 100 and bottles of 500. Zolpidem tartrate tablets 5 mg are oval-shaped, brick red, film coated, 10 x 4.5 mm tablets, imprinted with W62 on one side. The 10 mg tablets are oval-shaped, white, film coated, 10 x 4.5 mm tablets, imprinted with W63 on one side. Tablets are not scored. Store at controlled room temperature 20°-25° C (68°-77°F).

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

ZOLPIDEM- ZOLPIDEM TARTRATE TABLET
Hikma Pharmaceuticals USA Inc.
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MEDICATION GUIDE
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 doctor about your medical condition or treatment.
What is the most important information I should know about Zolpidem
Tartrate Tablets?
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 doctor right away if you find out that you have done any of
the above activities after taking
Zolpidem Tartrate Tablets.
Important:
1. Take Zolpidem Tartrate Tablets exactly as prescribed
•
Do not take more Zolpidem Tartrate Tablets than prescribed.
•
Take Zolpidem Tartrate Tablets right before you get in bed, not
sooner.
2. Do not take Zolpidem Tartrate Tablets if you:
•
drink alcohol
•
take other medicines that can make you sleepy. Talk to your doctor
about all of your medicines. Your
doctor will tell you if you can take Zolpidem Tartrate Tablets with
your other medicines.
•
cannot get a full night"s sleep
What is Zolpidem Tartrate Tablets?
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. Symptoms of
insomnia include:
•
trouble falling asleep
Zolpidem Tartrate tablets are not for children.
Zolpidem
Tartrate is a
federally
controlled
substance (C-
IV) because it
can be abu

Charakterystyka produktu

ZOLPIDEM- ZOLPIDEM TARTRATE TABLET
HIKMA PHARMACEUTICALS USA INC.
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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
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Indications and Usage (1) 03/2007
WARNINGS AND PRECAUTIONS (5) 03/2007
Severe anaphylactic and anaphylactoid reactions (5.2) 03/2007
Abnormal thinking and behvaioral changes (5.3) 03/2007
Special populations (5.6) 03/2007
INDICATIONS AND USAGE
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. (1)
DOSAGE AND ADMINISTRATION
Adult dose: 10 mg immediately before bedtime (2.1)
Elderly/debilitated patients/hepatically impaired: 5 mg once daily
immediately before bedtime (2.2)
Downward dosage adjustment may be necessary when used with CNS
depressants (2.3)
Should not be 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 tartrate or to any of the inactive
ingredients in the formulation (4.1)
WARNINGS AND PRECAUTIONS
Need to evaluate for co-morbid diagnosis: Reevaluate if insomnia
persists after 7 to 10 days of use (5.1)
Severe anaphylactic/anaphylactoid reactions: Angioedema and
anaphylaxis have been reported. Do not rechallenge if
such reactions occur.(5.2)
Abnormal thinking, behavior changes and complex behaviors:May include
"sleep-driving" and hallucinations.
Immediately evaluate any new onset behavioral changes.(5.3)
Depression: Worsening of depression or, suicidal thinking may occur.
Prescribe the least amount feasible to avoid
intentional overdose (5.3, 5.6)
Withdrawal effects: Symptoms may occur with rapid dose reduction or
discontinu