ZOLPIDEM TARTRATE tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

DIRECT RX

INN (nemzetközi neve):

ZOLPIDEM TARTRATE

Összetétel:

ZOLPIDEM TARTRATE 10 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Zolpidem tartrate tablets, USP are 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 [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)]. 8.1 Pregnancy 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 pregnan

Termék összefoglaló:

Zolpidem Tartrate Tablets, USP 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].

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED
DIRECT RX
----------
SPL MEDGUIDE SECTION
CIV
ZOLPIDEM TARTRATE (zolˈ pi dem tarˈ trate) TABLETS, USP
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 tartra

Termékjellemzők

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED
DIRECT RX
----------
ZOLPIDEM TARTRATE
INDICATIONS & USAGE SECTION
Zolpidem tartrate tablets, USP are 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 [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.
DOSAGE & ADMINISTRATION SECTION
2.1 Dosage in Adults
Use the lowest effective dose for the patient. The recommended initial
dose is 5 mg for women and
either 5 or 10 mg for men, taken only once per night immediately
before bedtime with at least 7-8 hours
remaining before the planned time of awakening. If the 5 mg dose is
not effective, the dose can be
increased to 10 mg. In some patients, the higher morning blood levels
following use of the 10 mg dose
increase the risk of next day impairment of driving and other
activities that require full alertness
[see Warnings and Precautions (5.1)]. The total dose of zolpidem
tartrate tablets should not exceed 10
mg once daily immediately before bedtime.
The recommended initial doses for women and men are different because
zolpidem clearance is lower
in women.
2.2 Special Populations
Elderly or debilitated patients may be especially sensitive to the
effects of zolpidem tartrate. Patients
with hepatic insufficiency do not clear the drug as rapidly as normal
subjects. The recommended dose
of zolpidem tartrate in both of these patient populations is 5 mg once
daily immediately before bedtime
[see Warnings and Precautions (5.1); Use in Specific Populations
(8.5)].
2.3 Use with CNS Depressants
Dosage adjustment may be necessary when zolpidem tartrate tablets are
combined with other CNS
depressant drugs because of the potentially additive effects [see
Warnings and Precautions (5.1)].
2.4 Administration
The ef