ZOLPIDEM TARTRATE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

APOTHECA, INC

INN (Nome Internazionale):

ZOLPIDEM TARTRATE

Composizione:

ZOLPIDEM TARTRATE 10 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 ]. 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. 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 pregnancy, especially when taken with other CNS-depressants. Children born to mothers taking sedative-hypnotic drugs may be at risk for withdrawal symptoms during the postnatal period. Neonatal flaccidity has also

Dettagli prodotto:

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: NDC: 12634-943-95 BOTTLE OF 5 NDC: 12634-943-71 BOTTLE OF 30 NDC: 12634-943-60 BOTTLE OF 60 NDC: 12634-943-91 BLISTER PACK OF 1 10 mg, white, film-coated, capsule-shaped, unscored, debossed "6469" on one side and debossed "V" on the reverse side, available as follows: NDC: 12634-944-95 BOTTLE OF 5 NDC: 12634-944-00 BOTTLE OF 10 NDC: 12634-944-82 BOTTLE OF 12 NDC: 12634-944-85 BOTTLE OF 15 NDC: 12634-944-80 BOTTLE OF 20 NDC: 12634-944-79 BOTTLE OF 25 NDC: 12634-944-71 BOTTLE OF 30 NDC: 12634-944-50 BOTTLE OF 50 NDC: 12634-944-01 BOTTLE OF 100 NDC: 12634-944-91 BLISTER PACK OF 1 NDC: 12634-944-64 BLISTER CARD PACK OF 4 NDC: 12634-944-65 BLISTER CARD PACK OF 5 NDC: 12634-944-59 BLISTER CARD PACKOF 30 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET
APOTHECA, INC
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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 controlled substance (C-IV)
because it
can be abused or

Scheda tecnica

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET
APOTHECA, INC
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ZOLPIDEM TARTRATE, TABLETS CIV
DESCRIPTION
Zolpidem tartrate is a gamma-aminobutyric acid (GABA) A agonist of the
imidazopyridine class and is
available in 5 mg and 10 mg strength tablets for oral administration.
Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a]
pyridine-3-acetamide L-(+)-tartrate
(2:1). It has the following structure:
Zolpidem tartrate is a white to off-white crystalline powder that is
sparingly soluble in water, alcohol,
and propylene glycol. It has a molecular weight of 764.88.
Each zolpidem tartrate tablet includes the following inactive
ingredients: hypromellose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose, sodium
starch glycolate, and titanium
dioxide; the 5-mg tablet also contains FD&C Blue #2 Aluminum Lake,
FD&C Red #40 Aluminum Lake,
polyethylene glycol, polyvinyl alcohol, and talc; the 10-mg tablet
also contains stearic acid and
triacetin.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic agent
with a chemical structure unrelated
to benzodiazepines, barbiturates, or other drugs with known hypnotic
properties. It interacts with a
GABA-BZ receptor complex and shares some of the pharmacological
properties of the
benzodiazepines. In contrast to the benzodiazepines, which
non-selectively bind to and activate all BZ
receptor subtypes, zolpidem in vitro binds the BZ1 receptor
preferentially with a high affinity ratio of
the α1/α5 subunits. This selective binding of zolpidem on the BZ1
receptor is not absolute, but it may
explain the relative absence of myorelaxant and anticonvulsant effects
in animal studies as well as the
preservation of deep sleep (stages 3 and 4) in human studies of
zolpidem tartrate at hypnotic doses.
PHARMACOKINETICS
The pharmacokinetic profile of zolpidem tartrate tablets is
characterized by rapid absorption from the
gastrointestinal tract and a short elimination half-life (T½) in
healthy subjects.
In a sing