ZOLPIDEM TARTRATE tablet, extended release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

DIRECT RX

INN (Nome Internazionale):

ZOLPIDEM TARTRATE

Composizione:

ZOLPIDEM TARTRATE 12.5 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Zolpidem tartrate extended-release tablets, USP are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration[see CLINICAL STUDIES (14)]. - Zolpidem tartrate extended-release tablets are contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see WARNINGS AND PRECAUTIONS (5.3)]. Zolpidem tartrate extended-release 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 Pregnancy Category C There are no adequate and well-controlled studies of zolpidem tartrate extended-release in

Dettagli prodotto:

Zolpidem tartrate extended-release tablets, USP are available as follows: 6.25 mg, dark pink, round, biconvex film-coated tablets debossed with SZ on one side and 228 on the other side. NDC 0781-5315-31, bottles of 30 tablets NDC 0781-5315-01, bottles of 100 tablets NDC 0781-5315-05, bottles of 500 tablets 12.5 mg, light pink, round, biconvex film-coated tablets debossed with SZ on one side and 229 on the other side. NDC 0781-5316-31, bottles of 30 tablets NDC 0781-5316-01, bottles of 100 tablets NDC 0781-5316-05, bottles of 500 tablets The tablets are to be swallowed whole and should not be crushed, chewed, or divided. Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant, child-resistant container.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE
DIRECT RX
----------
SPL MEDGUIDE SECTION
•
MEDICATION GUIDE
Zolpidem Tartrate Extended-Release Tablets, USPC-IV
(ZOL-pih-dem)
Read the Medication Guide that comes with zolpidem tartrate
extended-release 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 extended-release
tablets?
•Do not take more zolpidem tartrate extended-release tablets than
prescribed.•Do not take
zolpidem tartrate extended-release 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
extended-release tablets right
before you get in bed, not sooner.
Zolpidem tartrate extended-release tablets may cause serious side
effects that you may not know
are happening to you. These side effects include:
•sleepiness during the day•not thinking clearly•act strangely,
confused, or upset•"sleep-walking"
or doing other activities when you are asleep like:
eating talking having sex driving a car
∘
∘
∘
∘
Call your healthcare provider right away if you find out that you have
done any of the above
activities after taking zolpidem tartrate extended-release tablets.
You should not drive a car or do things that require clear thinking
the day after you take zolpidem
tartrate extended-release tablets.
Do not take zolpidem tartrate extended-release tablets if you:
•drank alcohol that evening or before bed•take other medicines
that can make you sleepy. Taking
zolpidem tartrate extended-release tablets with other drugs can cause
side effects. Talk to your
healthcare provider about all of your medicines. Your healthcare
provider will tell you if you can
take zolpidem tartrate extended-release tablets with your other
medicines.•cannot get a full night's
sleep
What

Scheda tecnica

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE
DIRECT RX
----------
ZOLPIDEM TARTRATE
INDICATIONS & USAGE SECTION
Zolpidem tartrate extended-release tablets, USP are indicated for the
treatment of insomnia
characterized by difficulties with sleep onset and/or sleep
maintenance (as measured by wake time after
sleep onset).
The clinical trials performed in support of efficacy were up to 3
weeks (using polysomnography
measurement up to 2 weeks in both adult and elderly patients) and 24
weeks (using patient-reported
assessment in adult patients only) in duration[see CLINICAL STUDIES
(14)].
DOSAGE & ADMINISTRATION SECTION
2.1 Dosage in Adults
Use the lowest effective dose for the patient. The recommended initial
dose is 6.25 mg for women
and either 6.25 or 12.5 mg for men, taken only once per night
immediately before bedtime with at
least 7 to 8 hours remaining before the planned time of awakening. If
the 6.25 mg dose is not
effective, the dose can be increased to 12.5 mg. In some patients, the
higher morning blood levels
following use of the 12.5 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 extended-release tablets should not exceed 12.5
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 extended-release tablets in both
of these patient populations
is 6.25 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
extended-release tablets are combined
with other CNS depressant drugs