ZOLPIDEM TARTRATE tablet, film coated, extended release

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Actavis Pharma, Inc.

INN (nume internaţional):

ZOLPIDEM TARTRATE

Compoziție:

ZOLPIDEM TARTRATE 6.25 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Zolpidem tartrate extended-release tablets 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)]. Risk Summary Neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation [see Clinical Considerations and Data] . Published data on the use of zolpidem during pregnancy have not reported a clear association with zolpidem and major birth de

Rezumat produs:

Zolpidem Tartrate Extended-Release Tablets USP, 6.25 mg are composed of two portions* and are white, round, biconvex, unscored, coated tablets debossed with A2 on one side and plain on the other side and supplied as: NDC Number Size 0228-3481-11 bottle of 100 Each tablet contains 6.25 mg of zolpidem tartrate, USP. Zolpidem Tartrate Extended-Release Tablets USP, 12.5 mg are composed of two portions* and are yellow, round, biconvex, unscored, coated tablets debossed with A1 on one side and plain on the other side and supplied as: NDC Number Size 0228-3482-11 bottle of 100 Each tablet contains 12.5 mg of zolpidem tartrate, USP. *Portions are covered by the coating and are indistinguishable. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant, child-resistant container as defined in the USP.

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED
RELEASE
Actavis Pharma, Inc.
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MEDICATION GUIDE
ZOLPIDEM TARTRATE (zol' pi dem tar' trate) EXTENDED-RELEASE TABLETS
C-IV
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 g

Caracteristicilor produsului

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED
RELEASE
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLPIDEM TARTRATE EXTENDED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR ZOLPIDEM TARTRATE
EXTENDED-RELEASE TABLETS.
ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS, FOR ORAL USE C-IV
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Warnings and Precautions, CNS Depressant Effects and
Next-Day Impairment (5.1)
02/2019
INDICATIONS AND USAGE
Zolpidem tartrate extended-release tablets, a gamma-aminobutyric acid
(GABA) A receptor positive modulator, is indicated
for the treatment of insomnia characterized by difficulties with sleep
onset and/or sleep maintenance. (1)
DOSAGE AND ADMINISTRATION
Use the lowest dose effective for the patient and must not exceed a
total of 12.5 mg daily (2.1)
Recommended initial dose is a single dose of 6.25 mg for women, and a
single dose of 6.25 or 12.5 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 mild to moderate hepatic
impairment: Recommended dose is 6.25 mg for men and
women (2.2)
Lower doses of CNS depressants may be necessary when taken
concomitantly with zolpidem tartrate extended-release
tablets (2.3)
Tablets to be swallowed whole, not to be crushed, divided or chewed
(2.4)
The effect of zolpidem tartrate extended-release tablets may be slowed
if taken with or immediately after a meal (2.4)
DOSAGE FORMS AND STRENGTHS
Extended-Release Tablets: 6.25 mg and 12.5 mg. Tablets not scored. (3)
CONTRAINDICATIONS
Known hypersensitivity to zolpidem. (4)
WARNINGS AND PRECAUTIONS
CNS-depressant effects: Impaired alertness and motor coordination,
including risk of morning impairment. Caution
patients against driving and other activities requiring complete
mental alertness the morning after use. (5.1)
Need to evaluate for comorbid diagnoses: Re-valua