ZOLPIDEM TARTRATE tablet, film coated, extended release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Physicians Total Care, Inc.

INN (Nome Internazionale):

ZOLPIDEM TARTRATE

Composizione:

ZOLPIDEM TARTRATE 6.25 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 tartrate or to any of the inactive ingredients in the formulation.  Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.2)]. Pregnancy Category C There are no adequate and well-controlled studies of zolpidem tartrate extended-release tablets in pregnant women. Zolpidem tartrate extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to t

Dettagli prodotto:

Zolpidem tartrate extended-release tablets 6.25 mg, are composed of two portions* and are coated, white, round, bi-convex, debossed with A2 on one side and supplied as: Each tablet contains 6.25 mg of zolpidem tartrate. *Portions are covered by the coating and are indistinguishable. Store at 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, FILM COATED, EXTENDED
RELEASE
Physicians Total Care, Inc.
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17.4 MEDICATION GUIDE
MEDICATION GUIDE
ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS
Rx Only
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 doctor about your medical condition
or treatment.
What is the most important information I should know about Zolpidem
Tartrate Extended-Release
Tablets?
After taking zolpidem tartrate extended-release 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 extended-release 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 extended-release tablets.
Important:
1. Take zolpidem tartrate extended-release tablets exactly as
prescribed
•
Do not take more zolpidem tartrate extended-release tablets than
prescribed.
•
Take zolpidem tartrate extended-release tablets right before you get
in bed, not sooner.
2. Do not take zolpidem tartrate extended-release 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
extended-release tablets with your other
medicines.
•
cannot get a full night’s sleep
What are Zolpidem Tartrate Extended-Release Tablets?
Zolpidem tartrate extended-release tablets are a sedative-hypnotic
(sleep) medicine. Zolpidem ta

Scheda tecnica

ZOLPIDEM TARTRATE - ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED
RELEASE
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLPIDEM TARTRATE SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR ZOLPIDEM TARTRATE.
ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET, FILM COATED, EXTENDED
RELEASE FOR ORAL USE.
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Indications and Usage (1) 12/2007
Warnings and Precautions
Severe anaphylactic and anaphylactoid reactions (5.2) 03/2007
Abnormal thinking and behavioral changes (5.3) 03/2007
Special populations (5.6) 04/2007
INDICATIONS AND USAGE
Zolpidem tartrate extended-release tablets are indicated for the
treatment of insomnia characterized by difficulties with
sleep onset and/or sleep maintenance. (1)
DOSAGE AND ADMINISTRATION
Adult dose: 12.5 mg once daily immediately before bedtime (2.1)
Elderly/debilitated/hepatically impaired patients: 6.25 mg once daily
immediately before bedtime (2.2)
Tablets to be swallowed whole, not to be crushed, divided or chewed.
Should not be taken with or immediately after a meal
(2.4)
DOSAGE FORMS AND STRENGTHS
6.25 mg extended-release tablets. Tablets not scored (3)
CONTRAINDICATIONS
Known hypersensitivity to zolpidem tartrate or to any of the inactive
ingredients in the formulation (4)
WARNINGS AND PRECAUTIONS
Need to evaluate for co-morbid diagnoses: Revaluate 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, behavioral changes, 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