ZOLPIDEM TARTRATE tablet, extended release

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Sandoz Inc

Designació comuna internacional (DCI):

ZOLPIDEM TARTRATE

Composición:

ZOLPIDEM TARTRATE 6.25 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Zolpidem tartrate extended-release tablets are indicated for the short-term 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 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 defects [see Data]. Oral administration of zolpidem to pregnant rats and rabbits did not indicate a risk for adverse effec

Resumen del producto:

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. 12.5 mg, light pink, round, biconvex film-coated tablets debossed with SZ on one side and 229 on the other side. The tablets are to be swallowed whole and should not be crushed, chewed, or divided. Storage Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant, child-resistant container.

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

Sandoz Inc
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MEDICATION GUIDE
Zolpidem Tartrate Extended-Release Tablets, USP C-IV
(ZOL-pih-dem)
What is the most important information I should know about zolpidem
tartrate
extended-release tablets?
Zolpidem tartrate extended-release tablets may cause serious side
effects,
including:
•
Complex sleep behaviors. 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. These activities may
happen with zolpidem tartrate extended-release tablets whether or not
you
drink alcohol or take other medicines that make you sleepy. Some of
these
complex sleep behaviors have caused serious injury and death. People
taking
zolpidem tartrate extended-release tablets have reported:
o
sleep-walking
o
sleep-driving
o
making and eating food
o
talking on the phone
o
having sex
•
Stop taking zolpidem tartrate extended-release tablets and tell 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.
What are zolpidem tartrate extended-release tablets?
Zolpidem tartrate extended-release tablets are a prescription sleep
medicine used
for the treatment of adults who have trouble falling asleep or staying
asleep
(insomnia).
•
It is not known if zolpidem tartrate extended-release tablets are safe
and
effective in children under the age of 18 years. Zolpidem tartrate
extended-
release tablets are not recommended for use in children under the age
of 18
years.
Zolpidem tartrate extended-release tablets is a federally controlled
substance (C-
IV) because it can be abused or lead to dependence. Keep zolpidem
tartrate
extended-release tablets in a safe place to protect it from theft.
Never give your
zolpidem tartrate extended-release tablets to anyone else because it
can cause death
or harm them. Selling or giving away this medicine is against the law

Fitxa tècnica

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE
SANDOZ 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
WARNING: COMPLEX SLEEP BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
COMPLEX SLEEP BEHAVIORS INCLUDING SLEEP-WALKING, SLEEP-DRIVING, AND
ENGAGING IN OTHER
ACTIVITIES WHILE NOT FULLY AWAKE MAY OCCUR FOLLOWING USE OF ZOLPIDEM
TARTRATE EXTENDED-
RELEASE TABLETS. SOME OF THESE EVENTS MAY RESULT IN SERIOUS INJURIES,
INCLUDING DEATH.
DISCONTINUE ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS IMMEDIATELY IF
A PATIENT
EXPERIENCES A COMPLEX SLEEP BEHAVIOR. _(_4, 5.1_)_
RECENT MAJOR CHANGES
Indications and Usage (1) 2/2022
Dosage and Administration (2.1) 2/2022
Warnings and Precautions (5.5) 2/2022
Warnings and Precautions (5.7) 2/2022
INDICATIONS AND USAGE
Zolpidem tartrate extended-release tablets, a gamma-aminobutyric acid
(GABA) A receptor positive
modulator, are indicated for the treatment of insomnia characterized
by difficulties with sleep onset and/or
sleep maintenance. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Extended-Release Tablets: 6.25 mg and 12.5 mg. Tablets not scored. (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
Use the lowest dose effective for the patient and must not exceed a
total of 12.5 mg daily (2.1)
Treatment should be as short as possible (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 CN