ZOLPIDEM TARTRATE EXTENDED-RELEASE- zolpidem tartrate tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Par Pharmaceutical, Inc.

INN (International Name):

ZOLPIDEM TARTRATE

Composition:

ZOLPIDEM TARTRATE 6.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 - who have experienced complex sleep behaviors after taking zolpidem tartrate extended-release tablets [see Warnings and Precautions (5.1) ] . - with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.4) ] . 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 Cli

Product summary:

Zolpidem Tartrate Extended-Release Tablets, USP, 6.25 mg are available as yellow round film coated tablets engraved with “A117” on one side and plain on the other side. They are supplied as follows: NDC Number Size 10370-117-10 bottle of 100 Zolpidem Tartrate Extended-Release Tablets, USP, 12.5 mg are available as white to off-white round film coated tablets engraved with “A116” on one side and plain on the other side. They are supplied as follows: NDC Number Size 10370-116-10 bottle of 100 Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP controlled room temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ZOLPIDEM TARTRATE EXTENDED-RELEASE- ZOLPIDEM TARTRATE TABLET, FILM
COATED, EXTENDED
RELEASE
Par Pharmaceutical, Inc.
----------
MEDICATION GUIDE
Zolpidem Tartrate (zole-PI-dem TAR-trate) Extended-Release Tablets,
USP CIV
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 including complex sleep behaviors
that have caused serious injury and death. 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
(complex sleep behaviors). The next morning, you may not remember that
you did anything during the night.
These activities may occur with zolpidem tartrate extended-release
tablets whether or not you drink alcohol
or take other medicines that make you sleepy. Reported activities
include:
•
driving a car (“sleep-driving”)
•
making and eating food
•
talking on the phone
•
having sex
•
sleep-walking
Stop taking zolpidem tartrate extended-release tablets and 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 t

Summary of Product characteristics

ZOLPIDEM TARTRATE EXTENDED-RELEASE- ZOLPIDEM TARTRATE TABLET, FILM
COATED, EXTENDED RELEASE
PAR PHARMACEUTICAL, INC.
----------
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, USP, FOR ORAL USE CIV
INITIAL U.S. APPROVAL: 1992
_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
Boxed Warning
08/2019
Contraindications (4)
08/2019
Warnings and Precautions, Complex Sleep Behaviors (5.1)
08/2019
Warnings and Precautions, CNS Depressant Effects and Next Day
Impairment (5.2)
02/2019
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
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