ZOLPIDEM TARTRATE tablet

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Par Pharmaceutical, Inc.

INN (International Name):

ZOLPIDEM TARTRATE

রচনা:

ZOLPIDEM TARTRATE 5 mg

প্রশাসন রুট:

SUBLINGUAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Zolpidem tartrate sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation [see Clinical Studies (14)] . The clinical trials performed with zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpidem tartrate is contraindicated in patients: - who have experienced complex sleep behaviors after taking zolpidem tartrate [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 Clinical Considerations and Data) . Published data on the use of zolpidem during pregnancy have not identified a drug-associated risk of and major birth defects (see Data). Or

পণ্য সারাংশ:

Zolpidem tartrate sublingual tablets are supplied as sublingual tablets in two dosage strengths: Tablets are not scored. Zolpidem tartrate sublingual tablets 5 mg are white, round tablets, flat-faced, bevel-edged with debossed “P1” on one side and plain on the other side and supplied as: NDC Number                Size 49884-903-52               10 tablets in one blister card 49884-903-55               Carton of 30 tablets in 3 blister cards The blister packs consist of aluminum/aluminum Child Resistant Control (CRC) blisters. Zolpidem tartrate sublingual tablets 10 mg are white, round tablets, flat-faced, bevel-edged with debossed “P7” on one side and plain on the other side and supplied as: NDC Number                Size 49884-904-52               10 tablets in one blister card 49884-904-55               Carton of 30 tablets in 3 blister cards The blister packs consist of aluminum/aluminum Child Resistant Control (CRC) blisters. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Protect from light and moisture.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

Par Pharmaceutical, Inc.
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MEDICATION GUIDE
Zolpidem tartrate sublingual tablets C-IV
(Zole-PI-dem TAR-trate)
Read this Medication Guide that comes with zolpidem tartrate
sublingual 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 sublingual tablets?
•
Do not take more zolpidem tartrate sublingual tablets than prescribed.
•
Do not take zolpidem tartrate sublingual 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 sublingual tablets right before you get in bed,
not sooner.
Zolpidem tartrate sublingual tablets may cause serious side effects,
including:
•
Complex sleep behaviors that have caused serious injury and death.
After taking zolpidem tartrate
sublingual 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 sublingual 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 sublingual 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 sublingual tablets.
Do not take zolpidem tartrate sublingual tabletsif you:
•
have ever experienced a complex sleep behavior (such as driving a car,
making and eating food,
talking on the phone, or having sex) while not being fully awake after
taking zolpidem tartrate
sublingual tablets
•
drank alcohol that eveni

পণ্য বৈশিষ্ট্য

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET
PAR PHARMACEUTICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLPIDEM TARTRATE SUBLINGUAL
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ZOLPIDEM TARTRATE SUBLINGUAL
TABLETS.
ZOLPIDEM TARTRATE SUBLINGUAL TABLETS, FOR ORAL USE, CIV
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. SOME OF
THESE EVENTS MAY RESULT IN SERIOUS
INJURIES, INCLUDING DEATH. DISCONTINUE ZOLPIDEM TARTRATE 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) 12/2018
INDICATIONS AND USAGE
Zolpidem tartrate sublingual tablets, a gamma-aminobutyric acid (GABA)
A receptor positive modulator, is indicated for the
short-term treatment of insomnia characterized by difficulties with
sleep initiation. Zolpidem tartrate has been shown to
decrease sleep latency for up to 35 days in controlled clinical
studies. (1) (1)
DOSAGE AND ADMINISTRATION
Use the lowest dose effective for the patient (2.1)
Recommended dose is 5 mg for women and 5 or 10 mg for men, immediately
before bedtime. (2.1)
Geriatric patients and patients with hepatic impairment: Recommended
dose is 5 mg for men and women. (2.2)
Lower doses of CNS depressants may be necessary when taken
concomitantly with zolpidem tartrate sublingual tablets.
(2.3)
Co-administration with CNS depressants: Recommended dose is 5 mg for
men and women. (2.3)
The effect of zolpidem tartrate sublingual tablets may be slowed if
taken with or immediately after a meal. (2.4)
Zolpidem tartrate sublingual tablet