ZOLPIDEM TARTRATE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

RPK Pharmaceuticals, Inc.

INN (Kansainvälinen yleisnimi):

ZOLPIDEM TARTRATE

Koostumus:

ZOLPIDEM TARTRATE 5 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Zolpidem tartrate tablets, USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, USP have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [ see Clinical Studies (14)] . The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpidem tartrate tablets are contraindicated in patients  - who have experienced complex sleep behaviors after taking zolpidem tartrate 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

Tuoteyhteenveto:

Product: 53002-1292 NDC: 53002-1292-1 10 TABLET in a BOTTLE NDC: 53002-1292-2 20 TABLET in a BOTTLE NDC: 53002-1292-3 30 TABLET in a BOTTLE Product: 53002-5020 NDC: 53002-5020-1 10 TABLET in a BOTTLE NDC: 53002-5020-2 20 TABLET in a BOTTLE NDC: 53002-5020-3 30 TABLET in a BOTTLE NDC: 53002-5020-5 5 TABLET in a BOTTLE

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET
RPK Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Zolpidem Tartrate (zole-PI-dem TAR-trate) Tablets, USP C-IV
What is the most important information I should know about zolpidem
tartrate tablets?
Zolpidem tartrate tablets may cause serious side effects, including:
• complex sleep behaviors . After taking zolpidem tartrate 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
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 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 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
tablets.
What are zolpidem tartrate tablets?
Zolpidem tartrate tablets is a prescription sleep medicine used for
the short-term treatment of adults who
have trouble falling asleep (insomnia).
• It is not known if zolpidem tartrate tablets is safe and effective
in children under the age of 18 years.
Zolpidem tartrate tablets is not
recommended for use in children under the age of 18 years.
• Zolpidem tartrate tablets is a federally controlled substance
(C-IV) because it can be abused or lead to
dependence. Keep
zolpidem tartrate tablets in a safe place to protect it from theft.
Never give your zolpidem tartrate
tablets to anyone else because it may cause
death or harm them. Selling or giving away this medicine is against
the law.
Do not take zolpidem tartrate tablets if you:
• have had complex sleep behaviors that happened after taking
zolpidem tartrate tablets in the past. See
“What is the most important
information

Valmisteyhteenveto

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET
RPK PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLPIDEM TARTRATE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ZOLPIDEM TARTRATE
TABLETS.
ZOLPIDEM TARTRATE TABLETS, FOR ORAL USE C
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
TARTARE TABLETS.
SOME OF THESE EVENTS MAY RESULT IN SERIOUS INJURIES, INCLUDING DEATH.
DISCONTINUE
ZOLPIDEM TARTARE TABLETS IMMEDIATELY IF A PATIENT EXPERIENCES A
COMPLEX SLEEP
BEHAVIOR ( 4, 5.1).
RECENT MAJOR CHANGES
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 tablets, USP a gamma-amino butyric acid (GABA) A
receptor positive modulator, is
indicated for the short-term treatment of insomnia characterized by
difficulties with sleep initiation. (1)
DOSAGE AND ADMINISTRATION
Use the lowest dose effective for the patient and must not exceed a
total of 10 mg daily ( 2.1)
Treatment should be as short as possible ( 2.1)
Recommended initial dose is a single dose of 5 mg for women and a
single dose of 5 or 10 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 5 mg
for men and women ( 2.2)
Lower doses of CNS depressants may be necessary when taken
concomitantly with zolpidem tartrate
tablets ( 2.3)
The effect of zolpidem tartrate tablets may be slowed if taken with or
immediately after a meal ( 2.4)
DOSAGE FORMS AND STRENGTHS
5 mg and 10 mg tablets. Tablets not scored. (3)
CONTRAINDICATIONS
Patients who have experienced complex sleep behavior