ZOLPIDEM TARTRATE tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

INN (International Name):

ZOLPIDEM TARTRATE

Composition:

ZOLPIDEM TARTRATE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets 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 is 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 of pregnancy have been reported to experience symptoms of respiratory depression and sedation [see Clinical Considerations and Data]. Published data on t

Product summary:

Zolpidem tartrate tablets, USP are available as follows: 5 mg, are white, round-shaped, biconvex, film coated tablets, with ZLP debossed on one side and 5 on the other side. Unit dose packages of 100 (10 x 10) NDC 68084-189-01 Store at controlled room temperature 20° to 25°C (68° to 77°F). FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

American Health Packaging
----------
Medication Guide
8218901/0123
Zolpidem Tartrate Tablets, USP C-IV
for oral use
(ZOL-pih-dem)
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:
•
sleep-walking
•
sleep-driving
•
making and eating food
•
talking on the phone
•
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 are 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 are safe and effective in
children under the age of 18
years. Zolpidem tartrate tablets are 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 I should know a

Summary of Product characteristics

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, COATED
AMERICAN HEALTH PACKAGING
----------
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-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 TABLETS.
SOME OF THESE EVENTS MAY RESULT IN SERIOUS INJURIES, INCLUDING DEATH.
DISCONTINUE
ZOLPIDEM TARTRATE 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 are, a gamma-aminobutyric 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)
CONTRAINDICA