ZOLPIDEM TARTRATE- zolpidem tartrate tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Unit Dose Services

INN (International Name):

ZOLPIDEM TARTRATE

Composition:

ZOLPIDEM TARTRATE 12.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zolpidem tartrate extended-release tablets 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 with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.3) ]. Pregnancy Category C There are no adequate and well-controlled studies of zolpidem tartrate extended-release in pregnant women. Studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used at the

Product summary:

Product: 50436-3031 NDC: 50436-3031-1 30 TABLET, EXTENDED RELEASE in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE
Unit Dose Services
----------
MEDICATION GUIDE
Zolpidem Tartrate Extended-Release Tablets, USPC-IV
(ZOL-pih-dem)
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 that you may not know are
happening to you. These side effects include:
•
sleepiness during the day
•
not thinking clearly
•
act strangely, confused, or upset
•
"sleep-walking" or doing other activities when you are asleep like:
∘
eating
∘
talking
∘
having sex
∘
driving a car
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 take zolpidem tartrate extended-release tablets if you:
•
drank alcohol that evening or before bed
•
take other medicines that can make you sleepy. Taking zolpidem
tartrate extended-release tablets
with other drugs can cause side effects. Talk to your healthcare
provider about all of your
medicines. Your healthcare provider will tell you if you can take
zolpidem tartrate extended-release
tablets with your other medicines.
•
cannot get a full night's sleep
Wha

Summary of Product characteristics

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE
UNIT DOSE SERVICES
----------
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
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Zolpidem tartrate extended-release tablets a gamma-aminobutyric acid
(GABA) A agonist, 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
Tablets: 6.25 mg and 12.5 mg extended-release tablets. Tablets not
scored. (3)
CONTRAINDICATIONS
Known hypersensitivity to zolpidem (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
•
ADVERSE REACTIONS
Most commonly observed adverse reactions (> 10% in either elderly or
adult patients) are: headache, next-day
Dosage and Administration, Dosage in Adults (2.1) 08/2016
Dosage and Administration, Special Populations (2.2) 12/2016
Warnings and Precautions, CNS Depressant Effects
and Next-Day Impairment (5.1) 08/2016
Warnings and Precautions, Precipitation of Hepatic
Encephalopathy (5.7) 12/2016
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 or chewed
(2.4)
The effect of zolpidem tartrate e