ZOLPIDEM TARTRATE tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Proficient Rx LP

INN (Nama Antarabangsa):

ZOLPIDEM TARTRATE

Komposisi:

ZOLPIDEM TARTRATE 5 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpidem tartrate tablets are contraindicated in patients 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 tablets 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 end of pregnancy, especially when taken with other

Ringkasan produk:

Zolpidem tartrate 5 mg tablets, USP are red colored, capsule shaped tablets with the Torrent logo debossed on one side and '5 MG' debossed on the other side and supplied as: NDC Number                                                                               Size 63187-558-05                                                                              bottle of 5 63187-558-15                                                                              bottle of 15 63187-558-30                                                                              bottle of 30 63187-558-60                                                                              bottle of 60 63187-558-90                                                                              bottle of 90 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].

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

ZOLPIDEM TARTRATE- zolpidem tartrate tablet
Proficient Rx LP
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MEDICATION GUIDE
Zolpidem Tartrate (zole-PI-dem TAR-trate) Tablets, USP C-IV
Read the Medication Guide that comes with zolpidem tartrate 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 tablets?
• Do not take more zolpidem tartrate tablets than prescribed.
• Do not take zolpidem tartrate 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 tablets right before you get in bed, not
sooner.
Zolpidem tartrate tablets may cause serious side effects, including:
•
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. You have a higher chance for doing these
activities if you drink alcohol or
take other medicines that make you sleepy with zolpidem tartrate
tablets. Reported activities include:
○ driving a car ("sleep-driving")
○ making and eating food
○ talking on the phone
○ having sex
○ sleep-walking
Call your healthcare provider right away if you find out that you have
done any of the above activities after
taking zolpidem tartrate tablets.
Do not take zolpidem tartrate tablets if you:
•
drank alcohol that evening or before bed
•
took another medicine to help you sleep.
What are zolpidem tartrate tablets?
Zolpidem tartrate tablets are sedative-hypnotic (sleep) medicine.
Zolpidem tartrate tablets are used in adults
for the short-term treatment of a sleep problem called insomnia
(trouble falling asleep).
It is not known if zolpidem tartrate tablets are safe and effective in
children under the age of 18 years.
Zolpidem tartrate is a fe

Ciri produk

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET
PROFICIENT RX LP
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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 USP, FOR ORAL USE, C-IV
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Warnings and Precautions, Severe Injuries (5.8) 10/2014
INDICATIONS AND USAGE
Zolpidem tartrate tablets, USP are gamma-amino butyric acid (GABA) A
agonist, 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. (1)
DOSAGE AND ADMINISTRATION
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•
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DOSAGE FORMS AND STRENGTHS
5 mg and 10 mg tablets. Tablets not scored. (3)
CONTRAINDICATIONS
Known hypersensitivity to zolpidem (4) (4)
WARNINGS AND PRECAUTIONS
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•
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ADVERSE REACTIONS
Most commonly observed adverse reactions were:
Short-term (< 10 nights): Drowsiness, dizziness, and diarrhea
Long-term (28 - 35 nights): Dizziness and drugged feelings (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TORRENT PHARMA INC. AT
1-269-544-2299
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 4/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1. INDICATIONS AND USAGE
2. DOSAGE AND ADMINISTRATION
2.1 Dosage in Adults
2.2 Special Populations
2.3 Use with CNS Depressants
2.4 Administration
3. DOSAGE FORMS AND STRENGTHS
4. CONTRAINDICATIONS
5. WARNINGS AND PRECAUTIONS
5.1 CNS Depressant Effects and Next-Day Impairment
5.2 Need to Evaluate for Co-Morbid Diagnoses
5.3 Severe Anaphylactic and Anaphylactoid Reactions
5.4 Abnormal Thinking and Behavioral Changes
5.5 Use in Patients with Depression
5.6 Respiratory Depression
5.7 Withdrawal Effects
5.8