ZOLPIDEM TARTRATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Novel Laboratories, Inc.

INN (International Name):

ZOLPIDEM TARTRATE

Composition:

ZOLPIDEM TARTRATE 1.75 mg

Administration route:

SUBLINGUAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zolpidem Tartrate Sublingual Tablet is indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Limitations of Use : Zolpidem Tartrate Sublingual Tablet is not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking. Zolpidem Tartrate Sublingual Tablets are contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema [see Warnings and Precautions (5.3)]. Pregnancy Category C There are no adequate and well-controlled studies of zolpidem 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 CNS-depressants. Children born to mothers taking

Product summary:

Each Zolpidem Tartrate Sublingual Tablet is individually packaged in a blister inside a unit-dose pouch. Zolpidem Tartrate Sublingual Tablets 1.75 mg are white to off white, round, flat faced beveled edged debossed with "N2" on one side and plain on the other side and supplied as: NDC 40032-762-30: Carton of 30 unit-dose pouches Zolpidem Tartrate Sublingual Tablets 3.5 are white to off white, round, flat faced beveled edged debossed with "NP" on one side and plain on the other side and supplied as: NDC 40032-761-30: Carton of 30 unit-dose pouches Storage and Handling Store between 20°C to 25°C (68°F to 77°F), [see USP Controlled Room Temperature]. Protect from moisture. The patient should be instructed not to remove the blister from the unit-dose pouch until the patient is ready to consume the sublingual tablet inside. Do not use if blister seal is broken or missing.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET
Novel Laboratories, Inc.
----------
MEDICATION GUIDE
Zolpidem Tartrate (ZOL-pi-dem TAR-trate or zole-PI-dem TAR-trate)
Sublingual Tablet CIV
Phenylketonurics
Phenylalanine is a component of aspartame. Each 3.5 mg and 1.75 mg
Zolpidem Tartarate Sublingual
Tablets contains 4.48 mg and 2.24 mg of phenylalanine.
Read the 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 doctor about your medical condition or
treatment.
What is the most important information I should know about Zolpidem
Tartrate Sublingual Tablet?
Follow the Instructions for Use at the end of this Medication Guide
when you take Zolpidem Tartrate
Sublingual Tablet. If you do not follow the Instructions for Use, you
might be drowsy in the morning
without knowing it.
•
Only take one Tablet a night, if needed.
•
Only take Zolpidem Tartrate Sublingual Tablet if you have at least 4
hours of bedtime left.
Zolpidem Tartrate Sublingual Tablet may cause serious side effects,
including:
•
After taking Zolpidem Tartrate Sublingual Tablet, 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 drank
alcohol that day or take other medicines
that make you sleepy with Zolpidem Tartrate Sublingual Tablet.
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 Sublingual Tablet.
Important:
1.
Take Zolpidem Tartrate Sublingual Tablet exactly as prescribed
2.
Do not take Zolpidem Tartrate Sublingual Tablet if you:
•
drank alcohol that

Summary of Product characteristics

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET
NOVEL LABORATORIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLPIDEM TARTRATE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLPIDEM TARTRATE.
ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE) TABLET FOR SUBLINGUAL USE.
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Zolpidem Tartrate is a GABA agonist indicated for use as needed for
the treatment of insomnia when a middle-of-the-
night awakening is followed by difficulty returning to sleep (1)
Limitation of Use: Not indicated for the treatment of middle-of-the
night awakening when the patient has fewer than 4 hours
of bedtime remaining before the planned time of waking (1)
DOSAGE AND ADMINISTRATION
Take only if 4 hours of bedtime remain before the planned time of
waking (2.1, 5.1)
Zolpidem Tartrate Sublingual Tablets should be placed under the tongue
and allowed to disintegrate completely before
swallowing. The tablet should not be swallowed whole. (2.1)
The effect of Zolpidem Tartrate Sublingual Tablets may be slowed if
taken with or immediately after a meal (2.1)
Recommended dose is 1.75 mg for women and 3.5 mg for men, taken only
once per night if needed (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 1.75 mg
for men and women (2.3)
Geriatric patients and patients with hepatic impairment: Recommended
dose is 1.75 mg for men and women (2.4,2.5)
DOSAGE FORMS AND STRENGTHS
1.75 mg and 3.5 mg sublingual tablets (3)
CONTRAINDICATIONS
Known hypersensitivity to zolpidem (4)
WARNINGS AND PRECAUTIONS
CNS depressant effects: Impairs alertness and motor coordination.
Instruct patients on correct use (5.1)
Evaluate for co-morbid diagnoses: Re-evaluate if insomnia persists
after 7 to 10 days of use (5.2)
Severe anaphylactic/anaphylactoid reactions: Angioedema and
anaphylaxis have been reported. Do not re-chal