ZOLPIDEM TARTRATE SUBLINGUAL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Par Pharmaceutical, Inc.

INN (International Name):

ZOLPIDEM TARTRATE

Composition:

ZOLPIDEM TARTRATE 1.75 mg

Administration route:

SUBLINGUAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zolpidem tartrate sublingual tablets are 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 tablets are 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 is contraindicated in patients who have experienced complex sleep behaviors after taking zolpidem tartrate [see Warnings and Precautions (5.1)]. Zolpidem tartrate is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema [see Warnings and Precautions (5.4)]. 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 ha

Product summary:

Each sublingual tablet is individually packaged in a unit-dose pouch.   Zolpidem tartrate sublingual tablets 1.75 mg are white, round tablets, flat-faced, bevel-edged with debossed “NT” on one side and “124” on the other side and supplied as: Zolpidem tartrate sublingual tablets 3.5 mg are white, round tablets, flat-faced, bevel-edged with debossed “P” & “350” on one side and plain on the other side and supplied as: Storage and Handling Store between 20° to 25°C (68° to 77°F). Excursions permitted between 15° and 30°C (59° and 86°F). Protect from moisture. The patient should be instructed not to remove the sublingual tablet from the unit-dose pouch until the patient is ready to consume it.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ZOLPIDEM TARTRATE SUBLINGUAL- ZOLPIDEM TARTRATE SUBLINGUAL TABLET
Par Pharmaceutical, Inc.
----------
MEDICATION GUIDE
Zolpidem Tartrate Sublingual Tablets CIV
(ZÒL-PÍ-DUM TAR-TRA-ATE)
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 tablets?
Follow the Instructions for Use at the end of this Medication Guide
when you take zolpidem tartrate
sublingual tablets. 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 tablets if you have at least 4
hours of bedtime left.
Zolpidem tartrate sublingual tablets may cause serious side effects,
including:
•
Complex sleep behaviors that have caused serious injury and death.
After taking zolpidem tartrate
sublingual 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 (complex sleep behaviors). The next
morning, you may not
remember that you did anything during the night.These activities may
occur with zolpidem tartrate
sublingual tablets whether or not you drink alcohol or take other
medicines that make you sleepy.
Reported activities include:
•
driving a car ("sleep-driving")
•
making and eating food
•
talking on the phone
•
having sex
•
sleep-walking
Stop taking zolpidem tartrate sublingual tablets and call your
healthcare provider right away if you find
out that you have done any of the above activities after taking
zolpidem tartrate sublingual tablets.
Important:
1.Take zolpidem tartrate sublingual tablets exactly as prescribed
2.Do not take zolpidem tartrate sublingual tablets if you:
•
have ever experienced a complex sleep behavior (such as

Summary of Product characteristics

ZOLPIDEM TARTRATE SUBLINGUAL- ZOLPIDEM TARTRATE SUBLINGUAL TABLET
PAR PHARMACEUTICAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLPIDEM TARTRATE SUBLINGUAL
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ZOLPIDEM TARTRATE SUBLINGUAL
TABLETS.
ZOLPIDEM TARTRATE SUBLINGUAL TABLETS, FOR ORAL USE CIV
INITIAL U.S. APPROVAL: 1992
WARNING: COMPLEX SLEEP BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOX 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. SOME OF
THESE EVENTS MAY RESULT IN SERIOUS
INJURIES, INCLUDING DEATH. DISCONTINUE ZOLPIDEM TARTRATE IMMEDIATELY
IF A PATIENT EXPERIENCES A COMPLEX
SLEEP BEHAVIOR (4, 5.1).
RECENT MAJOR CHANGES
Box Warning
08/2019
Contraindications (4)
08/2019
Warnings and Precautions, Complex Sleep Behaviors (5.1)
08/2019
Warnings and Precautions, CNS Depressant Effects and Next-Day
Impairment (5.2) 02/2019
INDICATIONS AND USAGE
Zolpidem tartrate sublingual tablets are 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) (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) (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 take