国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ZOLPIDEM TARTRATE (UNII: WY6W63843K) (ZOLPIDEM - UNII:7K383OQI23)
Par Pharmaceutical, Inc.
ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE 1.75 mg
SUBLINGUAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 阅读完整的文件
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 阅读完整的文件