País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
ZOLPIDEM TARTRATE (UNII: WY6W63843K) (ZOLPIDEM - UNII:7K383OQI23)
Par Pharmaceutical, Inc.
ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE 5 mg
SUBLINGUAL
PRESCRIPTION DRUG
Zolpidem tartrate sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation [see Clinical Studies (14)] . The clinical trials performed with zolpidem tartrate 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 is contraindicated in patients: - who have experienced complex sleep behaviors after taking zolpidem tartrate [see Warnings and Precautions (5.1)]. - with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.4)] . Risk Summary Neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation (see Clinical Considerations and Data) . Published data on the use of zolpidem during pregnancy have not identified a drug-associated risk of and major birth defects (see Data). Or
Zolpidem tartrate sublingual tablets are supplied as sublingual tablets in two dosage strengths: Tablets are not scored. Zolpidem tartrate sublingual tablets 5 mg are white, round tablets, flat-faced, bevel-edged with debossed “P1” on one side and plain on the other side and supplied as: NDC Number Size 49884-903-52 10 tablets in one blister card 49884-903-55 Carton of 30 tablets in 3 blister cards The blister packs consist of aluminum/aluminum Child Resistant Control (CRC) blisters. Zolpidem tartrate sublingual tablets 10 mg are white, round tablets, flat-faced, bevel-edged with debossed “P7” on one side and plain on the other side and supplied as: NDC Number Size 49884-904-52 10 tablets in one blister card 49884-904-55 Carton of 30 tablets in 3 blister cards The blister packs consist of aluminum/aluminum Child Resistant Control (CRC) blisters. 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]. Protect from light and moisture.
Abbreviated New Drug Application
Par Pharmaceutical, Inc. ---------- MEDICATION GUIDE Zolpidem tartrate sublingual tablets C-IV (Zole-PI-dem TAR-trate) Read this 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 healthcare provider about your medical condition or treatment. What is the most important information I should know about zolpidem tartrate sublingual tablets? • Do not take more zolpidem tartrate sublingual tablets than prescribed. • Do not take zolpidem tartrate sublingual 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 sublingual tablets right before you get in bed, not sooner. 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. Do not take zolpidem tartrate sublingual tabletsif you: • have ever experienced a complex sleep behavior (such as driving a car, making and eating food, talking on the phone, or having sex) while not being fully awake after taking zolpidem tartrate sublingual tablets • drank alcohol that eveni Llegiu el document complet
ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE 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 BOXED 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 Boxed 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) 12/2018 INDICATIONS AND USAGE Zolpidem tartrate sublingual tablets, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate has been shown to decrease sleep latency for up to 35 days in controlled clinical studies. (1) (1) DOSAGE AND ADMINISTRATION Use the lowest dose effective for the patient (2.1) Recommended dose is 5 mg for women and 5 or 10 mg for men, immediately before bedtime. (2.1) Geriatric patients and patients with hepatic impairment: Recommended dose is 5 mg for men and women. (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 5 mg for men and women. (2.3) The effect of zolpidem tartrate sublingual tablets may be slowed if taken with or immediately after a meal. (2.4) Zolpidem tartrate sublingual tablet Llegiu el document complet