Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
ZOLPIDEM TARTRATE (UNII: WY6W63843K) (ZOLPIDEM - UNII:7K383OQI23)
Mylan Pharmaceuticals Inc.
ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE 5 mg
ORAL
PRESCRIPTION DRUG
Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets 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)] . 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 reported a clear association with zolpidem and major birth defects [see Data]. Oral administration of zolpidem to pre
Zolpidem Tartrate Tablets, USP are available containing 5 mg or 10 mg of zolpidem tartrate, USP. The 5 mg tablets are lavender, film-coated, round, unscored tablets debossed with M over Z1 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5305-01 bottles of 100 tablets NDC 0378-5305-05 bottles of 500 tablets The 10 mg tablets are lavender, film-coated, round, unscored tablets debossed with M over Z2 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5310-01 bottles of 100 tablets NDC 0378-5310-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
Abbreviated New Drug Application
ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED Mylan Pharmaceuticals Inc. ---------- MEDICATION GUIDE Zolpidem Tartrate Tablets, USP CIV (zole pi' dem tar' trate) 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 a 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). Zolpidem tartrate tablets are not recommended for use in children under the age of 18 years. Zolpidem t Aqra d-dokument sħiħ
ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED MYLAN PHARMACEUTICALS INC. ---------- 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, FOR ORAL USE INITIAL U.S. APPROVAL: 1992 RECENT MAJOR CHANGES Warnings and Precautions, CNS Depressant Effects and Next- Day Impairment (5.1) 02/2019 INDICATIONS AND USAGE Zolpidem tartrate tablets, a gamma-aminobutyric acid (GABA) A receptor positive modulator, are indicated for the short- term treatment of insomnia characterized by difficulties with sleep initiation. (1) DOSAGE AND ADMINISTRATION • • • • • DOSAGE FORMS AND STRENGTHS 5 mg and 10 mg tablets. Tablets not scored. (3) CONTRAINDICATIONS Known hypersensitivity to zolpidem (4) WARNINGS AND PRECAUTIONS • • • • • • • • 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 MYLAN AT 1-877-446-3679 (1-877-4-INFO-RX) OR FDA AT 1-800-FDA-1088, OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • • • • Use the lowest dose effective for the patient and must not exceed a total of 10 mg daily (2.1) Recommended initial dose is a single dose of 5 mg for women and a single dose of 5 or 10 mg for men, immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening (2.1) Geriatric patients and patients with mild to moderate 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 tablets (2.3) The effect of zolpidem tartrate tablets may be slowed if taken with or immediately after a meal (2.4) CNS-Depressant Effects: Impairs alertness and motor coordination. Instruct patients on correct use Aqra d-dokument sħiħ