Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
ZOLPIDEM TARTRATE (UNII: WY6W63843K) (ZOLPIDEM - UNII:7K383OQI23)
Proficient Rx LP
ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE 5 mg
ORAL
PRESCRIPTION DRUG
Zolpidem tartrate tablets,USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, USP 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 to 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)]. 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
Zolpidem tartrate tablets, USP are available as follows: 5 mg, are white, round-shaped, biconvex, film coated tablets, with ZLP debossed on one side and 5 on the other side. NDC 63187-691-15, bottle of 15 tablets NDC 63187-691-30, bottle of 30 tablets NDC 63187-691-60, bottle of 60 tablets NDC 63187-691-90, bottle of 90 tablets 10 mg, are yellow, round-shaped, biconvex, film coated tablets, with ZLP debossed on one side and 10 on the other side. NDC 63187-690-15, bottle of 15 tablets NDC 63187-690-30, bottle of 30 tablets NDC 63187-690-60, bottle of 60 tablets NDC 63187-690-90, bottle of 90 tablets Store at controlled room temperature 20° to 25°C (68° to 77°F).
Abbreviated New Drug Application
ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, COATED Proficient Rx LP ---------- Medication Guide Zolpidem Tartrate Tablets, USP C-IV (ZOL-pih-dem) 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). It is not known if zolpidem tartrate tablets are safe and effective in children under the age of 18 years. Zolpidem tartrate tablets Прочитать полный документ
ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, COATED PROFICIENT RX LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ZOLPIDEM TARTRATE TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLPIDEM TARTRATE TABLETS, USP ZOLPIDEM TARTRATE TABLETS, USP, FOR ORAL USE C-IV INITIAL U.S. APPROVAL: 1992 RECENT MAJOR CHANGES INDICATIONS AND USAGE Zolpidem tartrate tablets, USP are a gamma-aminobutyric acid (GABA) A agonist, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets, USP have been shown to decrease sleep latency for up to 35 days in controlled clinical studies. (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 to 35 nights): Dizziness and drugged feelings (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT 1-800-525-8747 OR FDA AT 1-800-FDA- 1088, OR HTTP://WWW.FDA.GOV/MEDWATCH DRUG INTERACTIONS • • • • • Warnings and Precautions, Severe Injuries (5.8) 10/2014 Use the lowest dose effective for the patient (2.1) Recommended initial dose is 5 mg for women and 5 or 10 mg for men, immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening (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 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. (5.1) Прочитать полный документ