Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
ZOLPIDEM TARTRATE (UNII: WY6W63843K) (ZOLPIDEM - UNII:7K383OQI23)
American Health Packaging
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 to 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 tablets [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 t
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. Unit dose packages of 100 (10 x 10) NDC 68084-189-01 Store at controlled room temperature 20° to 25°C (68° to 77°F). FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Abbreviated New Drug Application
American Health Packaging ---------- Medication Guide 8218901/0123 Zolpidem Tartrate Tablets, USP C-IV for oral use (ZOL-pih-dem) What is the most important information I should know about zolpidem tartrate tablets? Zolpidem tartrate tablets may cause serious side effects, including: • Complex sleep behaviors. 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. These activities may happen with zolpidem tartrate tablets whether or not you drink alcohol or take other medicines that make you sleepy. Some of these complex sleep behaviors have caused serious injury and death. People taking zolpidem tartrate tablets have reported: • sleep-walking • sleep-driving • making and eating food • talking on the phone • having sex Stop taking zolpidem tartrate tablets and tell your healthcare provider right away if you find out that you have done any of the above activities after taking zolpidem tartrate tablets. What are zolpidem tartrate tablets? Zolpidem tartrate tablets are a prescription sleep medicine used for the short-term treatment of adults who have trouble falling asleep (insomnia). • It is not known if zolpidem tartrate tablets are safe and effective in children under the age of 18 years. Zolpidem tartrate tablets are not recommended for use in children under the age of 18 years. • Zolpidem tartrate tablets is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep zolpidem tartrate tablets in a safe place to protect it from theft. Never give your zolpidem tartrate tablets to anyone else because it may cause death or harm them. Selling or giving away this medicine is against the law. Do not take zolpidem tartrate tablets if you: • Have had complex sleep behaviors that happened after taking zolpidem tartrate tablets in the past. See “ What is the most important information I should know a Lesen Sie das vollständige Dokument
ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, COATED AMERICAN HEALTH PACKAGING ---------- 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, C-IV 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 TABLETS. SOME OF THESE EVENTS MAY RESULT IN SERIOUS INJURIES, INCLUDING DEATH. DISCONTINUE ZOLPIDEM TARTRATE TABLETS IMMEDIATELY IF A PATIENT EXPERIENCES A COMPLEX SLEEP BEHAVIOR ( 4, 5.1). RECENT MAJOR CHANGES Dosage and Administration ( 2.1) 2/2022 Warnings and Precautions ( 5.5) 2/2022 Warnings and Precautions ( 5.7) 2/2022 INDICATIONS AND USAGE Zolpidem tartrate tablets are, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. ( 1) DOSAGE AND ADMINISTRATION Use the lowest dose effective for the patient and must not exceed a total of 10 mg daily ( 2.1) Treatment should be as short as possible ( 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 to 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) DOSAGE FORMS AND STRENGTHS 5 mg and 10 mg tablets. Tablets not scored. ( 3) CONTRAINDICA Lesen Sie das vollständige Dokument