Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
ZOLPIDEM TARTRATE (UNII: WY6W63843K) (ZOLPIDEM - UNII:7K383OQI23)
sanofi-aventis U.S. LLC
zolpidem tartrate
zolpidem tartrate 6.25 mg
ORAL
PRESCRIPTION DRUG
AMBIEN CR (zolpidem tartrate extended-release tablets) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see Clinical Studies (14)] . AMBIEN CR is contraindicated in patients - who have experienced complex sleep behaviors after taking AMBIEN CR [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
AMBIEN CR 6.25 mg extended-release tablets are composed of two layers1 and are coated, pink, round, biconvex, debossed with A~ on one side and supplied as: AMBIEN CR 12.5 mg extended-release tablets are composed of two layers1 and are coated, blue, round, biconvex, debossed with A~ on one side and supplied as: Store between 15°C–25°C (59°F–77°F). Limited excursions permissible up to 30°C (86°F).
New Drug Application
AMBIEN CR- ZOLPIDEM TARTRATE TABLET, COATED Sanofi-Aventis U.S. LLC ---------- MEDICATION GUIDE AMBIEN CR® (ām'bē-ən see ahr) (zolpidem tartrate) extended-release tablets C-IV Read the Medication Guide that comes with AMBIEN CR 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 AMBIEN CR? • Do not take more AMBIEN CR than prescribed. • Do not take AMBIEN CR unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again. • Take AMBIEN CR right before you get in bed, not sooner. AMBIEN CR may cause serious side effects including complex sleep behaviors that have caused serious injury and death. After taking AMBIEN CR, 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 AMBIEN CR 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 AMBIEN CR and call your healthcare provider right away if you find out that you have done any of the above activities after taking AMBIEN CR. You should not drive a car or do things that require clear thinking the day after you take AMBIEN CR. Do not take AMBIEN CR if 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 AMBIEN CR. • drank alcohol that evening or before bed. • take other medicines that can make you sleepy. Taking AMBIEN CR with other drugs can cause side effects. Talk to your healthcare provider about all Lees het volledige document
AMBIEN CR- ZOLPIDEM TARTRATE TABLET, COATED SANOFI-AVENTIS U.S. LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AMBIEN CR SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMBIEN CR. AMBIEN CR (ZOLPIDEM TARTRATE) EXTENDED-RELEASE 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 AMBIEN CR. SOME OF THESE EVENTS MAY RESULT IN SERIOUS INJURIES, INCLUDING DEATH. DISCONTINUE AMBIEN CR IMMEDIATELY IF A PATIENT EXPERIENCES A COMPLEX SLEEP BEHAVIOR. (4, 5.1) INDICATIONS AND USAGE AMBIEN CR, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. (1) DOSAGE AND ADMINISTRATION Use the lowest dose effective for the patient and must not exceed a total of 12.5 mg daily (2.1) Recommended initial dose is a single dose of 6.25 mg for women and a single dose of 6.25 or 12.5 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 6.25 mg for men and women (2.2) Lower doses of CNS depressants may be necessary when taken concomitantly with AMBIEN CR (2.3) Tablets to be swallowed whole, not to be crushed, divided or chewed (2.4) The effect of AMBIEN CR may be slowed if taken with or immediately after a meal (2.4) DOSAGE FORMS AND STRENGTHS Extended-Release Tablets: 6.25 mg and 12.5 mg. Tablets not scored. (3) CONTRAINDICATIONS Patients who have experienced complex sleep behaviors after taking AMBIEN CR (4) Known hypersensitivity to zolpidem (4) WARNINGS AND PRECAUTIONS CNS-Depressant Effects: Impaired alertness and motor coordination, Lees het volledige document