Country: United States
Language: English
Source: NLM (National Library of Medicine)
ZOLPIDEM TARTRATE (UNII: WY6W63843K) (ZOLPIDEM - UNII:7K383OQI23)
Lake Erie Medical DBA Quality Care Products LLC
ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE 12.5 mg
ORAL
PRESCRIPTION DRUG
Zolpidem tartrate extended-release tablets, USP are indicated for the 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) ]. Zolpidem tartrate extended-release tablets are contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see WARNINGS AND PRECAUTIONS (5.3)]. Teratogenic Effects Pregnancy Category C There are no adequate and well-controlled studies of zolpidem tartrate extended-release 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 zolpi
Zolpidem tartrate extended-release tablets, USP are available as follows: 6.25 mg, dark pink, round, biconvex film-coated tablets debossed with SZ on one side and 228 on the other side. 12.5 mg, light pink, round, biconvex film-coated tablets debossed with SZ on one side and 229 on the other side. 55700-251-30 The tablets are to be swallowed whole and should not be crushed, chewed, or divided. Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant, child-resistant container.
Abbreviated New Drug Application
ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE Lake Erie Medical DBA Quality Care Products LLC ---------- MEDICATION GUIDE Zolpidem Tartrate Extended-Release Tablets, USPC-IV (ZOL-pih-dem) Read the Medication Guide that comes with zolpidem tartrate extended-release 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 extended-release tablets? • Do not take more zolpidem tartrate extended-release tablets than prescribed. • Do not take zolpidem tartrate extended-release 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 extended-release tablets right before you get in bed, not sooner. Zolpidem tartrate extended-release tablets may cause serious side effects that you may not know are happening to you. These side effects include: • sleepiness during the day • not thinking clearly • act strangely, confused, or upset • "sleep-walking" or doing other activities when you are asleep like: ∘ eating ∘ talking ∘ having sex ∘ driving a car Call your healthcare provider right away if you find out that you have done any of the above activities after taking zolpidem tartrate extended-release tablets. You should not drive a car or do things that require clear thinking the day after you take zolpidem tartrate extended-release tablets. Do not take zolpidem tartrate extended-release tablets if you: • drank alcohol that evening or before bed • take other medicines that can make you sleepy. Taking zolpidem tartrate extended-release tablets with other drugs can cause side effects. Talk to your healthcare provider about all of your medicines. Your healthcare provider will tell you if you can take zolpidem tartrate extended-release tablets with your other medicines. • cannot Read the complete document
ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS, USP. ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS, USP, FOR ORAL USE C-IV INITIAL U.S. APPROVAL: 1992 RECENT MAJOR CHANGES INDICATIONS AND USAGE Zolpidem tartrate extended-release tablets, USP a gamma-aminobutyric acid (GABA) A agonist, is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. (1) DOSAGE AND ADMINISTRATION • • • • • • DOSAGE FORMS AND STRENGTHS Tablets: 6.25 mg and 12.5 mg extended-release tablets. Tablets not scored. (3) CONTRAINDICATIONS Known hypersensitivity to zolpidem (4) WARNINGS AND PRECAUTIONS • • • • • • • • ADVERSE REACTIONS Most commonly observed adverse reactions (> 10% in either elderly or adult patients) are: headache, next-day somnolence and dizziness (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 6.25 mg for women, and 6.25 or 12.5 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 6.25 mg for men and women (2.2) Lower doses of CNS depressants may be necessary when taken concomitantly with zolpidem tartrate extended- release tablets (2.3) Tablets to be swallowed whole, not to be crushed, divided or chewed (2.4) The effect of zolpidem tartrate extended-release tablets may be slowed if taken with or immediately after a meal (2. Read the complete document