País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
ZOLPIDEM TARTRATE (UNII: WY6W63843K) (ZOLPIDEM - UNII:7K383OQI23)
APOTHECA, INC
ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE 10 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 ]. 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. Pregnancy Teratogenic effects: Pregnancy Category C There are no adequate and well-controlled studies of zolpidem tartrate tablets 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. Children born to mothers taking sedative-hypnotic drugs may be at risk for withdrawal symptoms during the postnatal period. Neonatal flaccidity has also
Zolpidem Tartrate Tablets are available as: 5 mg, pink, film-coated, capsule-shaped, unscored, debossed "6468" on one side and debossed "V" on the reverse side, available as follows: NDC: 12634-943-95 BOTTLE OF 5 NDC: 12634-943-71 BOTTLE OF 30 NDC: 12634-943-60 BOTTLE OF 60 NDC: 12634-943-91 BLISTER PACK OF 1 10 mg, white, film-coated, capsule-shaped, unscored, debossed "6469" on one side and debossed "V" on the reverse side, available as follows: NDC: 12634-944-95 BOTTLE OF 5 NDC: 12634-944-00 BOTTLE OF 10 NDC: 12634-944-82 BOTTLE OF 12 NDC: 12634-944-85 BOTTLE OF 15 NDC: 12634-944-80 BOTTLE OF 20 NDC: 12634-944-79 BOTTLE OF 25 NDC: 12634-944-71 BOTTLE OF 30 NDC: 12634-944-50 BOTTLE OF 50 NDC: 12634-944-01 BOTTLE OF 100 NDC: 12634-944-91 BLISTER PACK OF 1 NDC: 12634-944-64 BLISTER CARD PACK OF 4 NDC: 12634-944-65 BLISTER CARD PACK OF 5 NDC: 12634-944-59 BLISTER CARD PACKOF 30 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET APOTHECA, INC ---------- MEDICATION GUIDE CIV ZOLPIDEM TARTRATE TABLETS 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 is zolpidem tartrate tablets? Zolpidem tartrate tablets is a sedative-hypnotic (sleep) medicine. Zolpidem tartrate tablets is 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 is a federally controlled substance (C-IV) because it can be abused or Leer el documento completo
ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET APOTHECA, INC ---------- ZOLPIDEM TARTRATE, TABLETS CIV DESCRIPTION Zolpidem tartrate is a gamma-aminobutyric acid (GABA) A agonist of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure: Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet includes the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and titanium dioxide; the 5-mg tablet also contains FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, polyethylene glycol, polyvinyl alcohol, and talc; the 10-mg tablet also contains stearic acid and triacetin. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic agent with a chemical structure unrelated to benzodiazepines, barbiturates, or other drugs with known hypnotic properties. It interacts with a GABA-BZ receptor complex and shares some of the pharmacological properties of the benzodiazepines. In contrast to the benzodiazepines, which non-selectively bind to and activate all BZ receptor subtypes, zolpidem in vitro binds the BZ1 receptor preferentially with a high affinity ratio of the α1/α5 subunits. This selective binding of zolpidem on the BZ1 receptor is not absolute, but it may explain the relative absence of myorelaxant and anticonvulsant effects in animal studies as well as the preservation of deep sleep (stages 3 and 4) in human studies of zolpidem tartrate at hypnotic doses. PHARMACOKINETICS The pharmacokinetic profile of zolpidem tartrate tablets is characterized by rapid absorption from the gastrointestinal tract and a short elimination half-life (T½) in healthy subjects. In a sing Leer el documento completo