Estats Units - anglès - NLM (National Library of Medicine)

watson laboratories - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - tablet - 5 mg - 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 [seeclinical studies (14) ]. the clinical trials performed in support of efficacy were 4-5 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 tartrate or to any of the inactive ingredients in the formulation. teratogenic effects: pregnancy category c zolpidem tartrate was administered to pregnant sprague-dawley rats by oral gavage during the period of organogenesis at doses of 4, 20, or 100 mg based/kg/day. adverse maternal and embryo/fetal effects occurred at doses of 20 mg base/kg and higher, manifesting as dose-related lethargy and ataxia in pregnant rats while examination of fetal skull bones revealed a dose-r

Estats Units - anglès - NLM (National Library of Medicine)

synthon pharmaceuticals, inc. - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - tablet, film coated - 5 mg - 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 4-5 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 tartrate or to any of the inactive ingredients in the formulation. teratogenic effects: pregnancy category c zolpidem tartrate was administered to pregnant sprague-dawley rats by oral gavage during the period of organogenesis at doses of 4, 20, or 100 mg based/kg/day. adverse maternal and embryo/fetal effects occurred at doses of 20 mg base/kg and higher, manifesting as dose-related lethargy and ataxia in pregnant rats while examination of fetal skull bones revealed a dose

Estats Units - anglès - NLM (National Library of Medicine)

yung shin pharmaceutical industries, co., ltd. - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - tablet, film coated - 5 mg - 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 4-5 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 tartrate or to any of the inactive ingredients in the formulation. teratogenic effects: pregnancy category c zolpidem tartrate was administered to pregnant sprague-dawley rats by oral gavage during the period of organogenesis at doses of 4, 20, or 100 mg based/kg/day. adverse maternal and embryo/fetal effects occurred at doses of 20 mg base/kg and higher, manifesting as dose-related lethargy and ataxia in pregnant rats while examination of fetal skull bones revealed a doser

Estats Units - anglès - NLM (National Library of Medicine)

st marys medical park pharmacy - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 12.5 mg - zolpidem tartrate extended-release tablets 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 tartrate or to any of the inactive ingredients in the formulation. observed reactions include anaphylaxis and angioedema [see warnings and precautions (5.2) ] pregnancy category c there are no adequate and well-controlled studies of zolpidem tartrate extended-release tablets in pregnant women. zolpidem tartrate extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk

Estats Units - anglès - NLM (National Library of Medicine)

unit dose services - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - 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 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 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 whe

Estats Units - anglès - NLM (National Library of Medicine)

par pharmaceutical, inc. - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 1.75 mg - zolpidem tartrate sublingual tablets are indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. limitations of use: zolpidem tartrate sublingual tablets are not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking. zolpidem tartrate is contraindicated in patients who have experienced complex sleep behaviors after taking zolpidem tartrate [see warnings and precautions (5.1)]. zolpidem tartrate is contraindicated in patients with known hypersensitivity to zolpidem. observed reactions with zolpidem include anaphylaxis and angioedema [see warnings and precautions (5.4)]. 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 ha

Estats Units - anglès - NLM (National Library of Medicine)

wockhardt limited - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg - 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 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpidem tartrate tablet is contraindicated in patients with known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation. observed reactions include anaphylaxis and angioedema [see warnings and precautions (5.2)]. pregnancy category c there are no adequate and well-controlled studies zolpidem tartrate tablets in pregnant women. zolpidem tartrate tablets should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. administration of zolpidem to pregnant rats and rabbits resulted in adverse

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

lupin australia pty limited - zolpidem tartrate, quantity: 10 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type a; hypromellose; magnesium stearate; titanium dioxide; macrogol 400 - zolpidem tartrate is indicated for the short term treatment of insomnia in adults (see dosage and administration).

Austràlia - anglès - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - zolpidem tartrate, quantity: 10 mg - tablet, film coated - excipient ingredients: hypromellose; titanium dioxide; magnesium stearate; sodium starch glycollate; microcrystalline cellulose; lactose monohydrate; macrogol 400 - zolpidem sandoz is indicated for the short-term treatment of insomnia in adults.

Estats Units - anglès - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg - 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 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpidem tartrate is contraindicated in patients with known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation. observed reactions include anaphylaxis and angioedema [see warnings and precautions (5.2)]. there are no adequate and well-controlled studies in pregnant women. zolpidem tartrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. administration of zolpidem to pregnant rats and rabbits resulted in adverse effects on offspring development at doses greater than the zo