Australia - englanti - 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.

Malta - englanti - Malta Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - zolpidem tartrate - film-coated tablet - zolpidem tartrate 5 mg - psycholeptics

Malta - englanti - Malta Medicines Authority

aurobindo pharma (malta) limited vault 14, level 2, valletta waterfront, floriana frn 1913, malta - zolpidem tartrate - film-coated tablet - zolpidem tartrate 10 mg - psycholeptics

Yhdysvallat - englanti - NLM (National Library of Medicine)

invagen pharmaceuticals inc., - 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 [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. (also see section 5.2 severe anaphylactic and anaphyalctoid reactions) 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

Yhdysvallat - englanti - NLM (National Library of Medicine)

bryant ranch prepack - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 6.25 mg - zolpidem tartrate extended-release tablets are 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)]. zolpidem tartrate extended-release tablets are contraindicated in patients - who have experienced complex sleep behaviors after taking zolpidem tartrate extended-release [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 ha

Yhdysvallat - englanti - NLM (National Library of Medicine)

bryant ranch prepack - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 12.5 mg - zolpidem tartrate extended-release tablets are 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)]. zolpidem tartrate extended-release tablets are contraindicated in patients 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 of zolpidem during pregnancy have not reported a clear association with zolpidem and major birth defects [see data]. oral administration of zolpidem to pregnant rats and rabbits did not indicate a risk for adverse effec

Yhdysvallat - englanti - NLM (National Library of Medicine)

proficient rx lp - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate tablets is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets has 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 is contraindicated in patients 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 of zolpidem during pregnancy have not reported a clear association with zolpidem and major birth defects [see data]. oral administration of zolpidem to pregnant rats and rabbits did not indicate a risk for adverse effects on fetal development at clinically relevant doses [see dat

Yhdysvallat - englanti - NLM (National Library of Medicine)

life line home care services, inc. - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 10 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. 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 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

Yhdysvallat - englanti - NLM (National Library of Medicine)

redpharm drug, inc. - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg

Yhdysvallat - englanti - NLM (National Library of Medicine)

mutual pharmaceutical company, 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-