Australia - English - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - zolpidem tartrate -

United States - English - NLM (National Library of Medicine)

physician therapeutics llc - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg - enter section text here enter section text here 1. indications and usage 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. 2. dosage and administration the dose of zolpidem tartrate tablets should be individualized. 2.1 dosage in adults the recommended dose for adults is 10 mg once daily immediately before bedtime. the total zolpidem tartrate dose should not exceed 10 mg per day. 2.2 special populations elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. the recommen

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - zolpidem tartrate, quantity: 10 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type a; silicon dioxide; succinic acid; magnesium stearate; titanium dioxide; hypromellose; macrogol 4000 - for the short-term treatment of insomnia in adults.

Canada - English - Health Canada

apotex inc - zolpidem tartrate - tablet (orally disintegrating) - 10mg - zolpidem tartrate 10mg - miscellaneous anxiolytics sedatives and hypnotics

Canada - English - Health Canada

apotex inc - zolpidem tartrate - tablet (orally disintegrating) - 5mg - zolpidem tartrate 5mg - miscellaneous anxiolytics sedatives and hypnotics

Canada - English - Health Canada

mint pharmaceuticals inc - zolpidem tartrate - tablet (orally disintegrating) - 5mg - zolpidem tartrate 5mg - miscellaneous anxiolytics sedatives and hypnotics

Canada - English - Health Canada

mint pharmaceuticals inc - zolpidem tartrate - tablet (orally disintegrating) - 10mg - zolpidem tartrate 10mg - miscellaneous anxiolytics sedatives and hypnotics

Canada - English - Health Canada

pro doc limitee - zolpidem tartrate - tablet (orally disintegrating) - 5mg - zolpidem tartrate 5mg

Canada - English - Health Canada

pro doc limitee - zolpidem tartrate - tablet (orally disintegrating) - 10mg - zolpidem tartrate 10mg

United States - English - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - 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. observed reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)]. pregnancy category c there are no adequate and well-controlled studies of zolpidem tartrate extended-release 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 a