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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

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

h.j. harkins company, inc. - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 10 mg - zolpidem tartrate tablets, usp are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets, usp 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 justifies the potential risk to the fetus. administration of zolpidem to pregnant rats and rabbits resul

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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

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

direct_rx - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate tablets, usp are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets, usp 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)] . 8.1 pregnancy 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 data]. the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations fetal/neonatal adverse reactions zolpidem crosses the placenta and may produce respiratory depression and sedation in neonates. monitor neonates exposed to zolpidem during pregnancy and labor for signs of excess sedation, hypotonia, and respiratory depression and manage accordingly. data human data published data from observational studies, birth registries, and case reports on the use of zolpidem during pregnancy do not report a clear association with zolpidem and major birth defects. there are limited postmarketing reports of severe to moderate cases of respiratory depression that occurred after birth in neonates whose mothers had taken zolpidem during pregnancy. these cases required artificial ventilation or intratracheal intubation. the majority of neonates recovered within hours to a few weeks after birth once treated. zolpidem has been shown to cross the placenta. animal data oral administration of zolpidem to pregnant rats during the period of organogenesis at 4, 20, and 100 mg base/kg/day, which are approximately 5, 25, and 120 times the maximum recommended human dose (mrhd) of 10 mg/day (8 mg zolpidem base) based on mg/m2 body surface area, caused delayed fetal development (incomplete fetal skeletal ossification) at maternally toxic (ataxia) doses 25 and 120 times the mrhd based on mg/m2 body surface area. oral administration of zolpidem to pregnant rabbits during the period of organogenesis at 1, 4, and 16 mg base/kg/day, which are approximately 2.5, 10, and 40 times the mrhd of 10 mg/day (8 mg zolpidem base) based on mg/m2 body surface area caused embryo-fetal death and delayed fetal development (incomplete fetal skeletal ossification) at a maternally toxic (decreased body weight gain) dose 40 times the mrhd based on mg/m2 body surface area. oral administration of zolpidem to pregnant rats from day 15 of gestation through lactation at 4, 20, and 100 mg base/kg/day, which are approximately 5, 25, and 120 times the mrhd of 10 mg/day (8 mg zolpidem base) based on mg/m2 body surface area, delayed offspring growth and decreased survival at doses 25 and 120 times, respectively, the mrhd based on mg/m2 body surface area. 8.2 lactation risk summary limited data from published literature report the presence of zolpidem in human milk. there are reports of excess sedation in infants exposed to zolpidem through breastmilk [see clinical considerations]. there is no information on the effects of zolpidem on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for zolpidem and any potential adverse effects on the breastfed infant from zolpidem or from the underlying maternal condition. clinical considerations infants exposed to zolpidem through breastmilk should be monitored for excess sedation, hypotonia, and respiratory depression. a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk during treatment and for 23 hours (approximately 5 elimination half-lives) after zolpidem administration in order to minimize drug exposure to a breast fed infant. 8.4 pediatric use zolpidem is not recommended for use in children. safety and effectiveness of zolpidem in pediatric patients below the age of 18 years have not been established. in an 8-week study, in pediatric patients (aged 6 to 17 years) with insomnia associated with attention-deficit/hyperactivity disorder (adhd) an oral solution of zolpidem tartrate dosed at 0.25 mg/kg at bedtime did not decrease sleep latency compared to placebo. psychiatric and nervous system disorders comprised the most frequent (>5%) treatment emergent adverse reactions observed with zolpidem versus placebo and included dizziness (23.5% vs. 1.5%), headache (12.5% vs. 9.2%), and hallucinations were reported in 7% of the pediatric patients who received zolpidem; none of the pediatric patients who received placebo reported hallucinations [see warnings and precautions ( 5.4)] . ten patients on zolpidem (7.4%) discontinued treatment due to an adverse reaction. 8.5 geriatric use a total of 154 patients in u.s. controlled clinical trials and 897 patients in non-u.s. clinical trials who received zolpidem were ≥60 years of age. for a pool of u.s. patients receiving zolpidem at doses of ≤10 mg or placebo, there were three adverse reactions occurring at an incidence of at least 3% for zolpidem and for which the zolpidem incidence was at least twice the placebo incidence (i.e., they could be considered drug related). adverse event zolpidem placebo dizziness 3% 0% drowsiness 5% 2% diarrhea 3% 1% a total of 30/1,959 (1.5%) non-u.s. patients receiving zolpidem reported falls, including 28/30 (93%) who were ≥70 years of age. of these 28 patients, 23 (82%) were receiving zolpidem doses >10 mg. a total of 24/1,959 (1.2%) non-u.s. patients receiving zolpidem reported confusion, including 18/24 (75%) who were ≥70 years of age. of these 18 patients, 14 (78%) were receiving zolpidem doses >10 mg. the dose of zolpidem tartrate tablets in elderly patients is 5 mg to minimize adverse effects related to impaired motor and/or cognitive performance and unusual sensitivity to sedative/hypnotic drugs [see warnings and precautions ( 5.1) ]. 8.6 gender difference in pharmacokinetics women clear zolpidem tartrate from the body at a lower rate than men. c max and auc parameters of zolpidem were approximately 45% higher at the same dose in female subjects compared with male subjects. given the higher blood levels of zolpidem tartrate in women compared to men at a given dose, the recommended initial dose of zolpidem for adult women is 5 mg, and the recommended dose for adult men is 5 or 10 mg. in geriatric patients, clearance of zolpidem is similar in men and women. the recommended dose of zolpidem in geriatric patients is 5 mg regardless of gender. 8.7 hepatic impairment the recommended dose of zolpidem tartrate tablets in patients with mild to moderate hepatic impairment is 5 mg once daily immediately before bedtime. avoid zolpidem tartrate tablets use in patients with severe hepatic impairment as it may contribute to encephalopathy [see dosage and administration ( 2.2), warnings and precautions ( 5.7), clinical pharmacology ( 12.3)]. 9.1 controlled substance zolpidem tartrate is classified as a schedule iv controlled substance by federal regulation. 9.2 abuse abuse and addiction are separate and distinct from physical dependence and tolerance. abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug effects over time. tolerance may occur to both desired and undesired effects of drugs and may develop at different rates for different effects. addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. its characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. drug addiction is a treatable disease, using a multidisciplinary approach, but relapse is common. studies of abuse potential in former drug abusers found that the effects of single doses of zolpidem tartrate 40 mg were similar, but not identical, to diazepam 20 mg, while zolpidem tartrate 10 mg was difficult to distinguish from placebo. because persons with a history of addiction to, or abuse of, drugs or alcohol are at increased risk for misuse, abuse and addiction of zolpidem, they should be monitored carefully when receiving zolpidem or any other hypnotic. 9.3 dependence physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. sedative/hypnotics have produced withdrawal signs and symptoms following abrupt discontinuation. these reported symptoms range from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, and convulsions. the following adverse events, which are considered to meet the dsm-iii-r criteria for uncomplicated sedative/hypnotic withdrawal, were reported during u.s. clinical trials following placebo substitution occurring within 48 hours following last zolpidem treatment: fatigue, nausea, flushing, lightheadedness, uncontrolled crying, emesis, stomach cramps, panic attack, nervousness and abdominal discomfort. these reported adverse events occurred at an incidence of 1% or less. however, available data cannot provide a reliable estimate of the incidence, if any, of dependence during treatment at recommended doses. postmarketing reports of abuse, dependence and withdrawal have been received.

United States - English - 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

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

direct rx - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 10 mg - zolpidem tartrate tablets usp are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets usp 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 is contraindicated in patients with known hypersensitivity to zolpidem. observed reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)]. 8.1 pregnancy teratogenic effects pregnancy category c there are no adequate and well-controlled studies of zolpidem tartrate 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 pregnan

United States - English - 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

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

direct rx - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg - 9.1 controlled substance zolpidem tartrate is classified as a schedule iv controlled substance by federal regulation. 9.2 abuse abuse and addiction are separate and distinct from physical dependence and tolerance. abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug effects over time. tolerance may occur to both desired and undesired effects of drugs and may develop at different rates for different effects. addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. it is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. drug addiction is a treatable disease, using a multidisciplinary approach, but r

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

a-s medication solutions - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - 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) ]. 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

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

bryant ranch prepack - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - 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 - who have experienced complex sleep behaviors after taking zolpidem tartrate extended-release tablets [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 have been reported to experience symptoms of respiratory depression and sedation [see cli