ESZOPICLONE tablet, film coated United States - English - NLM (National Library of Medicine)

eszopiclone tablet, film coated

nucarepharmaceuticals, inc. - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone 3 mg - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). eszopiclone tablets are contraindicated in patients with known hypersensitivity to eszopiclone. hypersensitivity reactions include anaphylaxis and angioedema [see warnings and precautions ( 5.3)] . pregnancy category c there are no adequate and well-controlled studies in pregnant women. eszopiclone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of eszopiclone to pregnant ra

ESZOPICLONE tablet, film coated United States - English - NLM (National Library of Medicine)

eszopiclone tablet, film coated

direct rx - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone 1 mg - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). eszopiclone is contraindicated in patients with known hypersensitivity to eszopiclone. hypersensitivity reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)]. 8.1 pregnancy pregnancy category c there are no adequate and well-controlled studies in pregnant women. eszopiclone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of eszopiclone to pregnant rats (62.5, 125, or 250 mg/kg/day) and

ESZOPICLONE tablet, film coated United States - English - NLM (National Library of Medicine)

eszopiclone tablet, film coated

proficient rx lp - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone 1 mg - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6 week study (adults only), at the end of both 2 week studies (elderly only) and at the end of the 6 month study (adults only). eszopiclone is contraindicated in patients with known hypersensitivity to eszopiclone. hypersensitivity reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . there are no adequate and well-controlled studies in pregnant women. eszopiclone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of eszopiclone to pregnant rats (62.5, 125, or 250 mg/kg/day) and rabbits (4, 8, or 16 mg/kg/day) thr

ESZOPICLONE tablet, film coated United States - English - NLM (National Library of Medicine)

eszopiclone tablet, film coated

aphena pharma solutions - tennessee, llc - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone 2 mg - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). eszopiclone tablets are contraindicated in patients with known hypersensitivity to eszopiclone. hypersensitivity reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . there are no adequate and well controlled studies in pregnant women. eszopiclone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of eszopiclone to pregnant rats (62.5, 125 or 250 mg/kg/day) and rabbits (4, 8 or 16 mg/kg/d

ESZOPICLONE tablet, film coated United States - English - NLM (National Library of Medicine)

eszopiclone tablet, film coated

aidarex pharmaceuticals llc - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone 2 mg - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6 week study (adults only), at the end of both 2 week studies (elderly only) and at the end of the 6 month study (adults only). eszopiclone is contraindicated in patients with known hypersensitivity to eszopiclone. hypersensitivity reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . there are no adequate and well-controlled studies in pregnant women. eszopiclone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of eszopiclone to pregnant rats (62.5, 125, or 250 mg/kg/day) and rabbits (4, 8, or 16 mg/kg/day) thr

ESZOPICLONE tablet, film coated United States - English - NLM (National Library of Medicine)

eszopiclone tablet, film coated

sun pharmaceutical industries, inc. - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone 1 mg - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). eszopiclone is contraindicated in patients with known hypersensitivity to eszopiclone. hypersensitivity reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . pregnancy category c there are no adequate and well-controlled studies in pregnant women. eszopiclone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of eszopiclone to pregnant rats (62.5, 125, or 250 mg/kg/day) and rabbi

ESZOPICLONE tablet, film coated United States - English - NLM (National Library of Medicine)

eszopiclone tablet, film coated

macleods pharmaceuticals limited - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone 1 mg - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). • eszopiclone tablets are contraindicated in patients who have experienced complex sleep behaviors after taking eszopiclone tablets [see warnings and precautions (5.1) ]. • eszopiclone tablets are contraindicated in patients with known hypersensitivity to eszopiclone. hypersensitivity reactions include anaphylaxis and angioedema [see warnings and precautions (5.3) ]. risk summary available pharmacovigilance data with eszopiclone use in pregnant women are insufficient to identify a dr

ESZOPICLONE tablet, film coated United States - English - NLM (National Library of Medicine)

eszopiclone tablet, film coated

orchidpharma inc - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone 1 mg - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6 week study (adults only), at the end of both 2 week studies (elderly only) and at the end of the 6 month study (adults only). - eszopiclone is contraindicated in patients who have experienced complex sleep behaviors after taking eszopiclone [see warnings and precautions (5.1) ]. - eszopiclone is contraindicated in patients with known hypersensitivity to eszopiclone. hypersensitivity reactions include anaphylaxis and angioedema [see warnings and precautions (5.3) ]. risk summary available pharmacovigilance data with eszopiclone use in pregnant women are insufficient to identify a drug-associated risk of major birth

ESZOPICLONE tablet, film coated United States - English - NLM (National Library of Medicine)

eszopiclone tablet, film coated

mylan pharmaceuticals inc. - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone 1 mg - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). available pharmacovigilance data with eszopiclone tablets use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies conducted in pregnant rats and rabbits throughout organogenesis, there was no evidence of teratogenicity. administration of eszopiclone to rats throughout pregnancy and lactation resulted in offspring toxicities at all doses tested; the lowest dose was app

ESZOPICLONE tablet, film coated United States - English - NLM (National Library of Medicine)

eszopiclone tablet, film coated

golden state medical supply, inc. - eszopiclone (unii: uzx80k71oe) (eszopiclone - unii:uzx80k71oe) - eszopiclone 1 mg - eszopiclone tablets are indicated for the treatment of insomnia. in controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. the clinical trials performed in support of efficacy were up to 6 months in duration. the final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). - eszopiclone tablets are contraindicated in patients who have experienced complex sleep behaviors after taking eszopiclone tablets [see warnings and precautions (5.1)] . - eszopiclone tablets are contraindicated in patients with known hypersensitivity to eszopiclone. hypersensitivity reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . available pharma