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

trupharma, llc - ramelteon (unii: 901as54i69) (ramelteon - unii:901as54i69) - ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. the clinical trials performed in support of efficacy were up to six months in duration. the final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see clinical studies (14)]. patients who develop angioedema after treatment with ramelteon tablets should not be rechallenged with the drug. patients should not take ramelteon tablets in conjunction with fluvoxamine [see drug interactions (7)]. risk summary available data from postmarketing reports with ramelteon tablets use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic ef

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

quality care products, llc - ramelteon (unii: 901as54i69) (ramelteon - unii:901as54i69) - ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. the clinical trials performed in support of efficacy were up to six months in duration. the final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see clinical studies (14)]. patients who develop angioedema after treatment with ramelteon tablets should not be rechallenged with the drug. patients should not take ramelteon tablets in conjunction with fluvoxamine [see drug interactions (7)]. risk summary available data from postmarketing reports with ramelteon tablets use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects, in rats

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

upsher-smith laboratories, llc - ramelteon (unii: 901as54i69) (ramelteon - unii:901as54i69) - ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. the clinical trials performed in support of efficacy were up to six months in duration. the final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six month studies (adults and elderly), and at the end of the six month study (adults and elderly) [see clinical studies (14)] . patients who develop angioedema after treatment with ramelteon tablets should not be rechallenged with the drug. patients should not take ramelteon tablets in conjunction with fluvoxamine [see drug interactions (7)] . risk summary available data from postmarketing reports with ramelteon use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects, in rats at

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

direct_rx - ramelteon (unii: 901as54i69) (ramelteon - unii:901as54i69) - ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. the clinical trials performed in support of efficacy were up to six months in duration. the final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see clinical studies (14)]. 8.1 pregnancy risk summary available data from postmarketing reports with ramelteon tablets use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects, in rats at doses much greater than 36 times the recommended human dose (rhd) of 8 mg/day based on body surface area (mg/m 2) (see data). the estimated background risk of major birth defects and miscarriage for

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

bryant ranch prepack - ramelteon (unii: 901as54i69) (ramelteon - unii:901as54i69) - ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. the clinical trials performed in support of efficacy were up to six months in duration. the final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see clinical studies (14)]. patients who develop angioedema after treatment with ramelteon tablets should not be rechallenged with the drug. patients should not take ramelteon tablets in conjunction with fluvoxamine [see drug interactions (7)]. risk summary available data from postmarketing reports with ramelteon tablets use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, ramelteon produced evidence of deve

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

advanced rx pharmacy of tennessee, llc - ramelteon (unii: 901as54i69) (ramelteon - unii:901as54i69) - ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. the clinical trials performed in support of efficacy were up to six months in duration. the final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see clinical studies (14)]. patients who develop angioedema after treatment with ramelteon tablets should not be rechallenged with the drug. patients should not take ramelteon tablets in conjunction with fluvoxamine [see drug interactions (7)]. 8.1 pregnancy risk summary available data from postmarketing reports with ramelteon tablets use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic ef

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

xiromed, llc - ramelteon (unii: 901as54i69) (ramelteon - unii:901as54i69) - ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. the clinical trials performed in support of efficacy were up to six months in duration. the final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see clinical studies (14)] . patients who develop angioedema after treatment with ramelteon tablets should not be rechallenged with the drug. patients should not take ramelteon tablets in conjunction with fluvoxamine [see drug interactions (7)] . risk summary available data from postmarketing reports with ramelteon tablets use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects, in ra

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

direct_rx - ramelteon (unii: 901as54i69) (ramelteon - unii:901as54i69) - ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. the clinical trials performed in support of efficacy were up to six months in duration. the final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six month studies (adults and elderly), and at the end of the six month study (adults and elderly) [see clinical studies (14)]. patients who develop angioedema after treatment with ramelteon tablets should not be rechallenged with the drug. patients should not take ramelteon tablets in conjunction with fluvoxamine [see drug interactions (7)]. 8.1 pregnancy risk summary available data from postmarketing reports with ramelteon use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects,

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

granules pharmaceuticals inc. - ramelteon (unii: 901as54i69) (ramelteon - unii:901as54i69) - ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. the clinical trials performed in support of efficacy were up to six months in duration. the final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [ see clinical studies (14) ]. patients who develop angioedema after treatment with ramelteon tablets should not be rechallenged with the drug. patients should not take ramelteon tablets in conjunction with fluvoxamine [see drug interactions (7) ]. risk summary available data from post marketing reported with ramelteon use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, ramelteon produced evidence of developmental toxicity, including terato

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

dr.reddys laboratories inc - ramelteon (unii: 901as54i69) (ramelteon - unii:901as54i69) - ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset.   the clinical trials performed in support of efficacy were up to six months in duration. the final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see clinical studies (14)] patients who develop angioedema after treatment with ramelteon tablets should not be rechallenged with the drug. patients should not take ramelteon tablets in conjunction with fluvoxamine [see drug interaction (7)] . risk summary available data from postmarketing reports with ramelteon use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects, in rats at