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

arrow pharma pty ltd - atomoxetine hydrochloride -

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

arrow pharma pty ltd - atomoxetine hydrochloride -

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

arrow pharma pty ltd - atomoxetine hydrochloride -

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

arrow pharma pty ltd - atomoxetine hydrochloride -

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

arrow pharma pty ltd - atomoxetine hydrochloride -

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

purdue pharma lp - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 1.75 mg - intermezzo® (zolpidem tartrate) sublingual tablet is indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. limitations of use : intermezzo is not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking. intermezzo is contraindicated in patients who have experienced complex sleep behaviors after taking intermezzo [see warnings and precautions (5.1)] . intermezzo is contraindicated in patients with known hypersensitivity to zolpidem. observed reactions with zolpidem include anaphylaxis and angioedema [see warnings and precautions (5.4)] . there are no adequate and well-controlled studies of zolpidem 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 o

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

west-ward pharmaceuticals corp. - 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). risk summary: 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 lowes

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

unichem pharmaceuticals (usa), inc. - zaleplon (unii: s62u433rmh) (zaleplon - unii:s62u433rmh) - zaleplon 5 mg - zaleplon capsules are indicated for the short-term treatment of insomnia. zaleplon capsules have been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see clinical trials under clinical pharmacology ). it has not been shown to increase total sleep time or decrease the number of awakenings. the clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. the final formal assessments of sleep latency were performed at the end of treatment. zaleplon is contraindicated in patients: - who have experienced complex sleep behaviors after taking zaleplon (see warnings ) - with hypersensitivity to zaleplon or any excipients in the formulation (see precautions ) zaleplon is classified as a schedule iv controlled substance by federal regulation. 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 ot

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

pd-rx pharmaceuticals, inc. - zaleplon (unii: s62u433rmh) (zaleplon - unii:s62u433rmh) - zaleplon 10 mg - zaleplon capsules are indicated for the short-term treatment of insomnia. zaleplon capsules have been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see clinical trials under clinical pharmacology ). it has not been shown to increase total sleep time or decrease the number of awakenings. the clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. the final formal assessments of sleep latency were performed at the end of treatment. zaleplon is contraindicated in patients: - who have experienced complex sleep behaviors after taking zaleplon (see warnings ) - with hypersensitivity to zaleplon or any excipients in the formulation (see precautions ) zaleplon is classified as a schedule iv controlled substance by federal regulation. abuse and addiction are separate and distinct from physical dependence and tolerance. abuse is characterized by misuse of the d

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

aidarex pharmaceuticals llc - zaleplon (unii: s62u433rmh) (zaleplon - unii:s62u433rmh) - zaleplon 5 mg - zaleplon is indicated for the short-term treatment of insomnia. zaleplon has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see clinical trials   under clinical pharmacology ). it has not been shown to increase total sleep time or decrease the number of awakenings. the clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. the final formal assessments of sleep latency were performed at the end of treatment. hypersensitivity to zaleplon or any excipients in the formulation (see also precautions). zaleplon is classified as a schedule iv controlled substance by federal regulation. 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. physical dependence is a state of adaption that is manifested by a specific withdrawal syndrome that can be produced by abrupt ces