USA - engelsk - NLM (National Library of Medicine)

pd-rx pharmaceuticals, 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 ). they have 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 capsules are contraindicated in patients: - who have experienced complex sleep behaviors after taking zaleplon capsules (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 tol

USA - engelsk - NLM (National Library of Medicine)

lupin pharmaceuticals,inc. - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 1.75 mg - 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 : zolpidem tartrate sublingual tablet 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. zolpidem tartrate sublingual tablets are contraindicated in patients who have experienced complex sleep behaviors after taking zolpidem tartrate sublingual tablets [see warnings and precautions (5.1) ] zolpidem tartrate sublingual tablets are contraindicated in patients with known hypersensitivity to zolpidem. observed reactions with zolpidem include anaphylaxis and angioedema [see warnings and precautions (5.3)]. pregnancy category c there are no adequate and well-controlled studies of zolpidem in pregnant women. studies in children to assess the effects of prenatal ex

USA - engelsk - NLM (National Library of Medicine)

humana pharmacy, inc. - nicotine (unii: 6m3c89zy6r) (nicotine - unii:6m3c89zy6r) - nicotine 2 mg - stop smoking aid

USA - engelsk - NLM (National Library of Medicine)

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

USA - engelsk - NLM (National Library of Medicine)

actavis pharma, inc. - estazolam (unii: 36s3eqv54c) (estazolam - unii:36s3eqv54c) - estazolam 1 mg - estazolam tablets, usp are indicated for the short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. both outpatient studies and a sleep laboratory study have shown that estazolam administered at bedtime improved sleep induction and sleep maintenance (see clinical pharmacology ). because insomnia is often transient and intermittent, the prolonged administration of estazolam is generally neither necessary nor recommended. since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered. there is evidence to support the ability of estazolam to enhance the duration and quality of sleep for intervals up to 12 weeks (see clinical pharmacology ). estazolam is contraindicated with ketoconazole and itraconazole, since these medications significantly impair oxidative metabolism mediated by cyp3a (see warnin

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

arrotex pharmaceuticals pty ltd - zolpidem tartrate, quantity: 10 mg - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; sodium starch glycollate; hypromellose; magnesium stearate; titanium dioxide; macrogol 400 - short-term treatment of insomnia in adults.

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

arrow pharma pty ltd - zolpidem tartrate -

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

amneal pharma australia pty ltd - zolpidem tartrate -

Australia - engelsk - 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.

USA - engelsk - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, inc. - triazolam (unii: 1hm943223r) (triazolam - unii:1hm943223r) - triazolam 0.25 mg - triazolam tablets are indicated for the short-term treatment of insomnia (generally 7 to 10 days). use for more than 2 to 3 weeks requires complete reevaluation of the patient (see warnings). prescriptions for triazolam should be written for short-term use (7 to 10 days) and it should not be prescribed in quantities exceeding a 1-month supply. triazolam tablets are contraindicated in patients with known hypersensitivity to this drug or other benzodiazepines. benzodiazepines may cause fetal damage when administered during pregnancy. an increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. transplacental distribution has resulted in neonatal cns depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. triazolam tablets are contraindicated in pregnant women. if there is a likelihood of the patient becoming pregnant while recei