ZOLPIMIST- zolpidem tartrate spray, metered Estados Unidos - inglês - NLM (National Library of Medicine)

zolpimist- zolpidem tartrate spray, metered

magna pharmaceuticals, inc. - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg - zolpimist (zolpidem tartrate) oral spray (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate has 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. zolpimist (zolpidem tartrate) oral spray is 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 zolpimist (zolpidem tartrate) oral spray 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

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