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ZolpiMist™: a new formulation of zolpidem tartrate for the short-term treatment of insomnia in the US

ZolpiMist™ is an oral spray formulation of the hypnotic compound zolpidem that was approved by the US Food and Drug Administration in 2008 with an indication for the short-term treatment of insomnia characterized by difficulty with sleep initiation. It was developed by NovaDel Pharma, Inc. using the...

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Autor principal: Neubauer, David N
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3630936/
https://www.ncbi.nlm.nih.gov/pubmed/23616700
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author Neubauer, David N
author_facet Neubauer, David N
author_sort Neubauer, David N
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description ZolpiMist™ is an oral spray formulation of the hypnotic compound zolpidem that was approved by the US Food and Drug Administration in 2008 with an indication for the short-term treatment of insomnia characterized by difficulty with sleep initiation. It was developed by NovaDel Pharma, Inc. using their patented NovaMist™ spray technology. The recommended doses are 10 mg for adults and 5 mg for elderly and debilitated patients to be taken once daily immediately before bedtime. Each metered spray contains 5 mg of zolpidem. ZolpiMist was approved through the 505(b)(2) pathway, which allowed reference to pre-existing efficacy and safety data for the equivalent doses of zolpidem immediate-release tablets. Bioequivalence and pharmacokinetic characteristics were demonstrated in clinical studies with healthy adult and elderly subjects. ZolpiMist is being investigated for the possible indication of use during middle-of-the-night awakenings when the patient has at least 4 hours available to remain in bed.
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spelling pubmed-36309362013-04-24 ZolpiMist™: a new formulation of zolpidem tartrate for the short-term treatment of insomnia in the US Neubauer, David N Nat Sci Sleep Review ZolpiMist™ is an oral spray formulation of the hypnotic compound zolpidem that was approved by the US Food and Drug Administration in 2008 with an indication for the short-term treatment of insomnia characterized by difficulty with sleep initiation. It was developed by NovaDel Pharma, Inc. using their patented NovaMist™ spray technology. The recommended doses are 10 mg for adults and 5 mg for elderly and debilitated patients to be taken once daily immediately before bedtime. Each metered spray contains 5 mg of zolpidem. ZolpiMist was approved through the 505(b)(2) pathway, which allowed reference to pre-existing efficacy and safety data for the equivalent doses of zolpidem immediate-release tablets. Bioequivalence and pharmacokinetic characteristics were demonstrated in clinical studies with healthy adult and elderly subjects. ZolpiMist is being investigated for the possible indication of use during middle-of-the-night awakenings when the patient has at least 4 hours available to remain in bed. Dove Medical Press 2010-05-10 /pmc/articles/PMC3630936/ /pubmed/23616700 Text en © 2010 Neubauer, publisher and licensee Dove Medical Press Ltd This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.
spellingShingle Review
Neubauer, David N
ZolpiMist™: a new formulation of zolpidem tartrate for the short-term treatment of insomnia in the US
title ZolpiMist™: a new formulation of zolpidem tartrate for the short-term treatment of insomnia in the US
title_full ZolpiMist™: a new formulation of zolpidem tartrate for the short-term treatment of insomnia in the US
title_fullStr ZolpiMist™: a new formulation of zolpidem tartrate for the short-term treatment of insomnia in the US
title_full_unstemmed ZolpiMist™: a new formulation of zolpidem tartrate for the short-term treatment of insomnia in the US
title_short ZolpiMist™: a new formulation of zolpidem tartrate for the short-term treatment of insomnia in the US
title_sort zolpimist™: a new formulation of zolpidem tartrate for the short-term treatment of insomnia in the us
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3630936/
https://www.ncbi.nlm.nih.gov/pubmed/23616700
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