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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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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Dove Medical Press
2010
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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 |
collection | PubMed |
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. |
format | Online Article Text |
id | pubmed-3630936 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2010 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT neubauerdavidn zolpimistanewformulationofzolpidemtartratefortheshorttermtreatmentofinsomniaintheus |