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Zolpidem oral spray - Amherst Pharmaceuticals

Drug Profile

Zolpidem oral spray - Amherst Pharmaceuticals

Alternative Names: Zolpidem tartrate oro-mucosal spray - Amherst; Zolpimist

Latest Information Update: 07 Oct 2019

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At a glance

  • Originator NovaDel Pharma
  • Developer Amherst Pharmaceuticals; Aytu BioScience; SUDA; Teva Pharmaceuticals USA
  • Class Acetamides; Hypnosedatives; Imidazoles; Pyridines; Sleep disorder therapies; Small molecules
  • Mechanism of Action GABA A receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Insomnia
  • No development reported Sleep maintenance insomnia

Most Recent Events

  • 02 Oct 2019 Aytu BioScience and Validus Pharmaceuticals agree to co-promote zolpidem oral spray in the US
  • 30 Apr 2019 The FDA recommends to update the label of Zolpidem oral spray (Zolpimist®) for Insomnia to include Black Box warning regarding the complex sleep behaviors
  • 24 Apr 2019 Preregistration for Insomnia in Australia (Transmucosal)
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