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Zolpidem sublingual - Paratek Pharmaceuticals

Drug Profile

Zolpidem sublingual - Paratek Pharmaceuticals

Alternative Names: Intermezzo; Zolpidem hemitartrate; Zolpidem lozenge; Zolpidem tartrate; Zolpidem tartrate lozenge; Zolpidem tartrate sublingual; Zolpidem tartrate sublingual tablet; Zolpidem tartrate sublingual tablet C-IV

Latest Information Update: 23 May 2019

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At a glance

  • Originator TransOral Pharmaceuticals
  • Developer Paratek Pharmaceuticals
  • 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

Highest Development Phases

  • Market Withdrawal Insomnia

Most Recent Events

  • 30 Apr 2019 The FDA recommends to update the label of zolpidem sublingual (Intermezzo®) for Insomnia to include Black Box warning regarding the complex sleep behaviors
  • 29 Apr 2016 Biomarkers information updated
  • 30 Oct 2014 Transcept Pharmaceuticals Inc merged into Paratek Pharmaceuticals and is now called Paratek Pharmaceuticals
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