Idorsia Requests DEA Lift Controlled Substance Restrictions On Dual Orexin Receptor Antagonists For Insomnia

 
• By Sue Sutter
  
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Schedule IV classification for Idorsia’s Quviviq, along with Merck & Co’s Belsomra and Eisai’s Dayvigo, distorts the drug class’ benefit-risk profile relative to other insomnia treatments, which are prioritized for prescribing but carry higher risk of abuse and other adverse events, company says.

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Idorsia seeks controlled substance descheduling for a class of insomnia medicines. • Source: Shutterstock

Removing the controlled substance scheduling restrictions from the dual orexin receptor antagonist (DORA) class of chronic insomnia drugs would improve patient access to a less harmful class of products and mark an incremental step toward reducing safety issues in patients who combine opioids with sleep disorder treatments, a new citizen petition states.

Idorsia Pharmaceuticals Ltd, which markets the insomnia drug Quviviq (daridorexant), has petitioned the Drug Enforcement Administration to initiate a...

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