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Eisai's Dayvigo (lemborexant) Receives the US FDA's Approval to Treat Insomnia in Adults

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Eisai's Dayvigo (lemborexant) Receives the US FDA's Approval to Treat Insomnia in Adults

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  • The approval is based on two P-III studies (study 1 & 2) assessing Dayvigo (5mg/10mg- once nightly) vs PBO in patients aged ≥18yrs. & in female patients aged ≥55yrs. and male aged≥65yrs. for 6mos. & 1mos. who met DSM-5 criteria for insomnia disorder respectively
  • The collaborative results indicated that Dayvigo demonstrated superiority sSOL- sSEF- sWASO- LPS- SEF and WASO- effect at the beginning of treatment were generally consistent with later timepoints
  • The FDA has recommended Dayvigo to be classified as a controlled substance while recommendation has been submitted to the US DEA. Dayvigo is expected to be commercially available within 90days following DEA scheduling

Ref: Eisai | Image: Twitter

Click here to­ read the full press release 

Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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