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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 

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