Shots:

• 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