Tags : Insomnia

Biotech Regulatory

Eisai’s Dayvigo (lemborexant) Receives the US FDA’s Approval to Treat

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, […]Read More


Eisai and Purdue Report Result of Lemborexant in P-III SUNRISE

Shots: The P-III SUNRISE 2 study involves assessing of Lemborexant (5mg,10mg) vs PBO in 949 patients with insomnia disorder, characterized by difficulty in falling asleep/staying asleep aged 18 to 88yrs. P-III SUNRISE 2 study results: reductions in sleep onset latency (sSOL) (-21.81, -28.21 vs -11.43 min); improvement in sSE (14.19%, 14.31% vs 9.64%); reduction in […]Read More