This week news of a new treatment for insomnia; The FDA comment on magnesium hypertension claims; Transmucosal buprenorphine linked to dental decay; Researchers assess changes in menstrual cycles in relation to COVID vaccines; And experts have their say on the best diets for 2022.
The FDA has accepted for review the NDA for daridorexant, an investigational dual orexin receptor, for the treatment of insomnia in adults.
The approval was based on data from a 9-week, double-blind, placebo-controlled, crossover study which assessed the effects of Hetlioz in patients with SMS.
While valerian is considered a popular herbal supplement for managing sleep disorders, study outcomes related to its effectiveness have been inconsistent.
Benzodiazepines are widely used to treat a variety of conditions including anxiety disorders, insomnia and seizures.
The applications are supported by positive results from a double-masked, 4-week, pivotal phase 2/3 clinical trial that compared the effects of tasimelteon to placebo in 25 patients with SMS.
Positive topline results were announced from the second pivotal phase 3 study evaluating daridorexant (Idorsia), an investigational dual orexin receptor antagonist, for the treatment of insomnia.
This slideshow shows drug information for Dayvigo. Click here for the complete Dayvigo monograph.
Dayvigo (lemborexant; Eisai) is now available for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adult patients.
