Hetlioz Approved for Nighttime Sleep Disturbances in Smith-Magenis Syndrome
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.
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.
Idorsia announced positive topline results from a phase 3 study of daridorexant, an investigational dual orexin receptor antagonist, for the treatment of insomnia.
The FDA has issued new guidance regarding the use of computerized behavioral therapy and other digital health therapeutic devices for psychiatric disorders during the coronavirus disease 2019 (COVID-19) pandemic.
The FDA has approved Somryst™ (Pear Therapeutics), a prescription digital therapeutic (PDT) intended for the treatment of patients 22 years of age and older with chronic insomnia.