FDA Grants Breakthrough Therapy Designation for Daridorexant in Pediatric Insomnia

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to daridorexant for the treatment of insomnia disorder in patients aged 10 to less than 18 years. This designation acknowledges the clinical evidence supporting daridorexant and the significant unmet medical need for FDA-approved pharmacological treatments in pediatric insomnia.