The National Institute for Health and Care Excellence (NICE) has recommended Idorsia UK’s QUVIVIQ (daridorexant) to treat chronic insomnia in adults.
A Final Draft Guidance (FDG) has been issued for QUVIVIQ for the treatment of these patients with symptoms lasting for three nights or more per week for at least three months, and whose daily functioning is significantly affected.
This recommendation applies when cognitive behavioural therapy for insomnia (CBTi) has been attempted without success or when it is unavailable or unsuitable.
Within three months of initiation, treatment should be evaluated and discontinued for people whose chronic insomnia has not responded adequately.
Once NICE’s final technology appraisal is released, daridorexant will become the first dual orexin receptor antagonist (DORA) to be prescribed through the NHS in England and Wales.
Idorsia UK general manager Robert Moore said: “We are delighted that NICE has acknowledged the clinical benefits and value that this new treatment can offer to the eligible patient population with chronic insomnia.
“The improvement of daytime functioning should be a priority for patients with chronic insomnia as the disorder has a significant impact on workplace productivity and overall wellbeing.”
In August last year, daridorexant secured marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) to treat adult patients with insomnia. It was approved under the European Commission Decision Reliance Procedure.
The approval was based on data from two pivotal Phase III trials, which assessed the safety and efficacy of daridorexant in insomnia disorder patients.
The studies have shown that at the recommended dose, daridorexant enhanced sleep onset, sleep maintenance, sTST and daytime sleepiness in these patients at months one and three against placebo.