The MHRA has granted marketing authorisation to Quvivic, a drug indicated for adults with insomnia, its manufacturer has said.

Quviviq, which contains daridorexant, is indicated for the treatment of adult patients who have had insomnia for at least three months with `’considerable impact” on daytime functioning.

The drug “decreases the wake drive, allowing sleep to occur without altering the proportion of sleep stages,” said manufacturer Idorsia UK.

The MHRA decision came after the recent publication of Phase 3 data from two studies indicating that daridorexant improved sleep onset, sleep maintenance and daytime sleepiness at months one and three when compared to placebo.

Most adverse reactions such as fatigue, dizziness or nausea were mild or moderate, said Idorsia, adding that no withdrawal symptoms indicative of physical dependence were observed.

Idorsia UK general manager Robert Moore said the MHRA approval was a “significant development in the management of insomnia”.

He added: “Now that we have secured authorisation, we are working with UK national health authorities to agree on reimbursement for daridorexant.

“We expect to start making daridorexant available from mid-2023.”