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MHRA approves new treatment for patients with insomnia

A new treatment has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for patients with insomnia.

A new treatment has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for patients with insomnia.

Daridorexant (Quviviq) can be used to treat adults who have had persistent insomnia symptoms for at least three months, when these symptoms are having a considerable impact on daytime functioning.

With this marketing authorisation, daridorexant becomes the first dual orexin receptor antagonist (DORA) authorised in Great Britain for the treatment of insomnia.

How does insomnia impact on health and wellbeing?

Chronic insomnia is one of the most prevalent sleep disorders in Europe, affecting between 6-12% of the adult population.

It is a condition which can negatively impact both physical and mental health, and people with insomnia report a lower quality of life compared with people who are sleeping well. Complications include:

  • Lower performance at work or school
  • Slowed reaction time
  • Mental health disorders such as depression, anxiety or substance abuse
  • Increased risk and severity of long-term diseases or conditions.

Lisa Artis, Deputy CEO, The Sleep Charity UK, said: “Sleep is a fundamental pillar of our overall health and wellbeing. For people living with insomnia, a lack of sleep can have a negative impact on many aspects of daily life and daytime functioning – from studies and employment to social activities and relationships, as well as reduced workplace productivity.

“The impact insomnia has on patients’ daily lives can be physically and mentally detrimental. We welcome more investment, resources and new treatment options that can help address the insomnia problem in the UK.”

Daridorexant improved sleep onset, sleep maintenance, total sleep time and daytime sleepiness

The MHRA’s decision comes following recently published trial data from two studies that evaluated the efficacy and safety of daridorexant in patients with insomnia disorder.

In total, 1,854 patients with insomnia were involved in the studies. In both trials, the participants were randomised to receive daridorexant or placebo once daily, for three months. Study one randomised 930 patients to receive daridorexant 50 mg, 25 mg or placebo, and study two randomised 924 subjects to receive daridorexant 25 mg, 10 mg or placebo.

At the end of the three-month treatment period, a total of 576 patients were treated with daridorexant for at least six months of cumulative treatment, including 331 patients treated for at least 12 months.

These studies demonstrated that at the recommended dose, daridorexant improved sleep onset, sleep maintenance, self-reported total sleep time, and daytime sleepiness in adults with insomnia disorder at months one and three compared to placebo.

While there were some adverse reactions recorded, most were mild to moderate in intensity; these include headache and somnolence. Further, no dependence, rebound insomnia or evidence of abuse or withdrawal symptoms indicative of physical dependence upon treatment discontinuation was observed in clinical trials.

The marketing authorisation was also supported by the long-term follow-up extension study, which together with the pivotal trials, provides clinical data for up to 12 months of continuous treatment

A new therapeutic option for adults with insomnia

Robert Moore, General Manager of Idorsia UK, said: “The MHRA authorisation of daridorexant, our first treatment authorised in the UK, marks a major milestone for Idorsia UK and is a significant development in the management of insomnia.

“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.

“Clinicians in the UK will then have a new therapeutic option for eligible adults with insomnia whose symptoms have been present for at least three months and whose insomnia has a considerable impact on daytime functioning.”

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