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 Further, no dependence, rebound insomnia or evidence of abuse or withdrawal symptoms indicative of physical dependence upon treatment discontinuation was observed in clinical trials. While there were some adverse reactions recorded, most were mild to moderate in intensity these include headache and somnolence. 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. 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.Īt 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. In both trials, the participants were randomised to receive daridorexant or placebo once daily, for three months. In total, 1,854 patients with insomnia were involved in the studies. 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. 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 impact insomnia has on patients’ daily lives can be physically and mentally detrimental. 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. Lisa Artis, Deputy CEO, The Sleep Charity UK, said: “Sleep is a fundamental pillar of our overall health and wellbeing. Increased risk and severity of long-term diseases or conditions.Mental health disorders such as depression, anxiety or substance abuse.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. ![]() ![]() How does insomnia impact on health and wellbeing?Ĭhronic insomnia is one of the most prevalent sleep disorders in Europe, affecting between 6-12% of the adult population. With this marketing authorisation, daridorexant becomes the first dual orexin receptor antagonist (DORA) authorised in Great Britain for the treatment of insomnia. A new treatment has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for patients with insomnia.ĭaridorexant (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.
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