NICE set to recommend new drug to treat long-term insomnia

The U.K.’s National Institute for Health and Care Excellence (NICE) has draft guidance recommending daridorexant (QUVIVIQ) as a second-line treatment of long-term insomnia. If approved by NICE’s consultees, the guidance will be the first time it has given a specific recommendation of a pharmaceutical treatment for long-term insomnia. First-line treatments include advice on sleep hygiene and cognitive behavioural therapy for insomnia. Long-term insomnia is when symptoms last for three or more nights per week for at least three months, affecting daytime function. Daridorexant was approved by Health Canada in April 2023 for the management of adults with insomnia. It’s a dual orexin receptor antagonist (DORA) and acts by blocking the orexin 1 and orexin 2 receptors, which promote wakefulness. The recommended dose is 50 mg, taken orally 30 minutes before going to bed, according to a press release from the manufacturer Idorsia Pharmaceuticals. Results from two large phase three randomized clinical trials involving daridorexant were published in The Lancet Neurology in February 2022. Patients randomized to daridorexant fell asleep more quickly, slept longer and had a self-reported better sleep compared to those on placebo. Adverse events were similar between placebo and daridorexant treatment groups and the most common adverse event was headache. There was no evidence of dependency, nor withdrawal symptoms if patients stopped taking daridorexant. NICE’s guidelines were last revised in May 2022. At that time, there were no specific pharmacological recommendations according to the Pharmaceutical Journal. The appeal period for the new NICE guidance closes at the end of September, and the publication date for the new guidance is expected to be Oct. 18. Read: Deprescribing: Three main types of meds it may be worth helping your patients cut

NICE set to recommend new drug to treat long-term insomnia

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