Free special edition 2023

MARKETING AUTHORISATIONS

NEW SUBSTANCE Daridorexant ( quviviq °) in insomnia Evaluation not designed to demonstrate a therapeutic advance

NOTHING NEW The clinical evaluation of darid orexant in patients with chronic insomniawas not designed to demon strate a potential advance compared

cive to sleep. Physical exercise during the day helps with sleep, but vigorous activity in the hours preceding bedtime should be avoided (1). Cognitive behavioural therapy is a first-line option in chron ic insomnia, but it is sometimes difficult to access (1). Some drugs for temporary use. When cognitive be havioural therapy is not accessible or is not sufficiently effective, drugs such as benzodiazepines are an option, but their use should be limited to as short a period as possible because of their adverse effects (1,3). The efficacy of benzodiazepines or related drugs diminishes after less than two weeks of daily use (1). These drugs mainly carry a risk of somnolence, som nambulism and sleep automatisms, impairment of memory and concentration, cognitive disorders, confusion, falls, de pendence and withdrawal symptoms (1,2). Daridorexant is an antagonist of the receptors for orexins A and B (hypocretins 1 and 2), neuropeptides involved in main tenance of the waking state (3). Blocking the action of orexins is aimed at reducing wakefulness (4). A complete lack of orexins is associated with narcolepsy, a rare condition characterised by excessive daytime sleepiness, sleep attacks, hallucinations, sleep paralysis when falling asleep or awakening, cataplexy, nightmares and often disturbed sleep (5). Daridorexant has been granted marketing authorisation in Europe for adults with chronic insomnia that has an impact on daily activities (6). It is the first representative of this pharmaco logical class to be authorised in the European Union (3). Two other orexin receptor antagonists are already authorised for insomnia in various countries including Canada, the United States and Japan: suvorexant since 2014 and lemborexant since 2019 (3). Does daridorexant improve patients’ perception of sleep quality in chronic insomnia, particularly compared with other sleep-inducing drugs? Does it reduce the impact of sleep dis turbances on daily activities? And what are its adverse effects? WHAT’S NEW? An orexin receptor antagonist

with already available sleep-inducing drugs. While its mechanism of action is indeed different, there is no evidence that it represents a tangible clinical advance for patients. Follow-up is still too short to fully determine its adverse effects. In practice, as of early 2023, daridorexant has not been evaluated thoroughly enough to risk exposing patients to this drug, outside the setting of a clinical trial. When considering a pharmacological approach, it would be more prudent to continue to use the hypnotic drugs already available, despite their limitations, because of their longer history of use.

QUVIVIQ° - daridorexant tablets • 25mg or 50mg of daridorexant per tablet Idorsia Pharmaceuticals ■ Hypnotic; antagonist of orexinAand B receptors

■ Indication : adultswith “insomniacharacterised by symptoms pres ent for at least 3 months and considerable impact on daytime func tioning” . [EU centralised procedure] ■ Dosage : 25 or 50 mg once per day, to be taken 30 minutes before bedtime. “The treatment duration should be as short as possible”.

COMPARE BEFORE DECIDING

Insomnia in adults, in brief Patients who complain of insomnia describe an impact on daily activities due to fatigue or lack of energy, impairment of concentration and memory, or mood disturbances such as irritability (1,2). When the sleep disturbance has been occurring at least three times per week for three months or more, insom nia is said to be “chronic” (3,4). A non-pharmacological approach first. One of the first steps in helping a patient with troublesome insomnia is to look for contributing factors or a medical cause (psychiatric or other conditions) (1,2). A range of measures aimed at restoring good quality sleep include: not catching up sleep during the day, even after a poor night’s sleep; avoiding the use of stimu lants; limiting alcohol consumption; opting for light meals before bedtime; and creating a bedroom environment that is condu

Excerpt from Prescrire Int July/August 2023 Full article (5 pages) available to subscribers at english.prescrire.org

Page 6 • Prescrire International Special Edition 2023