Lemborexant in insomnia disorder: a profile of its use
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ADIS DRUG Q&A
Lemborexant in insomnia disorder: a profile of its use Hannah A. Blair1 Published online: 5 September 2020 © Springer Nature Switzerland AG 2020
Abstract Lemborexant (Dayvigo™), a dual orexin receptor antagonist, is an effective and well-tolerated treatment option for adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. In phase 3 clinical trials, oral lemborexant 5 or 10 mg once nightly significantly reduced sleep onset latency (SOL) and wake-after-sleep onset (WASO), and improved sleep efficiency (SE). Lemborexant was also associated with reductions in patient-reported fatigue and insomnia severity, and was well tolerated through 12 months of treatment. In special safety studies, lemborexant did not increase the auditory awakening threshold or cause next-day postural instability, and was not associated with rebound insomnia, withdrawal symptoms, or clinically meaningful impairment of next-day memory or driving performance.
Adis evaluation of lemborexant in the treatment of insomnia disorder Dual orexin receptor antagonist indicated for the treatment of adults with insomnia Reduces SOL and WASO and improves SE Does not impair the ability to awaken to sound Does not cause next-day postural instability Is not associated with rebound insomnia, withdrawal symptoms, or clinically meaningful impairment of nextday memory or driving performance Well tolerated, including over the longer term
Enhanced material for this Adis Drug Q&A can be found at https ://doi.org/10.6084/m9.figshare.12824534. * Hannah A. Blair [email protected] 1
Springer Nature, Private Bag 65901, Mairangi Bay, Auckland 0754, New Zealand
What is the rationale for using lemborexant in insomnia disorder? Insomnia is a common sleep disorder predominantly characterized by difficulties initiating and maintaining sleep, and/or waking up before the desired time [1, 2]. It is also associated with deficits in daytime functioning [1, 2], causing symptoms such as fatigue, low energy, mood disturbances, and reduced cognitive function (impaired attention, concentration, and memory) [2]. The main goals of insomnia treatment are improvement of sleep quality and daytime functioning [1]. The American College of Physicians recommends cognitive behavioral therapy for insomnia (CBT-I) as the first-line treatment for chronic insomnia, with pharmacological therapies recommended for patients who fail to respond to CBT-I alone [3]. However, many widely used sleep medications (e.g. benzodiazepines, non-benzodiazepine hypnotics or ‘Z-drugs’) have abuse potential and are associated with adverse effects, next-day impairment, dependence, and withdrawal symptoms [2–4]. In addition, although most patients with insomnia disorder have a mixed symptoms phenotype [2], few treatment options adequately address both sleep onset and sleep maintenance symptoms [2, 4]. For example, triazolam, zaleplon, and ramelteon are approved only for the treatment of sleep-onset insomnia, while flurazepam, quazepam and doxepin are approved
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