Title: Daridorexant for treating insomnia disorder [ID3774]
Funder: Department of Health and Social Care

Abstract: Insomnia is difficulty in getting to sleep, difficulty maintaining sleep, early wakening, or non-restorative sleep which occurs despite adequate opportunity for sleep. It results in impaired daytime functioning. Daytime symptoms typically include poor concentration, mood disturbance, and fatigue. Sleep disturbance in the absence of daytime impairment is not considered to be insomnia disorder. Insomnia is classed as short-term when symptoms occur for less than 3 months and chronic when symptoms persist for more than 3 months. Insomnia disorder refers to chronic insomnia. _x000D_ _x000D_ Identifying sleep patterns in the UK is difficult due to the lack of regular, high quality surveys. However, one study in the UK, found that the prevalence of people reporting sleep difficulties increased slightly from 35% to 39% between 1993 and 2007. [1] Although, a systematic literature review noted that only 6% of people met the criteria for an insomnia diagnosis. [2] Prevalence of insomnia is 1.5 to 2 times higher in females than males and is most common in older adults. [3] In addition, insomnia is associated with comorbid conditions such as chronic obstructive pulmonary disease, heart failure, chronic pain, and psychiatric conditions (depression, anxiety, substance abuse, and post-traumatic stress disorder). _x000D_ _x000D_ NICE Clinical Knowledge Summary (CKS) for insomnia recommends sleep hygiene, which is increasing awareness of factors that may be detrimental or beneficial to sleep, for both acute and chronic insomnia. Cognitive behavioural therapy for insomnia (CBT-I) is recommended as first-line treatment for people with chronic or acute insomnia for whom sleep hygiene measures have failed and insomnia is not likely to resolve soon. Short-term pharmacotherapy with non-benzodiazepine hypnotic medication can be considered as a temporary adjunct to behavioural and cognitive treatments for people with chronic insomnia who have severe symptoms or an acute exacerbation. Short term pharmacotherapy can also be an option for people with acute insomnia if sleep hygiene measures fail and daytime impairment is severe causing significant distress. NICE technology appraisal 77 recommends hypnotic drugs zolpidem or zopiclone as treatment options for insomnia in adults. Benzodiazepines (including nitrazepam, loprazolam, lormetazepam and temazepam) or melatonin for those aged 55 or older may also be used._x000D_ _x000D_ References_x000D_ 1 Calem M, Bisla J, Begum A et al. (2012) Increased Prevalence of Insomnia and Changes in Hypnotics Use in England over 15 Years: Analysis of the 1993, 2000, and 2007 National Psychiatric Morbidity Surveys. Sleep 35(3): 377-384._x000D_ 2 Ohayon M (2002) Epidemiology of insomnia: what we know and what we still need to learn. Sleep Medicine Reviews 6(2), 97-111._x000D_ 3 Wilson S, Anderson K, Baldwin D et al. (2019) British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders: An update. Journal of Psychopharmacology 33(8), 923-947.

Lay abstract: To appraise the clinical and cost effectiveness of daridorexant within its marketing authorisation for treating insomnia disorder.

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: NEUROLOGICAL