1 Recommendations

1.1 Daridorexant is recommended for treating insomnia in adults with symptoms lasting for 3 nights or more per week for at least 3 months, and whose daytime functioning is considerably affected, only if:

  • cognitive behavioural therapy for insomnia (CBTi) has been tried but not worked, or

  • CBTi is not available or is unsuitable.

1.2 The length of treatment should be as short as possible. Treatment with daridorexant should be assessed within 3 months of starting and should be stopped in people whose long-term insomnia has not responded adequately. If treatment is continued, assess whether it is still working at regular intervals.

1.3 This recommendation is not intended to affect treatment with daridorexant that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

CBTi is the standard first treatment for people with long-term insomnia after sleep hygiene advice is offered. But access to CBTi varies across the UK, and for some people it does not work or is unsuitable. For this evaluation, the company asked for daridorexant to be considered as a first treatment when CBTi is not available or is unsuitable, and as a second treatment when CBTi has been tried but not worked. This does not include everyone who it is licensed for.

Clinical trial evidence shows that daridorexant improves symptoms of insomnia compared with placebo for 12 months. The effects if it's taken for longer than this are unknown. A condition of the marketing authorisation is that treatment with daridorexant should be reviewed within 3 months and regularly after that.

The most likely cost-effectiveness estimate is within what NICE considers an acceptable use of NHS resources. So, daridorexant is recommended for routine use in the NHS.

  • National Institute for Health and Care Excellence (NICE)