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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Draft guidance consultation

    Closed for comments This consultation ended on at   Request commenting lead permission

    1 Recommendations

    1.1 Daridorexant is not recommended, within its marketing authorisation, for treating insomnia in adults with symptoms for at least 3 months and a considerable effect on daytime functioning.

    1.2 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

    Cognitive behavioural therapy for insomnia (CBTi) is currently the standard first-line treatment for people with long-term insomnia after sleep hygiene advice is offered. But access to CBTi varies across the UK, sometimes it does not work, and sometimes it is unsuitable. Daridorexant may be another option for these people.

    Clinical trial evidence shows that daridorexant improves symptoms of insomnia compared with placebo at 12 months. But the effects if it's taken for longer than this are unknown. There are also uncertainties in the economic model. The most likely cost-effectiveness estimate is above what NICE normally considers an acceptable use of NHS resources. So, daridorexant is not recommended.