A Fresh Option for Insomnia in Primary Care

Written by Dr Feroz Mavani

MBChB (Hons), MRCGP, PGDipCert (Digital Health Leadership)

GP Partner & Family Medicine Consultant | NHS Clinical Researcher | Principal Investigator

Peterborough, England, UK

Insomnia is one of the most frequent and frustrating presentations in general practice. Patients rarely present with “sleep latency of 90 minutes” as a neat clinical metric. They present exhausted, irritable, cognitively dulled and often anxious about the long-term consequences of not sleeping. Chronic insomnia affects cardiovascular health, mental wellbeing, occupational performance and quality of life. It is common, persistent and difficult to manage well.

For years, pharmacological options have felt unsatisfactory. Benzodiazepines and Z-drugs can be effective in the short term but bring well-recognised risks of tolerance, dependence, falls and next-day sedation. As GPs, we are frequently balancing short-term relief against long-term harm.

In 2023, NICE recommended daridorexant as a treatment option for chronic insomnia in adults under defined circumstances. That decision reflected a meaningful shift in how we may approach pharmacological sleep management in primary care.

A Different Mechanism: Targeting Wakefulness

Daridorexant is a dual orexin receptor antagonist. Orexins are neuropeptides produced in the hypothalamus that promote wakefulness and stabilise arousal. Rather than globally depressing central nervous system activity, daridorexant selectively blocks the orexin system, reducing the biological drive to remain awake.

Mechanistically, this represents a conceptual advance. Instead of forcing sedation, it modulates the wake pathway itself. From a GP perspective, that distinction matters. Many patients are wary of “sleeping tablets” because of prior adverse experiences. Being able to explain that this therapy works differently, and is designed for longer-term use in appropriate patients, changes the tone of that conversation.

The Evidence Base Behind Approval

The pivotal clinical trials that informed regulatory and NICE approval demonstrated improvements in sleep onset, sleep maintenance and patient-reported daytime functioning compared with placebo. Importantly, benefits were sustained for up to 12 months in trial settings.

Daytime function is particularly relevant in primary care. Insomnia is not just about the number of hours slept; it is about concentration at work, emotional regulation and safety while driving. The inclusion of validated daytime functioning measures strengthened the clinical relevance of the data.

The evidence does, however, remain strongest within a 12-month window. As with most newer therapies, very long-term real-world data are still emerging. That is not unusual, but it does mean prescribing should remain deliberate and reviewed.

What NICE Recommends

NICE guidance places daridorexant within a structured pathway:

• For adults with chronic insomnia lasting at least three months.

• Where symptoms significantly impair daytime functioning.

• After sleep hygiene advice and cognitive behavioural therapy for insomnia (CBTi) have been tried and have not worked, or where CBTi is unsuitable or unavailable.

• With review after three months, continuing only if there is clear benefit.

This is appropriately cautious. It reinforces that pharmacological treatment should not displace behavioural and psychological approaches. At the same time, it acknowledges a practical reality in UK general practice: access to CBTi is variable, and some patients remain significantly impaired despite best non-drug interventions.

Reflections from the Consulting Room

In real life, insomnia rarely exists in isolation. It intersects with anxiety, depression, chronic pain, menopause, shift work and social stress. Prescribing a tablet without addressing these drivers is rarely sufficient.

That said, there are patients for whom insomnia becomes self-perpetuating and debilitating despite appropriate management of comorbidities. For this group, having an option that is NICE-recommended, mechanistically targeted and supported by 12-month data is clinically meaningful.

Daridorexant is not a panacea. It requires review. It requires patient selection. It requires ongoing evaluation of benefit versus burden. But in a landscape historically dominated by short-term sedatives with clear limitations, this represents a measured and evidence-based step forward.

From a GP perspective, that balance matters. Innovation is welcome, but only when it is grounded in robust data and integrated into thoughtful prescribing practice.

Reference

National Institute for Health and Care Excellence (NICE), 2023. Daridorexant for treating long-term insomnia (TA922).London: NICE. Available at: https://www.nice.org.uk/guidance/ta922