4.7.1 Insomnia

Daridorexant is to be used for treating long-term insomnia in line with NICE TA922 and the following information. Further guidance is being developed to support prescribing.

Prior to initiation of daridorexant patients should be screened for the following:

• Depression
• Generalised anxiety disorder
• Panic disorder
• Obsessive compulsive disorder
• Post traumatic stress disorder
• Social anxiety disorder
• Chronic Fatigue Syndrome
• Chronic Pain
• Irritable bowel syndrome

If any of the above are suspected the patient should be referred to Talking Therapies (for access to CBT) in the first instance.

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.

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.

The initiating clinician is responsible for the 3 month assessment of efficacy.

Contraindications:

• Hypersensitivity to any of the ingredients or excipients.
• Narcolepsy
• Concomitant use of CYP 3A4 inhibitors

Precautions include:

• Elderly - use with caution. Limited data is available in those >75 years and no data >85 years.
• Severe obstructive sleep apnoea (OSA) and severe COPD (FEV1 < 40% of predicted)- a lack of data in this patient population.
• Pregnancy/ lactation- lack of data, seek specialist advice.
• Patients with psychiatric co-morbidities
  • In primarily depressed patients treated with hypnotics, worsening of depression and suicidal thoughts and actions have been reported. As with other hypnotics, daridorexant should be administered with caution in patients exhibiting symptoms of depression. There is limited data in patients with psychiatric co-morbidities.

Therefore, for patients under Kent and Medway partnership trust (KMPT) initiation should be within the KMPT Service. KMPT will have the responsibility to review at 3 months and 12 months. Ongoing prescribing in primary care can continue following initiation by a KMPT clinician.