For guidance on the management of long-term insomnia, see Management of insomnia.

Where available, offer cognitive behavioural therapy for insomnia (CBTi) as the first-line treatment for long-term insomnia. 

Daridorexant

• Tablets 25mg, 50mg (£42.00 = 30 tablets)

Indications

• 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 not worked, is not available, or is unsuitable (in line with NICE TA922, see note 8)

Dose

• 50mg once per night, taken in the evening within 30 minutes before going to bed
  • Taking daridorexant soon after a large meal may reduce the effect on sleep onset.
• Hepatic impairment: no dose adjustment required in mild hepatic impairment. 25mg once per night in moderate hepatic impairment. Not recommended in severe hepatic impairment
• Renal impairment: no dose adjustment required.

Notes

1. As per NICE TA922, 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. Clinical data are available for up to 12 months of continuous treatment.
2. Treatment can be stopped without down-titration.
3. Elderly: Because of the general risk of falls in the elderly, daridorexant should be used with caution in this population, although clinical studies did not show an increase in the incidence of falls on daridorexant compared to placebo. Efficacy and safety data are limited in patients older than 75 years. No data are available in patients older than 85 years. For further information, see the SmPC.
4. Interactions: Concomitant use with strong CYP 3A4 inhibitors is contra-indicated. A reduced dose of 25mg once at night is recommended with concomitant use of moderate CYP 3A4 inhibitors. Efficacy may be reduced with concomitant use of moderate or strong CYP 3A4 inducers. Due to potentially additive effects with concomitant CNS-depressants, a dose adjustment of either daridorexant or the concomitant drug should be considered. Caution may also be required for medicines with a narrow therapeutic index. Check the BNF or SmPC for interactions before prescribing.
5. Abuse and dependence: There was no evidence of abuse or withdrawal symptoms indicative of physical dependence upon treatment discontinuation in clinical studies with daridorexant for insomnia. Individuals with a history of abuse or addiction to alcohol or other substances may be at increased risk for abuse of daridorexant and should be followed carefully. For further information, see the SmPC.
6. There is limited efficacy and safety data in patients with psychiatric comorbidities. Daridorexant has not been studied in patients with severe obstructive sleep apnoea and severe COPD. Exercise caution when prescribing for these patient populations. For further information, see the SmPC.
7. Sleep paralysis and hypnagogic/hypnopompic hallucinations, including vivid and disturbing perceptions, can occur with daridorexant, mainly during the first weeks of treatment. Symptoms similar to mild cataplexy have been reported with dual orexin receptor antagonists. Prescribers should explain the nature of these events to patients when prescribing daridorexant. For further information, see the SmPC.
8. NICE TA922: Daridorexant (Quviviq) 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 (October 2023), only if:
   1. cognitive behavioural therapy for insomnia (CBTi) has been tried but not worked, or
   2. CBTi is not available or is unsuitable.