Patient Information Leaflet: Daridorexant
Important: Please read this leaflet carefully before taking this medication.
What is Daridorexant?
Daridorexant is a medication used to treat insomnia by decreasing wakefulness. It works by blocking the action of orexin neuropeptides, which are involved in regulating wakefulness, thereby promoting sleep.
Drug Action
Daridorexant functions as an orexin OX1- and OX2-receptor antagonist. By inhibiting these receptors, it reduces alertness and helps individuals with insomnia fall and stay asleep.
Indications and Dosage
Indication:
– Daridorexant is prescribed for the short-term treatment of insomnia in adults who have experienced symptoms for at least 3 months, occurring at least 3 nights per week, and significantly affecting daytime functioning.
– It is recommended when:
– Cognitive Behavioural Therapy for Insomnia (CBTi) has been attempted but has not worked.
– CBTi is unavailable or unsuitable.
– The length of treatment should be as short as possible.
– Effectiveness should be assessed within 3 months. If insomnia persists without adequate response, treatment should be discontinued. If continued, periodic reassessment is necessary.
Dosage:
– Adults: 50 mg once daily, taken within 30 minutes before bedtime.
– Lower dose: 25 mg once daily may be prescribed in specific cases.
– Dose adjustments: If taking moderate CYP3A4 inhibitors, ciclosporin, or ciprofloxacin, a reduced dose of 25 mg is recommended.
Contraindications
Do not take Daridorexant if you have:
– Narcolepsy (a condition that causes excessive daytime sleepiness).
Cautions
Use Daridorexant with caution if you:
– Have a history of depression (monitor for worsening symptoms, including suicidal thoughts).
– Are aged 75 years or older (limited safety data available).
– Have a psychiatric illness (increased risk of suicidal ideation in pre-existing conditions).
Drug Interactions
– Daridorexant may interact with medications metabolized by liver enzymes.
– Inform your healthcare provider about all medications, including over the counter and herbal supplements, to prevent potential interactions.
Side Effects
Common or Very Common:
– Dizziness
– Fatigue
– Headache
– Nausea
Uncommon:
– Hallucinations
– Sleep paralysis
Seek medical attention if severe side effects occur.
Use in Pregnancy and Breastfeeding
Pregnancy:
– Daridorexant should be avoided unless absolutely necessary due to limited safety data.
Breastfeeding:
– Use with caution while breastfeeding.
– Monitor the breast-fed infant for sedation, poor feeding, and weight gain issues.
– Alternative treatments should be considered, especially for newborns.
Hepatic Impairment
– Severe impairment:Not recommended.
– Moderate impairment:Reduce dose to 25 mg once daily.
Directions for Administration
– Take Daridorexant with or without food.
– Taking it soon after a large meal may delay its sleep-inducing effect.
Prescribing and Dispensing Information
– Treatment duration should be as brief as possible.
– Effectiveness should be assessed within 3 months and periodically thereafter.
Patient and Carer Advice
– Patients and caregivers should understand proper administration and potential effects.
– Follow-up evaluations with healthcare professionals are recommended.
Driving and Skilled Tasks
– Drowsiness may persist the next day, especially in the initial days of treatment.
– Avoid skilled tasks such as driving or operating machinery for at least 9 hours after taking Daridorexant.
– Alcohol and other central nervous system (CNS) depressants can enhance its sedative effects.
National Funding/Access Decisions
– Consult your healthcare provider regarding funding and access to Daridorexant in your region.
Medicinal Forms and Pricing
– Daridorexant is available in tablet form.
– Pricing varies by location and pharmacy.
Other Drugs in Class
– Daridorexant belongs to the orexin receptor antagonist class, which includes similar medications used for insomnia treatment.
Conclusion
Daridorexant is a useful treatment for insomnia in patients who do not respond to cognitive behavioral therapy or when such therapy is unsuitable. It should be used with caution in patients with psychiatric illnesses, the elderly, and those with hepatic impairment. Regular assessment of its effectiveness is necessary to ensure continued benefit. Always consult a healthcare provider before starting or discontinuing treatment.
