daridorexant hydrochloride: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
daridorexant hydrochloride: clinical details
Prescribing considerations
- Assess other causes of insomnia, including psychiatric illness, sleep apnoea, substance use and medicines that disturb sleep.
- Use caution with depression, suicidal thoughts, psychiatric comorbidity, severe COPD, previous substance misuse and increased falls risk.
- Advise about next-morning impairment, alcohol, hazardous activities, sleep paralysis, hallucinations and sleepwalking.
- Use in severe hepatic impairment is not recommended.
- Renal impairment does not materially alter exposure.
Contraindications and cautions
- Hypersensitivity to daridorexant or an excipient
- Narcolepsy
- Concomitant use of a strong CYP3A4 inhibitor
Monitoring
- Clinical benefit and daytime functioning
- Morning somnolence, dizziness, falls and driving safety
- Mood deterioration or suicidal thoughts
- Sleep paralysis, hallucinations, nightmares or sleepwalking
- Misuse in people with a history of alcohol or substance dependence
- Respiratory symptoms in severe pulmonary disease
Clinical pharmacology
Daridorexant is an equipotent antagonist at orexin-1 and orexin-2 receptors. It is rapidly absorbed, highly protein-bound, primarily metabolised by CYP3A4 and has an approximate terminal half-life of 8 hours.
Formulation and product differences
- The selected presentation is a light-orange, arc-triangle film-coated tablet.
- It is essentially sodium-free and contains mannitol, cellulose derivatives, povidone, silica, magnesium stearate and a coloured film coating.
- No special storage conditions are required.
daridorexant hydrochloride preparations and strengths
Tablet
Route: Oral
Strengths: 25 mg, 50 mg
daridorexant hydrochloride interactions
A medication review is important before starting daridorexant.
Strong CYP3A4 inhibitors, including itraconazole, clarithromycin and ritonavir
They can substantially increase daridorexant exposure and must not be used with it.
Moderate CYP3A4 inhibitors, including erythromycin, ciprofloxacin, diltiazem and ciclosporin
They increase daridorexant exposure, so the prescription requires clinical review.
Moderate or strong CYP3A4 inducers, including rifampicin and efavirenz
They can lower daridorexant exposure and reduce its effect.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.