Daridorexant: Effects, Side Effects

How does daridorexant work?

Daridorexant is the first active ingredient approved in Europe from the group of orexin receptor antagonists. Orexins are messenger substances produced naturally in the body that influence our eating behavior and sleep patterns. If they bind to their receptor, we stay awake longer.

Daridorexant blocks this receptor and thus has an indirect sleep-promoting effect. This distinguishes the active ingredient from other sleeping pills, which primarily have a direct sedative (depressant, calming) effect.

What are the side effects?

Common side effects of daridorexant involve the nervous system. They manifest as headache, fatigue, drowsiness, and dizziness.

Some people become nauseous after taking daridorexant.

Studies to date indicate that daridorexant is unlikely to cause physical or psychological dependence. Withdrawal symptoms after discontinuation were also much milder than with other sleep aids.

Daridorexant limits responsiveness. This possibly impairs the ability to actively participate in road traffic and operate machinery. This is especially true if you have also been drinking alcohol.

For more information about possible side effects, see the package leaflet that came with your daridorexant medicine. Contact your doctor or pharmacist if you develop or suspect any unwanted side effects.

What is daridorexant approved for?

Daridorexant has approval in Germany and Switzerland for the treatment of adults with sleep disorders. The symptoms must have been present for at least three months and have a considerable impact on daytime activity.

How to take daridorexant

Daridorexant is available in the form of film-coated tablets. The recommended dosage is one tablet (equivalent to 50 milligrams of daridorexant) 30 minutes before bedtime. For some patients, 25 milligrams is sometimes sufficient.

The maximum daily dose is 50 milligrams.

You can take the tablet with a meal or independently.

When should you not take daridorexant?

You should generally not use daridorexant in the following cases:

  • if you are hypersensitive or allergic to the active ingredient or any of the other ingredients of the medication
  • narcolepsy (neurological disorder in which sleep-wake regulation in the brain is disturbed)
  • concomitant use of agents that strongly inhibit the enzyme cytochrome P450 3A4 (CYP3A4), e.g., the antifungal drug itraconazole, the antibiotic clarithromycin, and the HIV drug ritonavir
  • Pregnancy and lactation (missing data)

These interactions may occur with daridorexant.

Moderate inhibitors of the enzyme CYP3A4 slow down the breakdown of daridorexant – like strong inhibitors – but less massively. Therefore, they may be taken at the same time as daridorexant. However, the doctor will then reduce its dose.

Moderate CYP3A4 inhibitors include:

  • diltiazem and verapamil (medicines for high blood pressure and coronary artery disease)
  • erythromycin (antibiotic)
  • Ciprofloxacin (antibiotic)
  • Ciclosporin (immunosuppressant, used in autoimmune diseases and organ transplantation)
  • Fluconazole (antifungal agent)

Refrain from drinking grapefruit and grapefruit juice in the evening if you are taking daridorexant. The ingredients of grapefruit also inhibit the enzyme CYP3A4.

How to obtain medication with daridorexant

Daridorexant is available by prescription in Germany and Switzerland. No medicines containing this active ingredient are currently registered in Austria.