Daridorexant

• Generic Name: daridorexant
• Dosage Form: tablets, for oral use
• Brand name: Quviviq

Medically reviewed by A Ras MD.  Updated on  March 27, 2022.

What is Daridorexant?

Daridorexant side effects are unwanted reactions that may be experienced while using this medication.

Daridorexantis a prescribed medicine for adults who are having trouble getting asleep or remaining in bed (insomnia).

It isn’t clear whether this medication is suitable and safe to use in children.

Daridorexant is a federally-controlled substance that is federally controlled (Schedule Pending) because it could be misused and result in dependence.

Make sure to keep Daridorexant in a secure location to protect it from misuse and misuse. Giving away or selling this medication can cause harm to other people and is against the law.

Description

Daridorexant contains daridorexant, an orexin receptor antagonist. The chemical name of daridorexant hydrochloride is (S)-(2-(5-chloro-4-methyl-1H-benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl)(5methoxy-2-(2H-1,2,3-triazol-2-yl)phenyl)methanone hydrochloride. The molecular formula is C₂₃H₂₃N₆O₂Cl * HCl. The molecular weight is 487.38 g/mol.

Daridorexant hydrochloride is a white to light yellowish powder that is very slightly soluble in water.

Daridorexant tablets are intended for oral administration. Each film-coated tablet contains 27 mg or 54 mg of daridorexant hydrochloride equivalent to 25 mg or 50 mg of daridorexant, respectively. The inactive ingredients are croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, povidone, and silicon dioxide.¶

In addition, the film coating contains the following inactive ingredients: glycerin, hypromellose, iron oxide black, iron oxide red, microcrystalline cellulose, talc, titanium dioxide, and, in the 50 mg tablet only, iron oxide yellow.

Mechanism of Action

The mechanism of action of daridorexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system plays a role in wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.¶

Important information

Daridorexant may cause serious side effects, including:

• A decrease in awareness and alertness. The morning following the intake of this medication the capacity to safely drive and be able to think clearly might be reduced. It is also possible to experience euphoria throughout the day.
  • Do not take any more this medication than the amount prescribed.
  • Do not use this medication unless you’re in a position to sleep for a whole night (at least seven hours) before you are physically active.
  • Take Daridorexant in the evening, at least 30 minutes prior to going to go to bed.

Read about Qviviq’s side adverse effects for more details about the side effects.

Warnings and Precautions

• CNS-Depressant Effects and Daytime Impairment: Impairs alertness and motor coordination including morning impairment. Risk increases when used with another central nervous system (CNS)  depressants. For patients taking this medication, caution against next-day driving and other activities requiring complete mental alertness.

• Worsening of Depression/Suicidal Ideation: Worsening of depression or suicidal thinking may occur.
• Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms: May occur with the use of this medication.
• Complex Sleep Behaviors: Behaviors including sleepwalking, sleep-driving, and engaging in other activities while not fully awake may occur. Discontinue immediately if complex sleep behavior occurs.
• Compromised Respiratory Function: Effect on respiratory function should be considered.

Who shouldn’t take Daridorexant?

Avoid taking this medication when you sleep frequently at unplanned moments (narcolepsy).

Before taking Daridorexant

Before taking this medication tell your physician about your medical issues, including the following:

• are afflicted with depression, mental illness, or suicidal ideas or behaviors
• Have a history of substance or alcohol abuse, addiction or addiction
• Have a history of sudden beginning in muscles weakness (cataplexy)
• Have a history of nighttime sleepiness
• suffer from breathing or lung problems have breathing or lung problems, such as sleep apnea
• Have liver issues
• You are expecting or planning to get pregnant. It’s not clear whether this medication may cause harm to your baby.
  • Pregnancy Registry: There’s a registry of pregnant women who have been affected by this medication in pregnancy. The aim of this registry is to gather data on the health of both you and your child. For more information, or to be a part of the registry, contact 1-833-405-9611. Discuss with your doctor the risks for your unborn baby’s health when you are taking this medication during your pregnancy.
• If you are nursing or planning to or plan to. It’s not clear whether this medication is absorbed into milk. Discuss with your healthcare professional the best method to feed your child while you are undergoing treatment.

What to avoid while taking Daridorexant?

• Avoid drinking alcohol when taking Daridorexant. It may increase your effects from alcohol which could be harmful.
• It is possible to feel sleepy the next day following having taken Daridorexant.
  • Don’t drive, operate machinery that is heavy, do things that are dangerous, or perform other tasks that require clear thought if you’ve taken Daridorexant according to prescribed, but you are not feeling completely awake, have taken Daridorexant but have had less than a complete night of rest (at least 7 hours) or if you have used more Daridorexant that was recommended by your physician.

Daridorexant side effects

A drug may have some undesired side effects in addition to its intended effects. Although not all of these side effects are likely to occur, if they do, medical treatment may be required.

If any of the following side effects appear, notify your doctor right away:

More common

• Relaxed and calm
• sleepiness
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• unusually deep sleep
• unusually long duration of sleep

Incidence not known

• Changes in behavior
• discouragement
• feeling sad or empty
• irritability
• lack of appetite
• nausea
• loss of interest or pleasure
• seeing, hearing, or feeling things that are not there
• thoughts of killing oneself
• trouble concentrating

Some Daridorexant side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Dizziness
• feeling of constant movement of self or surroundings
• headache
• nausea
• chest heaviness
• sensation of spinning

Other Daridorexant side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

This is not the only list of the possible Daridorexant side effects. Contact your doctor for advice regarding medical possible side effects. You can report any side effects to the FDA via 800-FDA-1088.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.

The safety of Daridorexant was evaluated in three placebo-controlled clinical studies (two 3-month studies of identical design [Study 1 and Study 2], and a 9-month extension study [Study 3]). Study 1 evaluated 50 mg and 25 mg doses of Daridorexant, while Study 2 evaluated a 25 mg dose and a 10 mg dose of Daridorexant. The 10 mg dose is not an approved dose. A total of 1232 patients (including approximately 40% elderly patients [> 65 years old]), received Daridorexant 50 mg (N = 308); 25 mg (N = 618); or 10 mg (an unapproved dose) (N = 306). A total of 576 patients were treated with Daridorexant for at least 6 months and 331 for at least 12 months.

Most Common Adverse Reactions

The most common reported adverse reaction (in at least 5% of patients and greater than placebo) during double-blind treatment in Study 1 was a headache.

Table 1 shows adverse reactions that occurred in at least 2% of patients treated with Daridorexant and more frequently than in patients who received placebo in Study 1.

*: The following terms were combined:

• Headache includes: headache, tension headache, migraine, migraine with aura, head discomfort
• Somnolence or fatigue includes: somnolence, sedation, fatigue, hypersomnia, lethargy
• Dizziness includes: dizziness, vertigo, labyrinthitis
• Nausea includes: nausea, vomiting, procedural nausea

Other Adverse Reactions Observed During Clinical Trials (Study 1 and Study 2)

Other adverse reactions of < 2% frequency but greater than placebo are shown below. The following do not include adverse reactions 1) for which a drug cause was remote, 2) that were so general as to be uninformative, or 3) that were not considered to have clinically significant implications.

• Sleep paralysis was reported in 0.5% and 0.3% of patients receiving Daridorexant 25 mg and 50 mg, respectively, compared to no reports for placebo.
• Hypnagogic and hypnopompic hallucinations were reported in 0.6% of patients receiving Daridorexant 25 mg compared to no cases with Daridorexant 50 mg or placebo.

More details

Always consult your doctor to confirm that the information provided on this site is appropriate to your particular situation.