Daridorexant

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 side effects

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

Daridorexant side effects

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:

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

Warnings and Precautions

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:

What to avoid while taking Daridorexant?

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

Incidence not known

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

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.

Daridorexant

25 mg

(N=310)

%

Daridorexant

50 mg

(N=308)

%

Placebo

 

(N=309)

%

Nervous System Disorders
Headache* 6 7 5
Somnolence or fatigue* 6 5 4
Dizziness* 2 3 2
Gastro-intestinal disorders
Nausea* 0 3 2

*: The following terms were combined:

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.

More details

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

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