What the label lists and what reports show
Daridorexant side effects
Daridorexant's FDA label: “The most common adverse reactions (reported in ≥ 5% of patients treated with QUVIVIQ and at an incidence ≥ than placebo) were headache and somnolence or fatigue.” FAERS holds 2,574 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nightmare (275 reports).
- No generic listed
- DEA Schedule IV
Check it at the source: the daridorexant FDA label on DailyMed (effective February 26, 2026, Idorsia Pharmaceuticals Ltd); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of QUVIVIQ?QUVIVIQ may cause serious side effects, including: See " What is the most important information I should know about QUVIVIQ? " Worsening depression and suicidal thoughts. Call your healthcare provider right away if you have any worsening depression or thoughts of suicide or dying. Temporary inability to move or talk (sleep paralysis) for up to several minutes, or hallucinations while you are going to sleep or waking up. Temporary weakness in your legs that can happen during the day or at night. Complex sleep behaviors such as sleepwalking, sleep driving, preparing and eating food, making phone calls, having sex, or doing other activities while not fully awake that you may not remember the next morning. Stop taking QUVIVIQ and call your healthcare provider right away if you experience a complex sleep behavior. […]
Source: FDA drug label, Idorsia Pharmaceuticals Ltd, effective February 26, 2026 (SPL set 3a2d1503-b816-40c9-9fac-7e03c5a3bcef), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (reported in ≥ 5% of patients treated with QUVIVIQ and at an incidence ≥ than placebo) were headache and somnolence or fatigue.
Table 1 Adverse Reactions Reported in ≥ 2% of QUVIVIQ-treated Patients and Greater than in Placebo-treated Patients in a 3-Month Placebo-Controlled Study (Study 1)
| Reaction | QUVIVIQ (N=310) % | QUVIVIQ (N=308) % | Placebo (N=309) % |
|---|---|---|---|
| Headache The following terms were combined: Headache includes: headache, tension… | 6 | 7 | 5 |
| Somnolence or fatigue | 6 | 5 | 4 |
| Dizziness | 2 | 3 | 2 |
| Nausea | 0 | 3 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following are discussed in detail in other sections of the labeling: CNS-Depressant Effects and Daytime Impairment [see Warnings and Precautions (5.1) ] Worsening of Depression/Suicidal Ideation [see Warnings and Precautions (5.2) ] Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms [see Warnings and Precautions (5.3) ] Complex Sleep Behaviors [see Warnings and Precautions (5.4) ] Patients with Compromised Respiratory Function [see Warnings and Precautions (5.5) ] The most common adverse reactions (reported in ≥ 5% of patients treated with QUVIVIQ and at an incidence ≥ than placebo) were headache and somnolence or fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Idorsia Pharmaceuticals Ltd at toll-free phone 1-833-400-9611 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 QUVIVIQ 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]). …
Source: FDA drug label, Idorsia Pharmaceuticals Ltd, effective February 26, 2026 (SPL set 3a2d1503-b816-40c9-9fac-7e03c5a3bcef), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,574 reports list daridorexant among the medicines taken, each a report of something that happened, not proof the medicine caused it; 67 are coded as a death and 263 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2023 (1,154, against a median of 1 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 19 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Daridorexant: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions