QUVIVIQ SIDE EFFECTS
- Generic Name: daridorexant tablets
- Brand Name: Quviviq
SIDE EFFECTS
The following are discussed in detail in other sections of the labeling:
- CNS-Depressant Effects and Daytime Impairment
- Worsening of Depression/Suicidal Ideation
- Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms
- Complex Sleep Behaviors
- Patients with Compromised Respiratory Function
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]). Study 1 evaluated 50 mg and 25 mg doses of QUVIVIQ, while Study 2 evaluated a 25 mg dose and a 10 mg dose of QUVIVIQ. The 10 mg dose is not an approved dose. A total of 1232 patients (including approximately 40% elderly patients [> 65 years old]), received QUVIVIQ 50 mg (N = 308); 25 mg (N = 618); or 10 mg (an unapproved dose) (N = 306). A total of 576 patients were treated with QUVIVIQ 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 headache.
Table 1 shows adverse reactions that occurred in at least 2% of patients treated with QUVIVIQ and more frequently than in patients who received placebo in Study 1.
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)
| QUVIVIQ 25 mg (N=310) % |
QUVIVIQ 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: 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 |
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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 QUVIVIQ 25 mg and 50 mg, respectively, compared to no reports for placebo.
- Hypnagogic and hypnopompic hallucinations were reported in 0.6% of patients receiving QUVIVIQ 25 mg compared to no cases with QUVIVIQ 50 mg or placebo.
SRC: NLM .