Quviviq Adverse Reactions

Summary of safety profile: The most frequently reported adverse reactions were headache and somnolence.
The majority of adverse reactions were mild to moderate in intensity. No evidence of a dose-relationship for the frequency or severity of adverse reactions was observed. The adverse reaction profile in elderly subjects was consistent with younger subjects.
Tabulated list of adverse reactions: Table 3 shows adverse reactions that occurred in Study 1 and Study 2.
The frequency of adverse reactions is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
The safety of daridorexant was evaluated in three placebo-controlled Phase 3 clinical studies. A total of 1847 subjects (including approximately 40% elderly subjects [≥ 65 years old]) received daridorexant 50 mg (N = 308); 25 mg (N = 618); or 10 mg (N = 306), or placebo (N = 615). A total of 576 subjects were treated with daridorexant for at least 6 months and 331 for at least 12 months. (See Table 3.)

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Description of selected adverse reactions: Somnolence: Somnolence was reported in 3% and 2% of subjects treated with daridorexant 25 mg and 50 mg, respectively, compared to 2% of subjects on placebo.
Sleep paralysis and hallucinations: Sleep paralysis was reported in 0.5% and 0.3% subjects receiving daridorexant 25 mg and 50 mg, respectively, compared to no reports for placebo. Hypnagogic and hypnopompic hallucinations were reported in 0.6% subjects receiving daridorexant 25 mg compared to no cases with daridorexant 50 mg or placebo. Sleep paralysis and hallucinations occur mainly during the first weeks of treatment.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.