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This drug safety information outlines vital precautions and potential risks associated with the use of Quviviq (daridorexant). Please read carefully and discuss any concerns with your healthcare provider.

• Daytime Drowsiness: Quviviq (daridorexant) may cause significant drowsiness, impacting alertness and concentration. This is more pronounced in individuals aged 65 or older, or when combined with alcohol or other sedatives. To minimize these effects, ensure you sleep for at least 7 hours after taking the medication. Risks include: high doses, age 65+, alcohol consumption, concurrent use of sedatives, and insufficient sleep.

• Mental Health Effects: For some, Quviviq (daridorexant) may exacerbate depression or trigger suicidal thoughts, especially in those with a history of mental health issues such as insomnia or depression. Monitor mood changes and consult your doctor if you experience any concerning symptoms.

• Sleep Disturbances: Users may encounter sleep paralysis, hallucinations, or cataplexy-like symptoms—characterized by sudden muscle weakness linked to strong emotions. If you or others observe these effects, contact your healthcare provider.

• Unusual Sleep Activities: Quviviq (daridorexant) may lead to engaging in activities while asleep, such as sleepwalking, sleep-driving, or other complex behaviors. Be vigilant and report any such incidents to your prescriber.

• Breathing Problems: If you have existing breathing difficulties like sleep apnea or COPD, inform your healthcare provider before starting Quviviq (daridorexant), as its effects on such conditions are not fully known. A thorough evaluation will determine if this medication is suitable for you.

• Contraindication: Quviviq (daridorexant) should not be used if you have narcolepsy, due to serious health risk concerns.

Always adhere to your healthcare provider's guidance and report any adverse reactions or side effects promptly.

When taking this medication, it's common to experience mild side effects such as headaches, which occur in up to 7% of individuals, and sleepiness or fatigue in up to 6%. These side effects are generally not serious but should be discussed with your healthcare provider if they persist or worsen. Dizziness and nausea are also reported by some users and warrant attention if they become bothersome.

More serious side effects, though rare, require immediate medical attention. These include excessive daytime sleepiness, difficulty focusing, or staying alert. It's crucial to be vigilant for any mental or mood changes, such as depression or suicidal thoughts, and seek urgent help if they manifest. Additionally, abnormal sleep behaviors have been noted, including sleepwalking, sleep-driving, or engaging in activities while not fully awake. Sleep paralysis, a temporary inability to move or talk while waking, is another potential serious side effect.

A very serious allergic reaction to this medication is rare but requires immediate medical assistance if symptoms like rash, severe dizziness, itching or swelling (especially of the face, tongue, or throat), or trouble breathing occur. Always consult your healthcare provider if you notice any other effects not listed here. Your risk increases if you consume alcohol or other drowsiness-inducing medications while taking this drug.