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The following safety information outlines potential risks and precautions associated with the use of Dayvigo (lemborexant). It is crucial that you read these warnings carefully and discuss any concerns with your healthcare provider.

• Daytime Drowsiness: Dayvigo can cause significant drowsiness during the day, affecting your concentration, thinking, and reaction times. This effect may be pronounced in individuals aged 65 and older, those consuming alcohol while on the medication, or those using other sedative medications such as benzodiazepines. Increased risk factors include taking higher doses than recommended, combining with other sedatives, age 65 and above, alcohol consumption, and getting less than 7 hours of sleep.

• Mental Health Concerns: In some patients with depression, Dayvigo may exacerbate mental health issues, leading to worsening depression or increased risk of suicidal thoughts and behaviors. Individuals with a history of mental health issues, particularly depression and insomnia, should be closely monitored.

• Sleep Disturbances: Users may experience sleep paralysis, where they are temporarily unable to move or speak upon waking. There may also be instances of hallucinations or cataplexy-like symptoms, such as sudden muscle weakness triggered by emotions like laughter or stress. If you notice any of these symptoms, consult your healthcare provider.

• Abnormal Sleep Behaviors: Dayvigo can lead to complex sleep behaviors, such as sleepwalking, sleep-driving, or engaging in activities like cooking, eating, or having conversations while not fully awake.

• Breathing Difficulties: If you have pre-existing breathing conditions like sleep apnea or chronic obstructive pulmonary disease (COPD), inform your healthcare provider before using Dayvigo. It is unclear if this medication exacerbates these conditions.

Contraindications

• Narcolepsy: Patients diagnosed with narcolepsy should not use Dayvigo, as it may pose serious health risks. Always consult with your healthcare provider to ensure this medication is safe for you.

When taking this medication, some individuals may experience common side effects such as feeling sleepy or tired, headaches, and nightmares or unusual dreams. These effects are generally mild and often resolve on their own, but if they persist or become bothersome, it's advisable to consult a healthcare provider.

More serious side effects, while uncommon, should be addressed promptly. These include excessive daytime sleepiness, trouble focusing, and experiencing hallucinations. Some people may also report temporary leg weakness or episodes of sleep paralysis, where they are unable to move or speak for a few minutes while falling asleep or waking up.

Rarely, individuals may engage in abnormal sleep behaviors, such as sleepwalking, sleep-driving, or performing other activities like eating or making phone calls without full awareness. These actions can be dangerous, and it's important to seek medical advice if such behaviors occur. Mental health changes, including depression or suicidal thoughts, are also severe side effects that necessitate immediate medical attention.

In extremely rare cases, a serious allergic reaction may occur, presenting symptoms like rash, severe dizziness, or difficulty breathing. If you notice any signs of an allergic reaction, seek medical help right away. Always inform your healthcare provider about any side effects experienced for proper management and care.