From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Dayvigo (lemborexant) is contraindicated in patients with narcolepsy, as it may worsen their condition by further promoting sleep, and should also be avoided in individuals with a history of complex sleep behaviors, severe hepatic impairment, and during co-administration with strong CYP3A inhibitors. The medication works by blocking orexin receptors in the brain, which helps regulate the sleep-wake cycle, but this mechanism can be problematic in conditions like narcolepsy where orexin function is already compromised 1.
Key Contraindications
- Narcolepsy: due to the potential worsening of the condition by further promoting sleep 1
- History of complex sleep behaviors: such as sleepwalking or sleep driving, as lemborexant may increase the risk of these events 2
- Severe hepatic impairment: due to potential drug accumulation and increased risk of adverse effects 2
- Co-administration with strong CYP3A inhibitors: such as ketoconazole, clarithromycin, or itraconazole, as these drugs can significantly increase lemborexant blood levels, enhancing side effects 2
- Hypersensitivity to lemborexant or any components of the formulation: as this can lead to allergic reactions and other adverse effects 2 ### Additional Considerations
- Pregnancy: Dayvigo should be avoided during pregnancy unless benefits clearly outweigh risks, and caution is advised for nursing mothers 2
- Nursing mothers: caution is advised due to the potential for lemborexant to be excreted in breast milk and affect the infant 2 A recent postmarketing observational study found that lemborexant was generally safe and effective in insomnia patients, with an efficacy rate of 80.83% and a low incidence of adverse drug reactions 3. However, the study did not specifically address the contraindications and precautions listed above.
Important Safety Information
- Somnolence: a common adverse effect of lemborexant, which can increase the risk of accidents and injuries 3
- Parasomnia: including sleepwalking and sleep driving, which can occur in patients taking lemborexant 2
- Narcolepsy and associated conditions: lemborexant can worsen these conditions and should be avoided in patients with a history of narcolepsy or cataplexy 1