Understanding the Link Between Elinzanetant and Somnolence
Panelists discuss how there is no change in therapeutic indication based on this particular finding, though it may serve as a beneficial side effect for patients struggling with sleep difficulties.
Episode 7
The following transcript has been edited for clarity, style, and length.
Tara K. Iyer, MD: Based on the study data, elinzanetant may be associated with fatigue or somnolence. Dr Fiffick, can you please elaborate a little bit on this? And specifically, what considerations should we really bring up with our patients who are thinking about taking this medication?
Alexa Fiffick, DO, MBS, MSCP: In the original clinical trials, when they were looking at the safety associated with vehicular use, there is no change in the recommendation, so there was no appreciable somnolence that inhibited patients from driving safely. But, like we've said before, and like we'll say again, any medication that is new to you, we don't recommend that if you feel very somnolent that you go and start driving, you know, a 2-hour car ride away from your home or operating a tractor, or any other silly analogy that I can come up with. But currently it is a really well-accepted side effect because it helps so much with sleep for patients, so it ironically is very frequently seen as kind of a benefit instead of a negative, as far as side effects go.
Iyer: Absolutely. This aligns with how we approach many medications with potential sedative effects. When I counsel patients, I emphasize that we know this is a possible side effect, and we have ways to navigate it. One simple strategy is to start the medication at night rather than in the morning. Another approach is to begin on a weekend or a day when they don’t have work or major obligations, giving them a chance to see how it affects their energy levels and overall function.
If a patient does experience daytime fatigue, we can reassess and consider strategies like adjusting the timing of the dose or monitoring for other contributing factors. For most patients, this side effect tends to be mild and transient, but having an individualized approach ensures they feel comfortable with the medication.
Fiffick: I completely agree. I often suggest starting on a Friday or Saturday night, especially for patients with structured weekday routines, such as those who need to wake up early for work or manage a busy household. This allows them to observe how their body responds without immediate pressure to be fully alert and functional in the morning.
Overall, while fatigue or drowsiness can occur, it’s not a major concern for most patients, and many find it manageable—if not beneficial. The key is proactive counseling and helping patients tailor their approach to fit their lifestyle.
