Leslie Citrome, MD, MPH, comments on long-term data for daridorexant, suvorexant, and lemborexant.
Paul Doghramji, MD, FAAFP: So far, Leslie, you’ve talked about the study 1 and study 2 with data at 1 month and 3 months with daridorexant 10, 25, and 50 mg. You’ve said the 10 mg isn’t available. Has there been any duration increase of more than 3 months according to clinical trials?
Leslie Citrome, MD, MPH: Absolutely. When clinical trials are done, they’re usually placebo controlled. They’re done for a relatively short period of time, and then ordinarily there’s an extension study. There was a 40-week extension study giving us data up to a year. In that extension study, people continued to receive daridorexant. Those who were originally on placebo had an opportunity to be re-randomized to also receive daridorexant. That’s how you get people to agree to be in these longer-term extension studies. All the benefits that were observed in the first 3 months persisted through the 40-week extension study. We have data demonstrating that continuation in subjective total sleep time remaining improved, and the existent sleeping domain remaining improved as well.
Paul Doghramji, MD, FAAFP: They maintained all this over time, and there did not seem to be a deterioration of the medications’ benefit through the night and during the day. But these are observational, correct?
Leslie Citrome, MD, MPH: Clearly there was no loss of effect of daridorexant. This would be something of keen interest when looking at a hypnotic because in the past we’ve been burned by this. In the past with benzodiazepines and Z-drugs, we’ve seen a falloff of the clinical efficacy of the older hypnotics. This wasn’t observed with DORAs [dual orexin receptor antagonists], including daridorexant.
Paul Doghramji, MD, FAAFP: Let’s bring suvorexant and lemborexant back into the picture. Let’s talk about their long-term data and their risk of treatment discontinuation. Do we have any information there?
Leslie Citrome, MD, MPH: Yes. Overall, the DORAs are well tolerated. The rates of discontinuation due to adverse events are pretty close to what was seen with placebo or lower than what was seen with placebo. That’s very encouraging. There may be some dose-related issues with agents depending on their characteristics, so the dosing is different for suvorexant-lemborexant and daridorexant.
Transcript edited for clarity