Michael Thorpy, MD, director, Sleep-Wake Disorders Center, Montefiore Medical Center, and professor of neurology, Albert Einstein College of Medicine, speaks on the efficacy of solriamfetol observed in patients with excessive daytime sleepiness associated with narcolepsy, and which patient groups may best benefit from this therapy.
The efficacy of solriamfetol (Sunosi) was shown to compare favorably, and at times better, vs other past medications for excessive daytime sleepiness associated with narcolepsy, with women of childbearing age and patients with narcolepsy type 2 serving as notable groups who may best benefit from the therapy, said Michael Thorpy, MD, director, Sleep-Wake Disorders Center, Montefiore Medical Center, and professor of neurology, Albert Einstein College of Medicine.
Can you speak on the START study findings presented at SLEEP 2021?
Solriamfetol is a drug that's a dopamine/norepinephrine reuptake inhibitor, and its main effect is in terms of producing improvements in daytime sleepiness. It does not have an effect on nocturnal sleep or on cataplexy.
So, the study that was done was looking at its effect on daytime sleepiness, and showed it to be a very effective agent in terms of producing improvements in excessive sleepiness as measured both objectively as well as subjectively. So, the Maintenance of Wakefulness Test showed significant improvements with solriamfetol, as did the Epworth Sleepiness Scale, a subjective scale—it showed that there were major improvements.
So, the results of the study showed that solriamfetol really compares very favorably with other alerting medications that we’ve had in the past and that some of the measures are, in fact, better than prior medications.
What implications may these findings have for clinicians treating patients with narcolepsy?
I think these findings indicate that we have a new medication that is effective for the treatment of excessive sleepiness in patients with narcolepsy. It may need to be combined with other medications for the treatment of cataplexy—such as oxybate, pitolisant, or off-label antidepressant use—but it will be a medication that will be combined with these other medications for the treatment of patients who have type 1 narcolepsy, which is associated with cataplexy.
By itself, it can be useful for treating patients who have type 2 narcolepsy who just have just daytime sleepiness—this medication can be useful for them. The other thing about the medication is that it has a side effect profile that's a little bit different from some of the other medications that are available. It’s not metabolized in the liver so therefore doesn't interfere with oral contraceptive agents that women of childbearing age may be taking. So, from this point of view, it differs from the modafinil medications and pitolisant, which do interfere with oral contraceptives. So, it may have some advantages for certain patient groups over current medications, from the point of view of that adverse effect potential.
Thorpy M, Hyman D, Parks G, et al. Solriamfetol Titration & AdministRaTion (START): Characteristics of patients with narcolepsy and solriamfetol prescriber rationale. Sleep. 2021;44(suppl 2):A190. doi:10.1093/sleep/zsab072.480