Enemem, Ampakine's effect on sleep architecture in the Sleep Dep trial (as measured by EEG polysomnography) was seen at the *highest doses* (they used 100 mg, 300 mg, and 1000 mg) -- >>> "CX717 produced some stimulant activity at the highest doses and seemed to interfere with deep sleep and the ability to fall asleep in a dose-dependent manner." <<<
So when dosing at 1000 mg or more, CX-717 will likely produce some insomnia. Additional insights can be gleaned from the ADHD trial, which dosed up to 800 mg twice/day, with 34% of patients at the high dose having insomnia (compared to 13% of patients on placebo).
But how high would dosing need to be to treat Sleep Apnea? Using RD as a guide, while we went up as high as 2100 mg in RD-2, and 1500 mg was used in RD-1, it was later revealed that the 900 mg cohort in RD-2 worked just as well as the 1500 mg dose in RD-1 (as measured by improvement in VE-55, see slide 8 from 11-10-08). However, even if the ideal therapeutic dose in RD turned out to be only 900 mg, and assuming RD is an accurate guide for extrapolating dosing for Apnea, and CX-1739 has similar insomnia-inducing ability as CX-717, we're still probably looking at a fair amount of insomnia side effect potential in our CX-1739 SA trial.
But there are other unknown variables too, which may outweigh all other factors. For example -- will the enhancement of sleep quality due to the improvement in apnea symptoms far outweigh any sleep interference due to the Ampakine?
Well, the only way to find out is to run the trial and see what happens. It'll be exciting to see these results.
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