About 9 million, or 1 in every 25 Americans, take prescription sleep medication, spending $41 billion on sleep aids in 2015. The industry is supposed to reach $52 billion by 2020. Typical sleep meds, including Ambien and Lunesta, work by targeting neurotransmitters, the chemical signalers in the brain, either by enhancing the effects of calming neurotransmitters or diminishing the effects of those involved in arousal.
Although they are effective for many people, others, especially people with more intractable disorders such as insomnia and DSPD, don't respond as well or at all to prescription sleep medications, which also tend to have a high propensity for addiction. Only a couple of companies — pharmaceutical giant Merck and a small biotechnology start-up called Reset Therapeutics — are currently exploring potential therapeutic compounds that target the genes controlling the biological clock.
More from Modern Medicine:
To live longer, don't just eat less — eat less often
The link between sugar and cancer is uncovered
Tech addition sweeps across US
Rather than producing sleep medications, however, both companies are primarily focused on developing medications for the serious, secondary diseases associated with disordered sleep. "The same mechanism that drives circadian rhythm those rhythms exists in pretty much every cell in your body," explained Ross Bersot, president and CEO of Reset Therapeutics, based in San Francisco, which has developed drug compounds aimed at treating diabetes, non alcoholic fatty liver disease, hepatitis and other metabolic disorders by targeting CRY1 and other genes that control the sleep/wake cycle.
"CRY1 has roles outside the circadian clock," Patke said.
When we go to sleep and when we wake up has a cascading effect on the rest of the body's clocks, altering hormone levels throughout the day and impacting when the liver starts secreting certain enzymes, which affects the timing of when we get hungry, as well as glucose tolerance, insulin sensitivity and other factors that can contribute to the development of disease.
"There are clocks in every organ and every tissue in your body, but they aren't in the same phase. In a body synchronized the way it should be, it could be New York time in brain, Paris time in liver and Beijing time in lungs," Patke said.
Reset Therapeutics is now halfway through stage one of clinical testing to determine drug safety in humans. In earlier animal studies, molecular compounds designed to delay protein degradation were found to reduce insulin resistance in mice, as well as restore regular body temperature, which goes out of whack in diabetes.
Reset's strategy is based on research by Joseph S. Takahashi, head of the neuroscience department at University of Texas Southwestern Medical Center, and another pioneer in the field of circadian genetics who serves on Reset's Advisory Board.
Even if all goes well (which it often doesn't in clinical trials), however, the company is still years away from FDA approval and bringing a drug to market. Reset Therapeutics is also developing an is Apart from an insomnia medication targeting biological clock genes other than CRY1, which is in an earlier phase of testing.