New/Emerging Sleep Drugs

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The wish list for insomniacs and doctors includes a drug that will help with sleep maintenance insomnia. The most prescribed hypnotics generally work better at addressing sleep on-set than sleep maintenance.

The trend in new insomnia drugs seems to be away from activating the GABA neurotransmitter system and toward working through more subtle endogenous neurological pathways involved in the sleep-wake cycle.

The pharmaceutical companies – the big ones – make money largely if they can get a patent on a drug. A large part of the business models of the biggest companies, and some small ones, is upfront investment in drug development and, if they can bring new drugs to market, to charge high prices for them. It’s what business analysts call a high-operating leverage business.

This leads to development of follow-on drugs – medicines that are chemically and bioactively similar to other drugs, but different enough to qualify for patent protection. Occasionally an entirely new class of drugs is developed (discovered) and that is truly exciting if the drugs are efficacious (that is, if they work)

New insomnia drugs could fall into existing classes

The Chinese company Jingxin Pharmaceutical Co. developed a drug called EVT 201, which has been in Phase II trials. It is being developed for possible commercial use outside China by the German company Evotec. Evotec’s website shows the next step is Phase IIb trials. EVT 201 is a GABA agonist, so we put in the category with the Z drugs.

The large drug company Merck is pursuing the orexin neurotransmitter route. Their compound suvorexant acts as an antagonist to both OX1 and OX2 receptors. It was approved by the FDA in 2014 and hit the market in 2015.

Merck was developing a couple of other orexin antagonists called MK-6096 and MK-3697 and took them to clinical trials. But there are no recent references to these molecules on Merck’s website. We assume the company has stopped development.

Merck was developing a couple of other orexin antagonists called MK-6096 and MK-3697 and took them to clinical trials. But there are no recent references to these molecules on Merck’s website. We assume the company has stopped development.

The GABA agonist drugs indiplon and gaboxadol both washed out in the clinical trial process and are on the list of biggest disappointments in sleep medicine in recent years.

5HT2A antagonists for insomnia developed for insomnia includes Volinanserin, Eplivanserin and Nelotanserin all of which have been abandoned by their makers after not performing well in clinical trials.

Looking at whether the pharmaceutical companies drug developmentare continuing development is the best way to see the potential of new insomnia medications. An excellent webpage for keeping tabs on medicines in development is http://www.neurotransmitter.net/newdrugs.html – scroll down to the section on Treatments for Sleep Disorders. It is well established that there is a bias in scientific publication where good news and positive results get more play than others. Looking at the efficacy and safety of insomnia medicines, Dutch researchers found “positive trials were approximately two times more likely to be published.”

Process of Approval

When a regulatory agency such as the US Food and Drug Administration looks at a new medicine to consider whether it should be approved for sale and distribution, they consider the quality and quantity of evidence. Randomized clinical trials, the most compelling evidence, are almost always submitted by the manufacturer, who spends a lot of time and money conducting the trials.

More personalized treatment

One problem or opportunity, depending how you look at it, is that new hypnotics may not be appropriate for all or even most people with insomnia. It is possible that in the future there will be more precision in targeting specific subtypes of insomnia, which will require better diagnosis of sleep disorders. Melatonin agonists and orexin antagonists also require greater attention to the time of day when the patient takes the medicine, as they work more in alignment with natural circadian system.

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