Chapter 9
Needs For Hypnotics Research

For those drugs I listed as Sleeping Pills Associated with Significant Mortality Risk (in Chapter 1), evidence shows those pills are too risky ever to be used (except for end-of-life and hospice care). Unfortunately, the magnitudes of the risks have not been measured with sufficient accuracy. Even less is known about drugs currently being used as sleeping pills for which too little was known to list the risk. More research is needed to learn if there are any of the sleeping pills that are safe and effective enough to be used.

For potential substitute drugs such as trazodone, doxepin, suvorexant and melatonin, we do not have electronic records studies equivalent to those for the drugs I listed as having significant mortality risk, nor for the still-newer drugs in the development pipeline. Perhaps electronic records studies of the current substitute drugs will eventually reflect on any possible association with mortality and cancer. Nevertheless, for any sleeping pill kept in use or for any newer drug, we ought to have and should demand long-term controlled trials of sufficient size to confirm if the drugs do or do not cause excess mortality, cancer, depression, infection, and other serious harms.

There must be quite a few billionaires who have seen family members develop cancer or die after taking sleeping pills. One would think that charitable donors would want better information about when sleeping pills are safe and whether any sleeping pills are worth the risks. A few tens of millions of dollars donated to universities or private foundations could advance medical research about sleeping pill safety a long way.

As mentioned, I petitioned the FDA to require long-term risk studies under The FDA Amendments Act of 2007, but the FDA has effectively refused by delaying any action beyond the reasonable deadline I requested for completion of such urgent studies. If we want such studies, somebody else will have to pay for them. Meanwhile, it is time to stop using those medicines without waiting for studies that the FDA and manufacturers obviously have no intention of performing. There is plenty of evidence already now that those medications are too risky.

Lack of government curiosity about sleeping pill prescribing is exceptional. As mentioned above, government agencies denied that they had data on overall U.S. consumption of sleeping pills. The U.S. government has certainly been more careful in studying other addicting drugs.

In fairness, let me mention that the same heavy prescribing of hypnotics existed in Communist countries before the dissolution of the Soviet Union, and there was a similar lack of studies behind the Iron Curtain. One should not ascribe the scientific neglect of sleeping pills entirely to the profit motive. There are just too many people all over the world who haven’t enough sense to be cautious of a Candy Man.