“Use new drugs early before they lose their effectiveness.”  This old adage of medical epidemiologists may soon need be replaced by “use new drugs early before we discover their major side effects.”  Whether it’s vioxx or celebrex, pemoline or ambien, we are finding out that short term FDA required trials don’t tell the whole story about any new drug or medical device. The recent scare about sleeping pills shows how American medical care truly works:  how increasingly stressed American workers especially working mothers, aggressive drug marketing, lax Federal regulation, and doctors’ response to financial incentives can lead to the next “health crisis.”  Until the country realizes the goal is public health rather than patchwork attempts at medical reform, expect more health crises.

Sleeping Pills

         Once a medication is approved by the FDA, it takes a lot for that agency to notice something went wrong.  Generally, two types of negative results  attract FDA attention: death, particularly from a rare cause or disease, or something bizarre, especially bizarre behavior.

         The new sleeping pills, like ambien and lunesta, have now fulfilled the bizarre behavior criterion for FDA action.  People taking lunesta and ambien can be found driving down the highway, painting their front doors, having sex with strange partners, waking up with empty cartons of sour cream in their beds and very white tongues – all without recollection of what went on.

         Were these people  asleep?  From a pure biological standpoint, no.

         Most people think that sleep and wake are thoroughly separate, entirely different states.  The truth, as in most complex biosystems, is far more complex.   To go from wake to sleep, many different parts of the brain must to coordinate huge shifts in synchronized activities.  Sometimes when people take sleeping pills, they don’t make the leap. They end up in what some researchers call in-between states, neither awake nor asleep.  In these state, lots of weird things happen.  Even when people with sleeping pills “sleep,” their sleep is usually different from normal, non-pharmaceutically induced sleep.

Use Only As Directed

         A major cause of these in-between sleep and wake states is concomitant use of sedative-hypnotic drugs and other drugs, particularly alcohol.

         Any sleep clinician might tell you that’s no surprise.  About 5% of the population uses alcohol as a knock-out pill.  Many have “discovered” adding a sleeping pill to booze “really works” in putting them to sleep.

         Most of the public doesn’t know that alcohol markedly disrupts sleep continuity.  Or that alcohol’s effect at midnight is about two to three times more potent than at 6 P.M.  Lack of such knowledge has traditionally helped people become addicted to alcohol, the age-old sleeping pill.

         Equating pills with sleep (Pill=Sleep) is a common way people become addicted to sleep aids.   The pharmaceutical companies can and often say such behavior is not their fault.  Pharmaceutical company legal departments are very active places.  It is standard for the companies to say that all pills should be utilized “only as directed.”

         Except people don’t do that.  Despite public disclaimers, pharmaceutical companies are very aware that people do not follow doctor’s suggestions, let alone the recommendations in the Physicians’ Desk Reference.  If you ever listen to a drug-company lecture  you will probably hear that the majority of the patient population does not take their pills, whether it’s aspirin or steroids, as directed.  The drug companies may possess a legal out, but the damage to public health continues.

         Next week, in Part II: Proposals to fix the problem.

Dr. Matthew Edlund, M.D., M.O.H., director of The Center for Circadian Medicine, is an expert on applied public health, sleep medicine and psychiatry. A former professor at Brown and University of Texas medical schools, he can be reached via email to DocME@DoctorEdlund.com. And CLICK HERE to subscribe to our new Fitcast, via the iTunes Store.