The FDA put out a warning this month regarding the insomnia drug Lunesta (eszopiclone). The warning was that the drug could cause next day impairment of driving, memory, and coordination. It was based on the results of a 91 person placebo-controlled study in which participants taking the medication at 3 mg showed significant impairment of psychomotor and memory function up to 11.5 hours later. Even more alarming was the fact that the majority of these people were unaware that they were impaired. As a result, the FDA has asked that the starting dose of 2 mg be reduced to 1 mg. In those already taking higher doses, the FDA advised that they continue taking their prescribed dose but contact their healthcare providers to ask about the best dosage for them.
This really comes as no surprise to those of us in sleep medicine. In August 2013, the FDA issued a similar warning about Ambien (zolpidem). The difference was the Ambien warning applied more to women than to men. The present study, and thus the warning, found both men and women equally impaired and unaware. What these medications have in common is that they both work on what are called GABA (gamma-aminobutyric acid) receptors in the brain. GABA is one of the most potent inhibitors of neuronal function that exists. The problem is that in addition to promoting sleep, these receptors, when activated, also can impair memory, balance, and complex tasks such as driving. In the case of Lunesta, earlier studies had already demonstrated that it was less specific for sleep-related brain sites than Ambien. The problem with both of these medications is that at previously accepted doses they appear to linger much longer than was earlier appreciated. Even more alarming is the individual is frequently unaware of this impairment. It makes me wonder just how many early morning fender benders may be due to these medications.
As a sleep specialist, I have found myself prescribing less and less prescription sleep aids. This has especially been the case with the benzodiazepine type medications such as Ambien, Lunesta, Restoril, and Ativan to name a few of the more popular, all of which exert their effects by acting on the GABA receptor.
So what is a person with insomnia to do? I believe the first approach lies in good sleep hygiene. Establish a set sleep-wake schedule; turn off computers, televisions, and iPads. Make sure your bedroom is quiet and at a comfortable temperature, thus conducive to sleep. Second, your bedroom should be for sleep and sexual activity only–it is not the place to do your work or ruminate on the day’s problems.
Finally, there are those with insomnia that truly have a problem with physiological hyperarousal. They produce too much cortisol and other stress hormones at night. For some, diet and exercise or judicious use of supplements such as melatonin might work. However, that still leaves others for whom none of this gives them that much-needed minimum of seven hours sleep. In that case, if you are on one of these GABA-type medications, discuss the possibility of either lowering the dose or changing to an alternative medication that works in a different manner. I can tell you there are some good alternatives out there with more in the developmental stage.