FDA Issues Safety Warning on Lunesta
In mid-May of 2014, the FDA released a warning that eszopiclone (Lunesta) can cause next-day impairment when taken at the recommended target dose of 3 mg/ day. As a result, the FDA has lowered the recommended starting dose to 1 mg/day.
The FDA cites a double blind, placebo controlled study of 91 adults that found working memory and the psychomotor coordination required to drive a car were impaired for up to 11.5 hours after a 3 mg bedtime dose of Lunesta.
They also determined that subjective perception of sedation and coordination—in other words, patients’ abilities to realize they were sleepy or impaired—were no different than placebo, although these patients were actually quite impaired. Women and men were equally affected.
In fact, according to the data summary from the FDA, a 3-mg dose of Lunesta was almost as impairing as 7.5 mg zopiclone, a medication often used as a positive control in studies of driving impairment (and, interestingly, the parent compound of Lunesta).
Doses can be titrated up to 3 mg from the new starting dose of 1 mg, says the FDA, but patients taking the 3 mg dose are cautioned against driving and related activities the next day. Read the warning.
Move Over Ketamine? New Fast-Acting Antidepressant Shows Promise
A new drug is showing rapid, long-lasting results in early rodent studies, according to a paper presented by Jeffrey Talbot of Roseman University of Health Sciences at the annual meeting of the Federation of American Societies of Experimental Biology (FASEB) in April 2014.
The drug, Ro-25-6981 (nicknamed “MI-4”) has been shown to reduce depressive symptoms almost immediately, similar to ketamine. However, unlike the ketamine data thus far, this new study shows that those effects can be maintained for about three weeks, says Dr. Roseman.
The medication has a unique mechanism of action according to an April article on the website Science Daily. While working as an NMDA antagonist and stimulator of neurogenesis (at least in vitro), MI-4 also works through triple reuptake inhibition to increase levels of dopamine, norepinephrine, and serotonin.
Triple reuptake inhibitors are also known as serotonin–norepinephrine–dopamine reuptake inhibitors (SNDRIs). Amitifadine, a SNDRI developed by Euthymics Bioscience has shown positive results in clinical trials. The SNDRI liafensine was dropped by Bristol-Myers Squibb in phase IIb trials when it failed to perform better than Cymbalta. Dr. Roseman’s research will be published later in 2014.