Despite the successful use of Ambien and other sedative-hypnotics and anti-anxiety medications, there remains significant problems. First, many people take these pills because they are afraid of waking up in the middle of the night, by which time it would be too late to take a pill and not be groggy the following morning. Many of my patients report grogginess if they take the meds too late at night. For this reason many of my patients feel compelled to take their pills much earlier, and I suspect this leads to overuse—treating the fear of insomnia, rather than insomnia itself.
Now along comes Neurocrine Bioscience's new insomnia treatment, Indiplon. The FDA issued an approvable letter for the drug last month. A study published last month in the journal Sleep reports this drug to be safe and that it “resulted in significant and sustained improvement in both the ability to return to sleep and the amount of sleep obtained in the remaining time left in bed, following a nocturnal awakening.”
Not only that, but Indiplon showed no evidence, according to the study patients, of next-day side effects. It also was used less than four times per week in the study, as patients held off using it unless they really needed it. As a matter of fact, 40-80% of insomniacs report that their symptoms don't occur every night.
Longer-term studies still need to be done, but hopefully this drug will be headed back to the FDA for approval and, eventually, clinical use. And for those of us bleary-eyed, overworked worriers who are afraid to use sleeping pills unless we absolutely need them, this approval won't come a moment too soon.
Marc Siegel, MD, is an internist and associate professor of medicine at New York University and the author of False Alarm: The Truth About the Epidemic of Fear