Sleep medicine specialists, psychiatrists, neurologists, ENTs, and PCPs should be able to define the FDA drug approval regulations surrounding “tentative approval” status after completing this 0.25-credit, 15-minute educational CME activity. They should also be able to describe the clinical outcomes from the pivotal trials of once-nightly sodium oxybate demonstrating its safety and efficacy and identify the “non-drug” issues that are the cause of the FDA’s delay in approving the once-nightly medication for insomnia.
