New Insomnia Drug Gets Closer To FDA Approval
An experimental insomnia drug has advanced closer to U.S. approval this week after facing scrutiny by the U.S. Food and Drug Administration. The FDA convened a panel of medical experts to review the drug suvorexant, which could be the first of a new form of insomnia medication that blocks brain chemicals called orexins which keep people awake. The drug intends to help people fall asleep and stay asleep throughout the night.
On Monday, the FDA’s internal reviewers expressed concern about suvorexant’s potential to cause next-day drowsiness and impaired driving. As reported by the Huffington Post, the internal reviewers asked to consider whether starting patients at a lower dose than initially recommended by Merck and Co., the creators of the drug.
Merck originally proposed elderly patients be started at 15 milligrams of suvorexant, and increased to 30 if needed, while non-elderly adults were recommended to start at 20 milligrams, which would be doubled if necessary. The FDA opined otherwise, stating they didn’t believe there was any evidence the higher dosages we effective or safe. Specifically, they highlighted the increased risk for suicidal thoughts and behaviors, impaired driving, and severe sleep disturbances at the increased dosages.