ARTICLE | Regulation
Suvorexant safety
Why FDA might back lower starting dose of Merck's suvorexant for insomnia
June 3, 2013 7:00 AM UTC
An FDA advisory committee vote may help senior officials in the Division of Neurology Products resolve a disagreement among review staff about the approvability of insomnia candidate suvorexant from Merck & Co. Inc.
The reviewers agreed suvorexant is effective. But in briefing documents prepared for the May 22 meeting, FDA's clinical reviewer concluded the risks of next-day somnolence were comparable to those of approved insomnia drugs, and that risks of driving impairment associated with the lowest doses tested in Phase III - 15 mg in elderly patients and 20 mg in others - could be mitigated with labeling...