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.