Merck Insomnia Drug Safe Only in Lower Doses, Panel Says

Merck & Co.’s experimental insomnia drug, meant to be a less disruptive alternative to Sanofi’s Ambien sleeping pill, is safe only at lower doses, U.S. regulatory advisers said.

Merck is seeking Food and Drug Administration approval to sell the treatment, suvorexant, in two dose ranges. The lowest doses of 15 milligrams to 20 milligrams are safe, a panel of advisers to the FDA voted 13-3 yesterday at a meeting in Silver Spring, Maryland. The highest doses of 30 milligrams to 40 milligrams aren’t safe, the panel said in an 8-7 vote.