Merck Insomnia Drug Safe Only in Lower Doses, Panel Says

Merck & Co. (MRK)’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.

The treatment is designed to turn off wakefulness rather than subdue the brain into slumber like branded and generic versions of Ambien and Dainippon Sumitomo Pharma (4506) Co.’s Lunesta, the most widely used insomnia medications. FDA staff said earlier this week they were concerned about severe residual daytime side effects of Merck’s drug that could lead to driving while impaired and suicidal thoughts, especially at high doses. Read full article at Bloomberg...

Author of the article: 
Anna Edney