My hope springs eternal when it comes to the possibility of a better sleeping pill. Suvorexant, Merck’s new insomnia drug, is currently under review at the FDA, and I’m wondering whether this will be it.
Suvorexant is a different from sleeping pills like Ambien (a.k.a. zolpidem) and Lunesta. These older pills work by enhancing the activity of GABA, the main neurotransmitter that shuts the brain down at night.
Suvorexant works on a different system—the orexin system. Neurons that produce orexin fire rapidly when we’re awake. The new sleeping pill works by temporarily blocking the action of orexin, thus facilitating sleep. So unlike like the Ambien clones approved in recent years (Edluar and Zolpimist, for example), suvorexant is a truly novel drug.
Efficacy and Safety
But my hopes for any new sleep med are never too high. Many sleeping pills go up for review by the FDA only to receive a thumbs-down, and not because they’re ineffective. To gain FDA approval on measures of efficacy, a new drug only has to work better than placebo.
It’s the safety standards that are so hard to meet, especially in a climate like this one, where Ambien has recently emerged as a culprit in traffic accidents and rising numbers of visits to the emergency room. To develop an insomnia drug that knocks people out at night but then wakes them up in the morning appears to be about as easy as winning a Pulitzer.
So I wasn’t surprised to learn on Wednesday that, while a panel of experts voted to endorse the efficacy of suvorexant, they had serious reservations about its safety at higher doses. They deemed the 10 mg dose, the lowest dose tested by Merck (and also the least efficacious), safe. But enough subjects taking higher doses suffered grogginess in the morning, impaired driving, thoughts of suicide, and “narcolepsy-like” symptoms, that a majority of the experts voted against approving doses of 15 to 40 mg. (Read the full story by FierceBiotech here.)
The FDA is not bound by these expert recommendations. But it will consider them as it completes its review of suvorexant, which should, according to Merck, be issued by the middle of the year.
Me, I’m not going to predict how the FDA will decide this one, or whether, if approved, the 10 mg dose of suvorexant will be a balm for what ails me. Safe but ineffective, or effective but unsafe: new sleeping pill, same caveats.
Would you consider trying this drug if it comes on the market? Why or why not?