Even the successful sleep aids have come under scrutiny in recent months by the FDA. In a ruling earlier this year, the FDA required sleep disorder drugmakers that develop drugs containing the active ingredient zolpidem, such as Sanofi SA (ADR) (NYSE:SNY)‘s top-selling Ambien, to cut their recommended dosage in half. This comes on the heels of numerous reports of auto accidents caused by an impairment of the sleep aid the following day. Although this move shouldn’t affect Ambien sales, or sales of other sleep aids using the active ingredient zolpidem in theory, it’s a visible knock against their safety over the short term.
Do insomniacs have any hope?
If you’ve been wondering whether insomniacs have any hope left, it just may come in the form of Merck & Co., Inc. (NYSE:MRK)‘s experimental drug suvorexant. Last month suvorexant went before the FDA’s panel and received a generally positive review of 12 to 4 that it was effective in maintaining sleep for patients. However, like Ambien, the FDA did echo one bit of concern about suvorexant’s dosing, noting that 11% of the nearly 1,300 subjects who took higher doses of the sleep aid in trials exhibited somnolence (essentially a state of near-sleep). At lower doses, somnolence was reduced to just 7%.
With peak sales estimated at approximately $700 million in a $2 billion industry, suvorexant has a shot at being a dominant treatment — assuming it is eventually approved and doesn’t stumble off out of the gate.
While history is certainly not on the side of sleep-aids drugmakers, I feel that the progress of suvorexant is worth keeping a close eye on. I believe the big key to its success will be whether insurers latch onto the treatment en masse, ultimately reducing user co-pays and out-of-pocket costs. In the meantime, though, it looks like the waiting game will continue for insomnia suffers looking for new treatment options.
The article Can’t Sleep? Don’t Worry, You’re Not Alone originally appeared on Fool.com and is written by Sean Williams.
Fool contributor Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.The Motley Fool recommends Procter & Gamble.
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