FDA panel backs Merck insomnia drug, but warns of safety concerns

sleeping merck (AXO-365)

An FDA panel might have given its backing to Merck's insomnia drug suvorexant, but this may not signal the end for the pharmaceutical giant's sleepless nights. The US Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee has recommended Merck's suvorexant when given in low dosages, but the panel rejected the drug in higher doses due to potential drug safety concerns (PharmaTimes).

Insomnia affects up to 30% of the adult population, and the FDA note that despite the availability of a number of treatments, the condition still remains a significant medical problem. Suvorexant (MK-4305) is the first in a new class of medicines called orexin receptor antagonists, and is said to provide improved sleep onset as well as maintenance of sleep through the night. Indeed, the FDA weren't concerned with the effectiveness of the drug, with the committee voting 12-4 and 16-0 that the drug works in inducing and maintaining sleep, voting 13-3 that suvorexant was safe for elderly patients at 15mg a day and for non-elderly patients at 20mg a day. However, FDA staff said that higher doses of the drug could induce daytime drowsiness, elevated cholesterol and suicidal thinking, and voted 8-7 that the drug was unsafe when given to elderly patients at 30mg or non-elderly patients at 40mg.

In their report, the FDA panel wrote that there was "little to no dose-response for effectiveness across the range of doses tested (10mg-80mg)" but that there is a "dose-response for significant adverse reactions, including, for example, impaired driving and suicidal ideation".

What do you think? Do you think the restriction to lower doses will have an effect on Merck's ability to market the drug? Why not join our discussion on LinkedIn, or leave a comment below.

If you want to know more about drug safety and addressing the key challenges for safety professionals, you might be interested in attending the World Drug Safety Congress Europe 2013, 10-12 September 2013, London.

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