Tuesday, February 3, 2015

Suvorexant -- Branded As Belsomra®, Finally Clears DEA/FDA -- Low Starting Doses Only

It enters a crowded field, and does so as a Schedule IV psychoactive agent (read: lots of extra record keeping, and lock up precautions -- at the dispensing point). I'm not sure it will ever reach $500 million in sales. We shall see.

Even so, it is good news, for Kenilworth:

. . . .The recommended dose of BELSOMRA is 10 mg, taken no more than once per night and within 30 minutes of going to bed, with at least 7 hours remaining before the planned time of awakening. The total dose should not exceed 20 mg once daily.

BELSOMRA is contraindicated in patients with narcolepsy. BELSOMRA contains suvorexant, a Schedule IV controlled substance. BELSOMRA can impair daytime wakefulness. Central nervous system (CNS) depressant effects can last for up to several days after discontinuation. . . .

At the FDA Advisory Committee around last Valentine's Day, there was great concern about the heavier doses. . . so it enters with a low initial dose, which makes it only slightly different, in most prescribers' minds, I think -- than all the other sleep prescriptions already on market. But I could be wrong. In fact, I hope I am. [Here's more background on this oft' delayed US launch.] Onward, out into the . . . snow.

No comments: