In a major set back for Merck, FDA has turned down a sleeping pill that Wall Street thinks will someday generate over $700 million in sales each year. FDA also stated its concern that the drug can cause you to be sleepy the next day and can even impair driving. After going over the letter, Merck noted that more clinical trials on the 10 mg dose is not needed. According to an industry analyst, forcing Merck to use lower doses and turning down the higher doses due to safety concerns, means that suvorexant will have rather mixed prospects in the market.
FDA seems to be saying that it sees a safety issue with the sleeping pill, so it is going to make it a harder sell in the market, which already has a good deal of choice in this therapeutic area. Merck offered that most adults would begin at the 20 mg dose and boost it to 40 mg as needed.
FDA also noted that the dose of 10 mg should be where to start for the majority of patients, and should be made available before the drug can get approval. Merck stated that it will talk with FDA on whether more studies are needed to support a dose of 5 mg. Merck states that the lower dose is not effective and is pushing for FDA to approve the higher doses.
For older people, Merck said that they should start at 15 mg and then increase to 30 mg if needed.

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