Merck Insomnia Drug Rejected by FDA, Lower Dose Version May Receive Approval

Health officials rejected Merck & Co's new insomnia drug application but opened the door to approval to a new lower-dose version of the medication, according to a statement the company made Monday.

The U.S. Food and Drug Administration said Merck received a complete response letter that the agency may consider a 10 milligram starting dose of suvorexant for most patients.

The company proposed that elderly patients start by taking 15 mg of the drug and increase that to 30 if necessary. However, non-elderly adults can begin at a higher level-such as 20 mg with a gradual increase to 40 mg if needed. However, as of Monday, the FDA wrote that doses of 30 mg and 40 mg were not safe for approval.

"We will evaluate the requests outlined in the Complete Response Letter and expect thereafter to work expeditiously with the FDA to make suvorexant available as a new treatment option for patients suffering from insomnia," Roger M. Perlmutter M.D. Ph.D. president Merck Research Laboratories, said in a news release.

Though the company is not going to do additional clinical research studies of suvorexant at 10 mg doeses, they will start manufacturing studies to advance the same dosage form. The global health care leader will discuss with the FDA whether additional studies for other dosages will be required to support the 5 mg dose of the insomnia medication.

"If approved suvorexant would be the first in a new class of medicines called orexin receptor antagonists for use in patients with insomnia...Merck researchers developed suvorexant to facilitate sleep by blocking the action of orexins which are neurotransmitters in the brain that help to keep a person awake," Merck said.

To see the original release, click here.