New sleeping pill poised to hit US markets

An experimental sleeping pill from US drug company Merck is effective at helping people fall and stay asleep, according to reviewers at the US Food and Drug Administration, which could soon approve the new drug.

But the experts warned of dangerous side effects at high doses—including residual sleepiness during the day and, in a small number of subjects, —according to their report posted Tuesday.

The FDA has convened a group of independent experts for Wednesday to make recommendations to the agency on whether to authorize the medication for the US market.

The FDA is not required to follow the recommendations of the panel, but generally does so.

The drug, Suvorexant, also known as MK-4305, is a new class of sleeping pill, which works by blocking "-promoting orexin neurons" from working, thus helping the body transition to sleep.

Merck has proposed a dose of 15 milligrams for people over 65 and 20 milligrams for those under 65, with doses up to twice as high recommended for those whose symptoms persist.

But the FDA noted clinical trials indicated a dose of just 10 milligrams was safe and effective, and it planned to ask the independent panel to consider recommending all patients start with this smaller dose and whether it should ask Merck to study if doses under 10 milligrams might also be effective.

In January, the FDA asked the pharmaceutical companies behind Ambien and other similar sleep aids to reduce their recommended dosages after studies showed an increased risk of and related car accidents.

The FDA notably required the companies to cut by half the recommended doses for some for women—whose bodies apparently metabolize the drugs more slowly.

Insomnia affects up to 30 percent of US adults, the FDA said.

According to analysts, Suvorexant could generate for Merck some $650 million in sales by 2018.

add to favorites email to friend print save as pdf

Related Stories

FDA has safety concerns on Merck insomnia drug

May 20, 2013

Federal health regulators say an experimental insomnia drug from Merck can help patients fall asleep, but it also carries worrisome side effects, including daytime drowsiness and suicidal thinking.

FDA: lower ambien's dose to prevent drowsy driving

May 15, 2013

(HealthDay)—The U.S. Food and Drug Administration has approved new, lower-dose labeling for the popular sleep drug Ambien (zolpidem) in an effort to cut down on daytime drowsiness that could be a hazard ...

FDA requires lower doses for sleep medications (Update)

Jan 10, 2013

(HealthDay)—The U.S. Food and Drug Administration announced Thursday that it is asking manufacturers of sleep medications containing zolpidem—including Ambien—to lower the recommended doses and to provide ...

Is a better sleeping pill on the way?

Apr 03, 2013

(HealthDay)—A new class of sleep medications appears to help people fall asleep without causing grogginess the next day, researchers say.

Recommended for you

Novartis Japan admits concealing drug side effects

22 hours ago

The Japanese unit of Swiss pharma giant Novartis has admitted it did not report more than 2,500 cases of serious side effects in patients using its leukaemia and other cancer drugs, reportedly including some fatalities.

Most US babies get their vaccines, CDC says

Aug 28, 2014

(HealthDay)—The vast majority of American babies are getting the vaccines they need to protect them from serious illnesses, federal health officials said Thursday.

Expression of privilege in vaccine refusal

Aug 27, 2014

Not all students returning to school this month will be up to date on their vaccinations. A new study conducted by Jennifer Reich, a researcher at the University of Colorado Denver, shows that the reasons why children may ...

User comments