New sleeping pill poised to hit US markets

May 21, 2013

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.

Explore further: FDA has safety concerns on Merck insomnia drug

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 while performing ...

FDA reviewing Merck's experimental insomnia drug

November 8, 2012
(AP)—Drugmaker Merck & Co. says the Food and Drug Administration is reviewing its experimental insomnia medication, suvorexant (SOO'vor-eks-ant).

FDA requires lower doses for sleep medications (Update)

January 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 more safety ...

Is a better sleeping pill on the way?

April 3, 2013
(HealthDay)—A new class of sleep medications appears to help people fall asleep without causing grogginess the next day, researchers say.

Merck says FDA reviewing its ragweed allergy therapy

May 8, 2013
Drugmaker Merck & Co. says the Food and Drug Administration is reviewing its second application to sell a new type of allergy treatment meant to gradually reduce allergic reactions over time, rather than just relieving sneezing, ...

Recommended for you

In most surgery patients, length of opioid prescription, number of refills spell highest risk for misuse

January 17, 2018
The possible link between physicians' opioid prescription patterns and subsequent abuse has occupied the attention of a nation in the throes of an opioid crisis looking for ways to stem what experts have dubbed an epidemic. ...

Patients receive most opioids at the doctor's office, not the ER

January 16, 2018
Around the country, state legislatures and hospitals have tightened emergency room prescribing guidelines for opioids to curb the addiction epidemic, but a new USC study shows that approach diverts attention from the main ...

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.