Experts favor US approval of Merck sleeping pill (Update)

May 22, 2013 by Kerry Sheridan

An independent panel of experts on Wednesday recommended US approval of a new Merck sleeping pill called suvorexant, but expressed concerns over the highest dosage and risks of drowsy daytime driving.

A majority of the panel voted that the drug was safe and effective in most cases, but experts were divided on the question of approving the safety of higher doses if lower doses did not appear to work for patients.

The panel voted 13 yes, three no with one abstention that starting doses of 15 and 20 milligrams were adequately safe.

But the members were narrowly against the question of whether doses up to 30 and 40 mg would be safe and acceptable—seven voted it was safe while eight said it was not, and two abstained.

The Food and Drug Administration is not required to follow the advice of the independent panel but it usually does.

The drug works differently than the top sleeping aid on the market at present, Sanofi's Ambien, or zolpidem, which boosts neurotransmitters known as GABA receptors.

Merck said suvorexant blocks "wakefulness-promoting orexin neurons" from working. If approved, it would be the first time the chemical is released on the US market.

FDA doctors who reviewed the research on the drug ahead of the panel meeting said it appeared effective but not safe at the higher doses studied.

For adults under age 65, the doses ranged from 20 to 40 mg. For those over 65, the doses studied were 15-30 mg.

The independent panel debated the findings all day, with one of the main topics being whether a lower dose of 10 mg would be safe, effective and avoid risks such as dangerous driving from persistent sleepiness.

Merck's representative said the response from a 10 mg dose would be "quite small and not very different from the placebo response."

However, FDA reviewers believed the lesser amount would likely work, leading one doctor on the panel to remark that he felt he was in an episode of the "Twilight Zone," where the government was saying a drug would work while the pill's maker disagreed.

The drug has a half life of 12 hours, meaning it remains in the system long after waking. It is also metabolized much more slowly by overweight women than by normal weight men.

Up to two percent of patients studied reported daytime drowsiness. Among those taking the highest doses, six percent reported that such episodes were severe.

FDA reviewers found that "suvorexant can cause significant impairment in driving the morning after dosing."

Also, eight of 1,268 suvorexant patients had suicidal thoughts in a 12-month study, compared to zero in a placebo group of just over 1,000 people.

The drug is not to be taken in combination with antidepressants, stimulants, and blood thinners.

When asked if further studies should be done to determine if a lower dose of 10 milligrams would be safe and effective a majority of the panel voted no.

"We are excited about the potential of suvorexant as a new and different approach to treating insomnia," said Darryle Schoepp, senior vice president and head of Neuroscience and Ophthalmology, Merck Research Laboratories.

"Today's votes and discussion bring us one step closer to providing physicians with another option to help patients struggling with insomnia."

Between 30 and 40 percent of US adults say they suffer insomnia symptoms at least once in a given year, and 10-15 percent report chronic insomnia, according to the National Center for Sleep Disorders Research at the National Institutes of Health.

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.

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.

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).

Suvorexant drug may offer new approach to treating insomnia

November 28, 2012
A new drug may bring help for people with insomnia, according to a study published in the November 28, 2012, online issue of Neurology, the medical journal of the American Academy of Neurology.

US panel backs inhaler drug for lung disease

April 17, 2013
A panel of U.S. respiratory experts voted Wednesday in favor of approving an experimental inhaler drug from GlaxoSmithKline and Theravance for treating chronic lung disease.

FDA panel backs long-acting Boehringer inhaler

January 29, 2013
(AP)—A panel of federal health experts is overwhelmingly recommending approval for a long-acting inhaler to treat people suffering from chronic lung disease.

Recommended for you

Mind-body therapies immediately reduce unmanageable pain in hospital patients

July 25, 2017
Mindfulness training and hypnotic suggestion significantly reduced acute pain experienced by hospital patients, according to a new study published in the Journal of General Internal Medicine.

Study suggests ending opioid epidemic will take years

July 20, 2017
The question of how to stem the nation's opioid epidemic now has a major detailed response. A new study chaired by University of Virginia School of Law Professor Richard Bonnie provides extensive recommendations for curbing ...

Team-based model reduces prescription opioid use among patients with chronic pain by 40 percent

July 17, 2017
A new, team-based, primary care model is decreasing prescription opioid use among patients with chronic pain by 40 percent, according to a new study out of Boston Medical Center's Grayken Center for Addiction Medicine, which ...

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Popular heartburn drugs linked to higher death risk

July 4, 2017
Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School ...

Most reproductive-age women using opioids also use another substance

June 30, 2017
The majority of reproductive-age and pregnant women who use opioids for non-medical purposes also use at least one other substance, ranging from nicotine or alcohol to cocaine, according to a University of Pittsburgh Graduate ...

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.