By Matthew Perrone
Associated Press

A federal panel of medical experts said that an experimental insomnia drug from Merck & Co. Inc. appears safe and effective, despite evidence from company trials that the pill can cause daytime sleepiness and difficulty driving. 

A majority of Food and Drug Administration panelists voted Wednesday that Merck's sleeping aid, suvorexant, helped patients get to sleep and stay asleep. In a separate set of votes, the panel voted that the drug appears safe at the starting doses proposed by the company.

The FDA is not required to follow the recommendations of its experts, though it often does.

The panel opinion was somewhat at odds with the agency's own scientists, who issued a negative review of the drug earlier in the day. FDA staff pointed out that suvorexant was associated with daytime drowsiness, driving difficulties and suicidal thinking in trials conducted by Merck.

"How much is it worth to try and make the drug safer? How many people are you willing to risk versus how much effort are you willing to make?" said Dr. Ronald Farkas, who presented the FDA's findings.

The FDA drew attention to five women, or roughly 5 percent of patients, who had to stop a supervised driving test because they were too sleepy to continue. In another case, a 59-year-old man reportedly fell asleep at a traffic light and later veered off the road while taking the drug.

The FDA suggested that a lower dose of 10 milligrams might be safer for patients than the higher doses proposed by Merck.

But a majority of panelists endorsed the safety of initial doses proposed by Merck: 15 milligrams or 20 milligrams a day for elderly patients or non-elderly patients, respectively. The panel backed their safety in a vote of 13-3, with one abstention.

"Start low and go slow is likely to be effective," said Dr. Matthew Rizzo of the University of Iowa. "I also think the safety profile of this drug is not any worse and likely better than the drugs we are already using."

Much the meeting's discussion focused on the shortcomings of sleeping pills already on the market, most of which are also associated with lingering drowsiness.

In January, the FDA required drugmakers of Ambien and similar sleeping pills to lower the doses of their medications, based on studies showing that the drugs remain in the bloodstream at levels high enough to interfere with driving.

The panel narrowly voted 8-7, with one abstention, against doses as high as 30 milligrams and 40 milligrams, saying they could exacerbate problems with drowsiness and narcolepsy.

"I think the risks are substantial and it seemed to go up with the higher dose," said Natalie Portis, the panel's patient representative.

Merck has suggested raising patients' prescriptions to the higher levels if they do not respond to lower doses.

If the FDA ultimately approves suvorexant, it will be the first in a new group of drugs that aid sleep by blocking chemical messengers that keep people awake.

A Merck spokeswoman said Wednesday the FDA is expected to issue a decision on suvorexant by mid-year. If approved the drug will have to be scheduled as a controlled substance by the Drug Enforcement Administration.

Shares of the Whitehouse Station, N.J., company fell 62 cents to close at $46.71. 

By MyHealthNewsDaily.com

Constant exposure to light at night can cause depression, a new study in animals suggests.

In the study, hamsters exposed to dim light at night for four weeks showed signs of depression, such as less interest in drinking sugar water they usually enjoy, compared with animals not exposed to light at night, the study found.

The findings suggest exposure to artificial light at night may have contributed to the rising rates of depression over the last 50 years, said study researcher Tracy Bedrosian, a doctoral student in neuroscience at Ohio State University.

"The advent of electrical lighting permitted humans to stray from natural day-night cycles," potentially disturbing our biological rhythms and leading to changes in behavior, Bedrosian said.

But the study also suggests good news: the negative effects of light at night were reversed in the animals after just two weeks of normal lighting conditions, the researchers said.

"People who stay up late, in front of the television and computer, may be able to undo some of the harmful effects just by going back to a regular light-dark cycle and minimizing their exposure to artificial light at night," Bedrosian said.

The findings add to a growing body of research that light at night is bad for health. Earlier studies have found exposure to light at night may increase the risk of weight gain and certain types of cancer.

In the new study, Bedrosian and colleagues placed a group of hamsters in an environment that provided 16 hours of normal daylight, and eight hours of dim light, equivalent to that of a television playing in a dark room. Their behavior was compared to that of a group of hamsters that spent 16 hours in daylight and eight hours in total darkness.

Hamsters exposed to dim light at night were less active each day, and were less mobile when placed in water compared to those that spent their nights in total darkness.

Studies of the hamsters' brains revealed that a protein may play a key role in how exposure to light at night leads to depression, the researchers said.

Hamsters exposed to light at night showed increased expression of the gene that produces the protein, called tumor necrosis factor (TNF). Blocking TNF prevented the development of depression-like symptoms in hamsters, even when they were exposed to light at night, the researchers said.

TNF is part of the body's immune response to infection, and causes inflammation. While this inflammation is necessary to fight off infection, it can be damaging if constant, the researchers said.

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