FDA approves new sleeping drug from Merck (Update)

by Matthew Perrone

Merck & Co. Inc. has won federal approval for a new type of sleeping pill designed to help people with insomnia stay asleep.

The tablet, Belsomra, works by temporarily blocking chemicals known as orexins that control the sleep cycle and can keep people awake at night. It's unclear whether the new drug is safer or more effective than older drugs because it was tested against a dummy pill, rather than other sleeping medications.

The Food and Drug Administration approved the drug Wednesday in four different doses for various degrees of insomnia. The agency noted that patients who took the highest dose, 20 milligrams, experienced drowsiness and difficulty driving the next morning.

Doctors should warn patients taking the highest dose against next-day driving or activities that require full concentration, the FDA said. It added that side effects such as next-day drowsiness can be reduced by using the lowest effective dose. Drowsiness is a side effect listed on the labels of all anti-insomnia drugs.

In the last year, the FDA lowered the recommended dosage on Ambien, Lunesta and related drugs based on studies showing a link to driving problems and impaired memory and coordination. The agency cited research showing that the drugs remain in the bloodstream at levels high enough to interfere with activities that require focus and attention.

The FDA is requiring that patients who get the new drug receive a medication guide detailing the drug's potential safety issues, including sleep-walking, sleep-driving and other semi-awake activities.

The agency said it approved Belsomra based on three company studies involving 500 patients that showed people taking it fell asleep faster and spent less time awake compared with people taking a dummy pill.

Like other prescription sleeping drugs, Belsomra is designed to be taken only once per night and only when patients have at least seven hours before they need to wake up.

Shares of Merck & Co. Inc., which is based in Whitehouse Station, New Jersey, rose 82 cents, or 1.4 percent, to close at $57.85.

5 /5 (1 vote)
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.

US lowers Lunesta dose due to next-day drowsiness

May 15, 2014

U.S. health officials are lowering the starting dose of the popular sleeping aid drug Lunesta, due to risks of morning drowsiness that can impair driving ability and lead to injury.

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.

Recommended for you

Experts want restrictions on testosterone drug use (Update)

Sep 17, 2014

Federal health experts said Wednesday there is little evidence that testosterone-boosting drugs are effective for treating common signs of aging in men and that their use should be narrowed to exclude millions of Americans ...

User comments