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The FDA approved Merck's new type of sleeping pill designed to help people with insomnia stay asleep.

(Tony Kurdzuk/The Star-Ledger)

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

The tablet, Belsomra — which had been called Suvorexant at clinical trials — 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 highly-anticipated drug today 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.

Merck's late-stage trials of the drug showed it improved a person's ability to fall asleep and stay asleep, made them less drowsy the next day and had no significant withdrawal symptoms.

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.

Last month, Whitehouse Station-based Merck announced a string of experimental drugs, including the as-yet unnamed Belsomra, that were expected to launch in the near future and that hold blockbuster sales potential.

Today, the FDA said it is requiring that patients who get Belsomra 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 rose 82 cents, or 1.4 percent, to close at $57.85.

Star-Ledger staff writer Alexi Friedman contributed to this report.

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