Merck & Co. Wins U.S. FDA Approval of New Type of Sleeping Pill

Aug 14, 2014 12:01 am ET

Aug. 14 (Bloomberg) -- Merck & Co., the second-largest U.S. drugmaker, won approval to sell its treatment for insomnia, a new type of drug considered to have fewer side effects than older pills such as Ambien.

The Food and Drug Administration cleared the sleeping pill called Belsomra in lower doses than Whitehouse Station, New Jersey-based Merck originally sought to market, according to a statement yesterday from the agency. The drug may generate $305 million in sales in 2017, according to the average of six analysts’ estimates compiled by Bloomberg, down from $516 million forecast before the FDA last year rejected the highest doses as possibly unsafe.

Suvorexant, the chemical name for Belsomra, is designed to turn off wakefulness while commonly used sleeping pills such as Sanofi’s Ambien and Sumitomo Dainippon Pharma Co.’s Lunesta calm the brain. The Drug Enforcement Administration must determine prescribing restrictions before the drug can hit the market. Merck expects to make Belsomra available late this year or early in 2015, the company said in a statement.

“To assist health care professionals and patients in finding the best dose to treat each individual patient’s sleeplessness, the FDA has approved Belsomra in four different strengths -– 5, 10, 15, and 20 milligrams,” Ellis Unger, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research, said in the statement. “Using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness.”

Sleep Issues

About 60 million Americans a year have insomnia frequently or for extended periods of time, according to the National Institutes of Health. Sales of generic and brand-name sleep aids totaled $1.5 billion last year, according to IMS Health Holdings Inc., a Danbury, Connecticut-based data analysis firm. The bulk of prescriptions, 41 million of 56 million, were written for generic versions of Ambien and Ambien CR.

Belsomra works by altering the action of orexins, chemicals involved in the sleep-wake cycle that play a role in keeping people awake, the FDA said in its statement. The drug is the first orexin receptor antagonist approved by the agency for sleep issues.

FDA staff expressed concern when first considering the drug in May 2013 that patients who took higher doses of suvorexant experienced a greater risk of next-day drowsiness. The agency determined safety data didn’t support sales of the 30 milligram and 40 milligram doses and directed Merck to start patients at doses lower than 15 milligrams.

Similar Rules

The DEA has proposed to treat Belsomra like other sedative sleep aids that are considered to have a low potential for abuse compared with most other controlled substances yet still require some prescribing restrictions, such as how often the medicines can be refilled.

Merck gained 1.4 percent to $57.85 at the close in New York. The company’s shares have increased 19 percent in the past 12 months.

Before approving the drug, the FDA asked Merck to conduct a study on Belsomra’s effect driving the day after taking the drug. The study showed impaired driving in those who used the 20-mg dose, spurring the agency to say patients getting that dose should be cautioned against driving the day after.

Side effects of the drug include sleep-driving and other complex behaviors while not fully awake, such as preparing and eating food, making phone calls, or having sex, the FDA said.

Makers of sleep aids like Ambien that contain the active ingredient zolpidem were told by the FDA in January 2013 to lower by half the recommended doses for women. Zolpidem stays in women’s bodies longer than had previously been known and can impair activities such as driving. In May, the agency also cut in half the recommended starting dose of Lunesta for men and women.