The announcement Monday from the Food and Drug Administration broadens the drug’s use to older women who have gone through menopause. The pill, Addyi, was first approved 10 years ago for premenopausal women who report emotional stress due to low sex drive.

Addyi, marketed by Sprout Pharmaceuticals, was initially expected to become a blockbuster drug, filling an important niche in women’s health. But the drug came with unpleasant side effects including dizziness and nausea, and it carries a safety warning about the dangers of combining it with alcohol.

The boxed warning cautions that drinking while consuming the pill can cause dangerously low blood pressure and fainting. If patients have several drinks, the label recommends waiting a few hours before taking the drug, or skipping one dose.

Sales of Addyi, which acts on brain chemicals that affect mood and appetite, fell short of Wall Street’s initial expectations. In 2019, the FDA approved a second drug for low female libido, an on-demand injection that acts on a different set of neurological chemicals.

Sprout CEO Cindy Eckert said in a statement the approval “reflects a decade of persistent work with the FDA to fundamentally change how women’s sexual health is understood and prioritized.” The company, based in Raleigh, North Carolina, announced the FDA update in a press release Monday.

The medical condition for a troublingly low sexual appetite, called hypoactive sexual desire disorder, has been recognized since the 1990s and is thought to affect a significant portion of American women, according to surveys. After the blockbuster success of Viagra for men in the 1990s, drugmakers began pouring money into research and potential therapies for sexual dysfunction in women.

But diagnosing the condition is complicated because of how many factors can affect libido, especially after menopause, when falling hormone levels trigger a number of biological changes and medical symptoms. Doctors are supposed to rule out a number of other issues, including relationship problems, medical conditions, depression and other mental disorders, before prescribing medication.

The diagnosis is not universally accepted, and some psychologists argue that low sex drive should not be considered a medical problem.

The FDA rejected Addyi twice prior to its 2015 approval, citing the drug’s modest effectiveness and worrisome side effects. The approval came after a lobbying campaign by the company and its supporters, Even the Score, which framed the lack of options for female libido as a women’s rights issue.

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This story has been updated to correct the age range of the FDA approval update. The agency approved the drug for postmenopausal women up to age 65, not older than 65.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

Paramount Skydance Corp.’s hostile bid to snatch Warner Bros. Discovery Inc. from under the nose of Netflix Inc. encapsulates the themes that have shaped a banner year for mergers and acquisitions: renewed desire for transformative tie-ups, massive checks from Wall Street, the flow of Middle East money and US President Donald Trump’s role as both disruptor and dealmaker.

Global transaction values have risen around 40% to about $4.5 trillion this year, data compiled by Bloomberg show, as companies chase ultra-ambitious combinations, emboldened by friendlier regulators. That’s the second-highest tally on record and includes the biggest haul of deals valued at $30 billion or more.

“There’s a sentiment in boardrooms and among CEOs that this is a potential multi-year window where it’s possible to dream big,” said Ben Wallace, co-head of Americas M&A at Goldman Sachs Group Inc. “We’re at the beginning of a rate-cutting cycle so there’s anticipation that there will be more liquidity.”

Beyond Netflix’s purchase of Warner Bros., this year’s blockbusters include Union Pacific Corp.’s acquisition of rival railroad operator Norfolk Southern Corp. for more than $80 billion including debt, the record leveraged buyout of video game maker Electronic Arts Inc., and Anglo American Plc’s takeover of Teck Resources Ltd. to reshape global mining. 

“When you look around and you see your peers doing these big deals and taking advantage of the tailwinds, you don’t want to be left out,” said Maggie Flores, partner at law firm Kirkland & Ellis LLP in New York. “The regulatory environment is in a position that is very conducive to dealmaking and people are taking advantage of it.”

The tally also shows a level of exuberance in certain pockets that some advisers and analysts worry is unsustainable. Global trade tensions are ongoing, and market observers are increasingly warning of a selloff in the white-hot equity markets that have underpinned the M&A resurgence.

Top executives at Goldman Sachs, JPMorgan Chase & Co. and Morgan Stanley have all flagged the risk of a correction in the months ahead, in part tied to concerns about an overheated artificial intelligence ecosystem, where huge amounts of investment have juiced technology stocks.

“These equity returns are really coming out of AI, and AI spend is not sustainable,” said Charlie Dupree, global chair of investment banking at JPMorgan. “If that pulls back, then you are going to see a broader market that isn’t really advancing.”

The AI buzz led to some the year’s standout transactions. Sam Altman’s OpenAI took in major investments from the likes of SoftBank Group Corp., Nvidia Corp. and Walt Disney Co., and a consortium led by BlackRock Inc.’s Global Infrastructure Partners agreed to pay $40 billion for Aligned Data Centers. In March, Google parent Alphabet Inc. framed its $32 billion acquisition of cybersecurity startup Wiz Inc. as a way to provide customers with new safeguards in the AI era.

“Everyone needs to be an AI banker now,” said Wally Cheng, head of global technology M&A at Morgan Stanley. “Just as software began eating the world 15years ago, AI is now eating software. You have to be conversant in AI and understand how it will affect every company.”