A B.C. couple who have used the Vancouver-based sleep aid U-Dream are claiming the remedy caused one of them to suffer a near-fatal heart attack.
The claim comes in the wake of news that the product, which markets itself as a natural sleep remedy, was found to contain a compound that’s structurally similar to the pharmaceutical sedative zopiclone by the U.S. Food and Drug Administration (FDA) and Health Canada.
The FDA said the substance discovered, zopiclone impurity 22, is also similar to eszopiclone, another prescription sedative that is the active ingredient in Lunesta.
The Vancouver company behind U-Dream, Biotrade, has told consumers to avoid the product while it conducts its own tests, saying it doesn’t know how the compound made its way into samples that were tested.
Since its introduction two years ago, the product has been flying off the shelves and has been widely popular online, including Amazon.
Belinda Ruckman said she heard about the product on Facebook and thought it would be perfect for her husband, who had been having sleeping issues in the wake of the couple losing their 24-year-old son this summer.
“I heard it was amazing, and that no other sleep product could do what it could do,” she said. She said she was also intrigued by the product’s reported mixture of traditional Eastern medicinal herbs, like passionflower and loquat fruit.
Jim Ruckman said he saw immediate results the first time he took U-Dream.
“I slept for six hours that first night,” he said. “I thought, wow, this is a product that actually works.”
But after 10 straight days of taking U-Dream, Jim suffered a cardiac arrest and died in his bed, only to be revived by the couple’s older son.
Now that she’s heard the news about the discovery of the pharmaceutical compound, Belinda is convinced U-Dream caused her husband’s heart attack.
“He did not have any previous heart issues, he would go for routine medical check-ups. There’s nothing in his past with heart issues,” she said.
Belinda and Jim said they heard from medical officials at the hospital that U-Dream had already been flagged after someone else suffered a similar cardiac event.
“I have no doubt, no doubt at all that they almost killed my husband,” Belinda said. “The cardiologist said, ‘Jim, you died.’ And it’s been nothing but a nightmare for us ever since.”
Other consumers worried
The Ruckmans aren’t the only ones concerned about the news.
Gregory Parson said he needed help sleeping after suffering injuries in a car crash a year ago. Intrigued by the promise of a natural remedy with no side effects, he took his friend’s recommendation to give U-Dream a try.
“It really knocks you out, for sure,” he said. “I was happy that this was a natural, non-addictive product.”
Hearing the FDA’s news that the sleep aid contains a pharmaceutical compound was a wake-up call, he says.
“I kind of wonder how something like this gets into the market, why there’s no inspections or regulations … or maybe there is, and it’s just rigorous enough or frequent enough testing,” he said.
Parson said he’s especially disturbed by the warnings that zopiclone and similar compounds should never be mixed with alcohol or other sleep medications.
He says he sometimes mixed melatonin, another common sleep aid, with U-Dream.
“Very disappointing, and kind of scary too,” he said.
Kathleen McGarvey, a Vancouver-based psychiatrist, said in an email that those pharmaceutical compounds, while effective if safely prescribed, carry serious risks including addiction and impaired driving.
“This is part of a huge trend of so-called natural products containing pharmaceuticals putting the public at serious risk,” she said.
Health Canada has yet to issue a public statement on the discovery of the specific compound.
According to a statement from Biotrade on the U-Dream website, the company was alerted by Health Canada about the discovery on Dec. 17, after the agency told Biotrade the sleep aid had been flagged for an “unknown substance” in November.
The FDA released its public statement about the discovery of zopiclone on Dec. 18, noting that it hasn’t been approved in the U.S.
Biotrade executive Patrick Jackson told Global News that the company is committed to getting to the bottom of what happened, but insists zopiclone and other pharmaceutical compounds aren’t meant to be in U-Dream.
“What we’re doing right now is investigating exhaustively to try and answer that question to our own satisfaction, so we can take corrective action,” he said Saturday.
The company has also said there have not been any confirmed cases of illness or irregular symptoms linked to U-Dream.
But Belinda Ruckman said she contacted Biotrade earlier this month after first hearing about the company’s voluntary recall. After they called her back, Belinda recorded the phone call.
“They were not very transparent, and they downplayed everything,” she said. “I told them what happened to Jim, but there’s been no urgency on their part.”
Belinda said she is urging the company to come forward with everything it knows about the product and what goes into it, in the hopes more lives can potentially be saved.
“It’s unbelievable,” she said. “You think that a company has a duty of care to the public. When I tell them Jim had a heart attack, he had no other issues … I asked them how they’re going to support us, and they said, ‘By being understanding.’
“People who have cardiac events at home, very few survive,” Belinda added through tears. “Jim’s one of the lucky ones.”