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"FDA approves new treatment for insomniacs"


Source: CTV.CA

Published: 23 Jul 2022

Category: Pharmaceutical

Rating: (1 stars)

what they said (Hover the mouse cursor over underlined words for more info)

The U.S. government approved a new treatment for insomnia on Friday, the first prescription sleep aid not designated as a controlled substance. Called Rozerem, the drug works differently from its competitors.

Rozerem is chemically related to the natural hormone melatonin, which helps regulate the body's sleep-wake cycle, and is thought to work by stimulating melatonin receptors in the brain, explained Dr. Robert Meyer of the Food and Drug Administration.

"It's another option" for people with the main form of insomnia, difficulty in falling asleep, Meyer said. "By working through a different pathway, it's entirely possible that this might work for some people in ways that the other drugs do not."

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how did it rate? (more information)

Criteria Rating
Total Score 1 of 8
Availability of Treatment Not Satisfactory (?)
Novelty of Treatment Satisfactory (?)
Disease Mongering Not Satisfactory (?)
Treatment Options Not Satisfactory (?)
Costs of Treatment Not Applicable
Evidence Not Satisfactory (?)
Quantification of Benefits of Treatment Not Satisfactory (?)
Harms of Treatment Not Applicable
Sources of Information Not Satisfactory (?)
Relies on Press Release Not Applicable
Quantification of Harms of Treatment Not Satisfactory (?)

what we said (Hover the mouse cursor over underlined words for more info)

This is a short and unsatisfactory story about a new sleeping aid, Rozerem, which reads more like an advertisement than a piece of journalism. The reference to evidence is scant and a proper discussion of benefits and harms related to the treatment is non-existent.

While the article reports USFDA approval, we have no idea if the drug will be available in Canada, as we aren't told if and when Health Canada will approve it.

Finally, by reporting that "1/3 of adults have trouble sleeping", the story crosses the border into disease mongering.

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