FDA Issues Boxed Warning for Rx Sleeping Pills

U.S. drug regulators have applied a strict new warning for sleeping pills in hopes of preventing dangerous behavior.

Sleeping pills can alter behavior. / Image: Relativity Media
Sleeping pills can alter behavior. / Image: Relativity Media

Characters acting funny after taking sleeping pills is a comedic gag used in TV and movies ad nauseam, mostly because it’s hilarious. Well, according to a recent article from The Washington Post, the FDA isn’t laughing and just added a strict new warning about the dangers of prescription sleeping pills.

The agency tracks side effects though a voluntary reporting system and identified 66 examples of patients who took sleeping aids and then engaged in dangerous activities like sleepwalking or driving while not fully aware. 20 of the incidents resulted in death linked to carbon monoxide poisoning, drowning, fatal falls, hypothermia, car crashes and suicide.

The drugs will now come with boxed warnings, the most severe type of cautionary message the FDA has in its arsenal. The warnings apply to Lunesta, Sonata, Ambien, Edluar, Intermezzo, and Zolpimist.

List: Digitalization Companies From PACK EXPO
Looking for CPG-focused digital transformation solutions? Download our editor-curated list from PACK EXPO featuring top companies offering warehouse management, ERP, digital twin, and MES software with supply chain visibility and analytics capabilities—all tailored specifically for CPG operations.
Download Now
List: Digitalization Companies From PACK EXPO
Pharmaceutical Innovations Report
Discover the latest breakthrough packaging technologies shaping the pharmaceutical sector. This report dives into cutting-edge innovations, from smart containers that enhance patient safety to eco-friendly materials poised to transform the industry’s sustainability practices. All from PACK EXPO. Learn how forward-thinking strategies are driving efficiency and redefining what’s possible in pharma packaging.
Learn More
Pharmaceutical Innovations Report