FDA Scrutinizes Effects of Sleep Drugs

The NY Times jumped into the sleep-related media fray with a feature that addressed the flip side of sleep—waking up. Reporter Katie Thomas reports that the FDA is taking heightened interest in the issue thanks to new evidence that suggests the effects of well-known sleep drugs could persist into the day.

Of particular interest is a possible link between sleep drugs and car accidents. With studies showing about 60 million prescriptions for sleep aids in the United States last year, the problem (if it exists) could be widespread.

The NY Times points out that relative newcomers such as Intermezzo from Purdue Pharma could help pave the way for appropriate dosing guidelines. In 2011, the FDA recognized gender variability when it approved the sleep drug Intermezzo, which treats patients who wake up in the middle of the night.

Women get a lower dose of Intermezzo (active ingredient Zolpidem) and all users are warned to only take the drug if they have four hours or more of bedtime left. “The agency’s experience with Intermezzo,” writes Thomas, “along with other research, led it to order in January that the dosage for all drugs containing zolpidem — the active ingredient in Intermezzo, as well as Ambien and related generic sleep drugs — be halved for women.”

Despite the increased scrutiny for sleep drugs, the NY Times highlighted the inherent paradox of the sleep drug/sleepiness situation. “What we have to weigh here is that people who don’t sleep well are a hazard on the road because they do fall asleep while driving,” said Robert Voas, a senior research scientist at the Pacific Institute for Research and Evaluation and an expert on driving safety in the Times article. “There’s risks on both sides.”

Source: NY Times

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