Yesterday a panel of federal medical experts agreed that a sleep aid manufactured by Merck, suvorexant, appears to be safe and effective. The drug is used to help insomnia patients get to sleep and stay in slumber, and the Food and Drug Administration (FDA) panel voted that the pill was effective for this purpose, and in a separate vote, that the drug appears safe at the recommended dosage.
Evidence from company trials however, shows that the drug can have side effects that include daytime sleepiness, suicidal thoughts and challenges behind the wheel. The FDA’s own scientists had issued a negative review of the pill earlier in the day, prior to voting. The FDA is not required to follow its experts’ recommendations.
Instances from pharmaceutical trials were cited by the FDA experts, including 5 women (or about 5% of patients) that had to discontinue a supervised driving test because they were too exhausted, as well as a 59-year-old man that allegedly fell asleep at a traffic light and veered off the road while on the medication.
The presenter of the findings, Dr. Ronald Farkas, speaking on the possibility of making the drug safer, was quoted in the Boston Globe as saying “How many people are you willing to risk versus how much effort are you willing to make?”
What do you think? Is Merck moving too fast despite the trial results? Is there an urgent need for an additional insomnia medication on the market?