FDA Announces Suggested Dosage Change for Sleep Aids
Everyone has experienced at least one sleepless night during his or her lifetime. Some have experienced multiple sleepless nights- often leading to insomnia. A lack of sleep can lead to multiple health issues, including weight gain, anxiety, and an increased risk of serious illnesses. To combat this pesky and often persistent problem, many people turn to insomnia drugs. These drugs induce a sleep allowing the person to wake up refreshed and ready to start the day. However, taking too much of an insomnia drug can lead to adverse effects.
In January, the U.S. Food and Drug Administration (FDA) announced a new requirement that manufacturers of Ambien, Ambien CR, Edluar, and Zolpmist - drugs that contain the active ingredient zolpidem - must lower the recommended doses. This requirement will also apply to generic insomnia drugs. This new requirement comes in light of a new study that shows some patient's blood levels are high enough in the morning after use to impair many activities that require alertness, including driving.
Requiring patients to take a lower dosage will mean less of the drug in the blood in the morning. Studies have shown that zolpidem remains in women's systems longer than men's and as such, the dosage should be lower for women.
Studies also show that the risk for morning impairment is higher in those patients that have taken the extended release tablets. The FDA is strongly recommending that physicians warn their patients of such risks of next morning impairment.
The new recommended dosages of zolpidem are as follows: women's dosage should be lowered from 10 milligrams (mg) to 5 mg for immediate-release products. These include Ambien, Edluar, and Zolpimist. The extended-release products should be reduced from 12.5 mg to 6.25 mg (Ambien CR). The FDA is only recommending that physicians consider prescribing the previously mentioned dosages for men.
The recommended lower dose of zolpidem approved for middle-of-the-night awakenings, Intermezzo, will not be changed. At the time of approval, the drug already recommended a lower dose for women than for men.
While the FDA will continue to investigate the effects of these insomnia drugs, patients should be given these lower dosages and should be made aware to monitor their alertness the morning after taking the medication.