FDA Calls for Stricter Labels on Sleep Meds


You go to bed at your regular bedtime, 11PM, but an hour later you’re still not asleep. You wait another hour before you finally drift into a peaceful state of sleep. This state doesn’t last long, however. You sleep for two hours before you wake up again. After that, you drift into sleep for short periods of time with frequent waking. This has been occurring every night for a month now. It’s beginning to affect your work performance and you’re worried about losing your job.
A majority of Americans possess difficulty sleeping, whether they cannot get to sleep or have trouble staying asleep. While it is normal to experience occasional difficulty sleeping; regular difficulty getting to sleep or staying asleep is a problem.

For this reason, a lot of Americans have been prescribed sedative-hypnotic medication to help them achieve better sleep. These medications tend to affect individuals differently. The United States Food and Drug Administration has noticed that too many individuals are suffering negative side-effects of these types of drugs. They have requested pharmaceutical companies who manufacture sedative-hypnotic medications to issue labels that contain stronger warnings about the possible negative side-effects of these drugs. Choosing medication is like choosing the products we buy online. I have been a face of vitamin c serum for face reviews and it really help me in choosing what to put on my face. Same goes with medications.

Some individuals on sedative-hypnotic medications experience complex sleep behaviors such as sleep-walking, cooking and/or eating while sleeping, making phone calls while sleeping, and even driving in their sleep. When these behaviors occur in one’s sleep the individual does not remember engaging in the activity.

Other individuals have had severe allergic reactions to sleep medicines, including facial swelling. Severe allergic reactions can even occur the first time a patient takes a sedative-hypnotic drug.

The FDA has been working with manufacturers to change sleep medication labels and to notify consumers and health care professionals of these medications’ adverse side effects.

The FDA is also requesting sedative-hypnotic manufacturers to create Patient Medication Guides to inform patients about the possible adverse side-effects of the drugs. These medication guides are handed out when the medication is dispensed. The guides will provide information about the medication’s risks, precautions patients can take, the proper use of the pills, and recommendations from the FDA regarding sleep medicine.

Finally, the FDA has advised pharmaceutical companies who produce sedative-hypnotic drugs to conduct clinical studies that will examine the frequency with which sleep driving, sleep walking, and other complex sleep behaviors occur.

The sleep medications the FDA is working with manufacturer companies to revise labels include:


-Ambien CR













For more information regarding sedative-hypnotic medications or sleep disorders, please visit the FDA on-line.

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