There are at least a handful of us waking up in the middle of the night and finding it difficult to fall asleep again. For the first time ever, the Food and Drug Administration (FDA) has approved a drug namely Intermezzo for insomnia characterized by sudden wakefulness during midnight.
This medicine ought to be used only when a person has about 4 hours of sleep still to go. Also, individuals under the influence of alcohol or other sleep inducing drugs should refrain from using this drug.
A medicine called zolpidem tartrate was the first to gain approval for the treatment of insomnia in 1992. Intermezzo is a lower dose constitution of zolpidem. As per the guidelines, a maximum dosage of 1.75mg for women and 3.5mg for men has been approved for use once every night. Women are exposed to a lower dose since their bodies flush out zolpidem from the body at a lower speed as compared to men.
“For people whose insomnia causes them to wake in middle of the night with difficulty returning to sleep, this new medication offers a safer choice than taking a higher dose of zolpidem upon waking. With this lower dose there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving,” remarked Robert Temple, M.D., deputy center director for clinical science in the FDA’s Center for Drug Evaluation and Research.
The 2 clinical trials enrolled above 370 patients, where one group was administered Intermezzo and the other group a placebo. Reportedly, those in the former set took less time to fall asleep again after waking up at midnight, unlike those on placebo. However, some of the side-effects of Intemezzo found in this study were headache, nausea and tiredness. The aforesaid drug may also result in persons engaging in certain activities in half sleep and not remembering these events later.
Transcept Pharmaceuticals have manufactured Intermezzo.