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Author Topic: FDA Approves Intermezzo for Middle-of-the-Night Waking  (Read 1341 times)

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Offline Miss Philicia

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FDA Approves Intermezzo for Middle-of-the-Night Waking
« on: November 28, 2011, 08:03:04 AM »
source

November 23, 2011 -- The U.S. Food and Drug Administration today approved Intermezzo (zolpidem tartrate sublingual tablets) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.

This is the first time the FDA has approved a drug for this condition. Intermezzo should only be used when a person has at least four hours of bedtime remaining. It should not be taken if alcohol has been consumed or with any other sleep aid.

Insomnia is a common condition in which a person has trouble falling or staying asleep. It can range from mild to severe, depending on how often it occurs and for how long. Insomnia can cause excessive daytime sleepiness and lack of energy. It also can make a person feel anxious, depressed, or irritable. People with insomnia may have trouble focusing on tasks, paying attention, learning, and remembering.

Zolpidem tartrate was first approved in the United States in 1992 as the drug Ambien. Intermezzo is a lower dose formulation of zolpidem. The recommended and maximum dose of Intermezzo is 1.75 milligrams for women and 3.5 mg for men, taken once per night. The recommended dose for women is lower because women clear zolpidem from the body at a lower rate than 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,” said Robert Temple, M.D., deputy center director for clinical science in the FDA’s Center for Drug Evaluation and Research. “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.”

Intermezzo was studied in two clinical trials involving more than 370 patients. In the studies, patients taking the drug had a shorter time to fall back asleep after waking compared to people taking an inactive pill (placebo). The most commonly reported adverse reactions in the clinical trials were headache, nausea and fatigue.

Like other sleep medicines, Intermezzo may cause serious side effects, including getting out of bed while not fully awake and doing an activity that you do not know you are doing or do not remember having done. Reported activities while under the influence of sleep medicines include driving a car, making and eating food, having sex, talking on the phone, and sleep walking—without knowing at the time or remembering later. Chances of such activity increase if a person has consumed alcohol or taken other medicines that make them sleepy.

Intermezzo is a federally controlled substance because it can be abused or lead to dependence.

Intermezzo is made by Transcept Pharmaceuticals Inc. of Port Richmond, Calif.
"I’ve slept with enough men to know that I’m not gay"

Offline Jeff G

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Re: FDA Approves Intermezzo for Middle-of-the-Night Waking
« Reply #1 on: November 28, 2011, 08:28:57 AM »
That's interesting ... maybe there is hope for a good night sleep for us that's on atripla now !

I wake up about 3 or 4 nights a week at about the same time of night and cant go back to sleep and then have to take a nap or I will fall asleep very early in the evening and wake up 6 or 7 hours later . It can ruin my week if I have things planned , Im often so tired I cant enjoy things . 

Offline odyssey

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Re: FDA Approves Intermezzo for Middle-of-the-Night Waking
« Reply #2 on: November 28, 2011, 09:37:54 AM »
Sounds promising! I know I have that problem. Middle of the night and I'm awake over and over and over...

Strange question now: If a poz person were to have sex with a neg person, unprotected under the situation described, i.e. not being aware of it because they were asleep on the drug, and the neg person seroconverted, would the poz person get charged with a crime?
01/09/09- diagnosed HIV+
01/16/09   CD4-425    22%  VL- 32,415
11/09- started Reyetaz/Norvir/Truvada
03/10- stopped R/N/T
10/18/11   CD4- 328   20%  VL- 84,000
10/25/11   CD4- 386   22%
10/28/11- start Truvada/Reyetaz/Norvir
12/30/11  CD4- 523  29%
03/08/12  CD4- 503  31%  VL 57
07/02/12  CD4- 897  43%
08/31/12  CD4- 745  39%
12/27/12  CD4- 884  40%
03/28/13  CD4- 819  39%
07/19/13  CD4- 739  40%
10/17/13  CD4- 535  36%
01/16/14  CD4- 743  43%

02/14- switched from R/N/T to Tivicay/Epzicom because of CKD 3 suspected from tenofovir.

03/14- switched back to R/N/T due to severe nausea and inability to eat on T/E.
 
04/01/14 CD4- 898  42%   VL-

Offline Miss Philicia

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Re: FDA Approves Intermezzo for Middle-of-the-Night Waking
« Reply #3 on: November 28, 2011, 05:42:15 PM »

Strange question now: If a poz person were to have sex with a neg person, unprotected under the situation described, i.e. not being aware of it because they were asleep on the drug, and the neg person seroconverted, would the poz person get charged with a crime?

Fascinating... am I to assume that the neggie would have no idea that the pozzie is, in fact, a pozzie with a sleep disturbance that could lead to such a situation. Something about this reminds of asking what happens if the sun doesn't rise in the morning.
"I’ve slept with enough men to know that I’m not gay"

Offline OneTampa

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Re: FDA Approves Intermezzo for Middle-of-the-Night Waking
« Reply #4 on: December 01, 2011, 09:30:32 PM »
Fascinating... Something about this reminds of asking what happens if the sun doesn't rise in the morning.

I know!  I know!  We won't have to wear our daytime makeup?
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