Neuroscience
From the FDA:
For Immediate Release: Nov. 23, 2011
FDA approves first insomnia drug for middle-of-the-night waking followed by difficulty returning to sleep
[snippet]
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.
[snippet]
Read the full press release
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- Business World: Emd 281014 And Insomnia
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Neuroscience
FDA: Insomnia Drug Approval
From the FDA:
For Immediate Release: Nov. 23, 2011
FDA approves first insomnia drug for middle-of-the-night waking followed by difficulty returning to sleep
[snippet]
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.
[snippet]
Read the full press release
- Not Such A Bad Night's Sleep
From 'The Archives', first published in the Digest 2/2/2004 For the 33 percent of Americans who suffer from insomnia, a good night's sleep is no more than a dream. Part of the their problem could be that they overestimate how long it takes...
- You're Feeling Very Sleepy
Just thinking that they’ve not had much sleep could interfere with the daytime functioning of imsomniacs, regardless of whether they actually had enough sleep or not. Twenty-two students (average age 21 years) with primary insomnia were recruited by...
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From the FDA: FDA Approves Saphris to Treat Schizophrenia and Bipolar Disorder The U.S. Food and Drug Administration has approved Saphris tablets (asenapine) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder, and to treat...
- Fda Approves Invega (paliperidone)
An FDA Press Release: FOR IMMEDIATE RELEASE P06-208 December 20, 2006 Media Inquiries: Press Office, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Approves New Drug for Schizophrenia The Food and Drug Administration (FDA) today approved Invega (paliperidone)...
- Business World: Emd 281014 And Insomnia
From the New York Times website: Lilly to Buy Insomnia Compound By THE ASSOCIATED PRESS Published: October 28, 2004 Filed at 11:21 a.m. ET INDIANAPOLIS (AP) -- Eli Lilly and Co. will pay a German pharmaceutical company $29 million for the...