A new sleeping pill is on the market for patients with insomnia. Its name is Intermezzo and what makes this sleeping pill unique and potentially dangerous is that it is for “middle of the night” insomnia. The drug is made by Transcept Pharmaceuticals and is being marketed by Purdue Pharma (the maker of OxyContin) as their latest blockbuster drug. Purdue Pharma is spending $100 million on sales and marketing to promote Intermezzo.
Intermezzo is the first sleeping pill approved by the Food and Drug Administration to treat people who wake up in the middle of the night and are unable to get back to sleep.
The spearmint flavored drug is taken sublingually (under the tongue) and is meant to be taken “while in bed.” The active ingredient is zolpidem, which is also the active ingredient in the popular sleeping pill Ambien. By taking Intermezzo sublingually about 25% of the dosage is quickly absorbed through the tissues of the mouth, producing a rapid onset of sleep — thus the rationale for taking the sleeping pill while in bed. The remainder of the dose is swallowed and maintains sleep for the rest of the night.
The FDA says the drug is a “safer choice” than Ambien because it contains a smaller dose of zolpidem. “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,” said Robert Temple, MD, deputy center director for clinical science for the FDA.
The risk of next-day driving impairment is increased if Intermezzo is taken with alcohol or other drugs. And the label warns people not to drive for at least one hour after waking and at least five hours after taking Intermezzo.
Side Effects of Intermezzo
The FDA approved Intermezzo after two small clinical trials involving only 370 patients. The studies were relatively short (a few weeks in duration), and it is not clear if the drug is effective or can cause addiction when used for more than 35 days. The most common adverse reactions to Intermezzo in the trials were headache, nausea and fatigue.
When patients wake in the morning, they should wait until they are fully awake before driving or engaging in other activities requiring mental alertness. Patients should not do dangerous activities until they know how Intermezzo affects them. Abnormal thinking and behavior changes have been reported in patients while under the influence of sleep medicines such as zolpidem; including driving or eating while not fully awake, having sex, talking on the phone, sleep walking, hallucinations and other bizarre behavior that patients often have no recollection of doing.
I have problems with Intermezzo — big problems. First, it is being marketed by a pharmaceutical company that lied about a very dangerous drug called OxyContin. We are now immersed in OxyContin deaths and addictions throughout the U.S. and Canada because of Purdue Pharma’s criminal marketing.
Intermezzo came on the market in early April. But under FDA rules, Purdue cannot advertise the drug to the public until it has been on the market for at least six months. So for now, Purdue is relying on its sales force – which is marketing Intermezzo directly to doctors.
While talking to my primary care physician recently I asked him about Intermezzo. He was familiar with the drug and impressed with it. I told him that I had concerns with any sleeping pill being taken at 3:00 am and the patient being able to get behind the wheel of a car to drive to work. He told me to do more research before I wrote about Intermezzo because a pharmaceutical representative had told him Intermezzo was to be taken at bedtime — just as Ambien is.
Purdue Pharma representatives lied to the medical profession when they aggressively marketed OxyContin as less likely to be addictive or abused. They couldn’t possibly be repeating this criminal marketing ploy with Intermezzo could they? You interested FDA? Or will you wait until Intermezzo is a train wreck as OxyContin is in every state in the country?
Marianne Skolek is an activist and investigative reporter for Salem-News.com who lost a daughter to prescribed OxyContin in 2002. Marianne writes from the perspective of families devastated by the prescription drug epidemic.
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