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A new sleeping pill, Intermezzo, is now available for patients struggling with insomnia. What makes this sleeping pill interesting and potentially dangerous is that it is intended for “middle of the night” insomnia.
The medicine is manufactured by Transcept Pharmaceuticals but is being marketed by Purdue Pharma (the maker of OxyContin) as their most recent blockbuster drug. Purdue Pharma is using $100 million on sales and marketing to promote Intermezzo.
Intermezzo is the first-ever sleeping pill approved by the Food and Drug Administration to treat people who lose sleep in the middle of the night and can’t get back to sleep.
The spearmint flavored drug is administered sublingually (under the tongue) and is meant to be used “while in bed.” Its active ingredient is zolpidem, which is also the active ingredient in the famous sleeping pill Ambien.
Upon taking Intermezzo sublingually, about 25% of the dosage is quickly absorbed through the mouth tissues, producing a rapid onset of sleep — thus the rationale for taking the sleeping pill while in bed. The rest of the dose is swallowed and maintains sleep for the rest of the night.
The FDA considers the drug to be a “safer choice” than Ambien because it contains smaller doses of zolpidem.
Robert Temple, MD, deputy center director for clinical science for the FDA, said that 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 impairments driving.
However, the risk of next-day driving impairment is increased if Intermezzo is taken along with alcohol or other drugs. Furthermore, the label warns people not to drive for at least one hour after waking and at least five hours after taking Intermezzo.
Intermezzo Drug Addiction reports: Side Effects
The FDA approved Intermezzo after two minor clinical trials involving just 370 patients. The studies only lasted a few weeks, and it is not clear if the drug is helpful or can cause addiction when used for more than 35 days.
The most recurrent adverse reactions to Intermezzo in the trials were headache, nausea, and fatigue.
Patients should wait until they are fully awake in the morning before driving or engaging in other activities that need mental alertness. Patients should not engage in intense or 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.
These include driving or eating while not fully awake, having sex, talking on the phone, sleepwalking, hallucinations, and other bizarre behavior that patients often have no recollection of doing.
There may be some significant issues with Intermezzo. First, the pharmaceutical company marketing it lied about a hazardous drug called OxyContin.
The US and Canada are now immersed in OxyContin deaths and addictions because of Purdue Pharma’s unethical marketing.
Intermezzo came on the market in early April. But according to 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.
Purdue Pharma representatives lied to the medical profession when they aggressively marketed OxyContin as less likely to be addictive or abused. It is impossible not to think that they could possibly be repeating this criminal marketing ploy with Intermezzo. Vigilance is advisable.
Reach Out Now
At United Recovery Project, we offer intensive and unique programs for patients dealing with Intermezzo addiction and other kinds of drug addictions. We offer various luxury treatment services to our patients including: drug detox, partial hospitalization programs, intensive outpatient programs & sober living and alumni program.
Throughout your stay at the facility, you will be monitored by a team of specialists to ensure you have a comfortable and safe recovery process.
If you or someone you love is struggling with a Intermezzo addiction, do not hesitate to call us on: 855-580-4810 to start your drug addiction treatment.
References and Resources
- Intermezzo Medication