Archive
New From the GAO
New GAO Report and Press Release
Source: Government Accountability Office
Report
1. Prescription Drugs: Comparison of DOD and VA Direct Purchase Prices. GAO-13-358, April 19.
http://www.gao.gov/products/GAO-13-358
Highlights – http://www.gao.gov/assets/660/654020.pdf
Press Release
1. GAO Fills Vacancy on Health Information Technology Policy Committee May 20.
http://www.gao.gov/press/gao_fills_vacancy_hit_committee.htm
Declining Medicine Use and Costs: For Better or Worse? A Review of the Use of Medicines in the United States in 2012
Declining Medicine Use and Costs: For Better or Worse? A Review of the Use of Medicines in the United States in 2012 (PDF)
Source: IMS Institute for Health Informatics
From press release:
Total spending on U.S. medicines fell 3.5 percent on a real per capita basis in 2012 and the use of healthcare services overall declined for the second consecutive year, according to a new study released today by the IMS Institute for Healthcare Informatics.
The report – Declining Medicine Use and Costs: For Better or Worse? – finds that total dollars spent on medications in the U.S. reached $325.8 billion last year, or real per capita spending of $898, down $33 from 2011. Underlying drivers for the overall decline in healthcare service use included fewer patient visits to office-based physicians, fewer non-emergency admissions to hospitals and outpatient facilities, and a less severe flu season in the early part of 2012. Patent expiries in 2012 contributed $28.9 billion to the reduction in medicine spending. This was their largest-ever impact as millions of patients accessed lower-cost generic versions of additional medicines.
Patients with insurance paid higher deductibles, copays and co-insurance for their overall healthcare, but prescription drug copays for most patients declined. At the same time, new transformative medicines became available to treat a large number of diseases with small or strictly defined patient populations.
Safety of antidepressants in adults aged under 65: protocol for a cohort study using a large primary care database.
Source: BMC Psychiatry
Background
Antidepressants are among the most commonly prescribed drugs in primary care in England and their use is increasing. This is largely due to longer durations of treatment of depression. Observational studies have shown some differences in adverse outcomes associated with different antidepressant drugs but relatively little is known about their relative safety particularly with long term use. The primary aim of this study is to determine the relative and absolute risks of pre-defined adverse events comparing different classes of antidepressant drugs in adults aged under 65 years and diagnosed with depression.
Methods/design
The study will identify a cohort of patients with a first recorded diagnosis of depression between 1/1/2000 and 31/07/2011, and made between the ages of 20 to 64 years using a large primary care database (QResearch). Patients will be followed up until 1/08/2012. Details of all prescriptions for antidepressants in patients in the cohort will be extracted, including the date of each prescription, the type of antidepressant drug, the dose and total quantity prescribed. Prospectively recorded data will be used to ascertain information on adverse outcomes that occurred during follow-up and after entry into the cohort. These are: all-cause mortality, suicide, attempted suicide/self-harm, sudden death, antidepressant overdose/poisoning, myocardial infarction, stroke/transient ischaemic attack, cardiac arrhythmia, epilepsy/seizures, upper gastrointestinal bleeding, falls, fractures, adverse drug reactions and motor vehicle crashes. Cox proportional hazard models will be used to estimate the association of the outcomes with class of antidepressant drug adjusting for potential confounding variables. The analyses will also examine associations by duration and dose and with the most frequently prescribed individual antidepressant drugs. Self-controlled case series analyses will be used to estimate the relative incidence of the outcomes of interest for defined time periods of antidepressant use.
Discussion
The results of this study will help to establish the relative safety and balance of risks for different antidepressant drugs in people aged under 65.
Nonmedical Use of Prescription-Type Drugs, by County Type
Nonmedical Use of Prescription-Type Drugs, by County Type
Source: Substance Abuse and Mental Health Services Administration
- About 15.7 million persons aged 12 or older used prescription-type drugs nonmedically in the past year, and 6.7 million did so in the past month.
- Past year nonmedical use of prescription-type drugs was lower among persons living in rural counties than among those in metropolitan and urbanized non-metropolitan counties (5.4 vs. 6.4 and 6.6 percent); past month use was similar among all three types of counties.
- The rate of past year nonmedical use of pain relievers was lower in rural counties than in metropolitan and urbanized non-metropolitan counties (4.2 vs. 4.9 and 5.1 percent), as was the rate of nonmedical use of tranquilizers (1.8 vs. 2.1 and 2.3 percent); the rate of nonmedical use of stimulants and sedatives did not vary by type of county.
The media and intellectuals’ response to medical publications: the anti-depressants’ case
The media and intellectuals’ response to medical publications: the anti-depressants’ case
Source: Annals of General Psychiatry
During the last decade, there was a debate concerning the true efficacy of anti-depressants. Several papers were published in scientific journals, but many articles were also published in the lay press and the internet both by medical scientists and academics from other disciplines or representatives of societies or initiatives. The current paper analyzes the articles authored by three representative opinion makers: one academic in medicine, one academic in philosophical studies, and a representative of an activists’ group against the use of anti-depressants. All three articles share similar gaps in knowledge and understanding of the scientific data and also are driven by an ‘existential-like’ ideology. In our opinion, these articles have misinterpreted the scientific data, and they as such may misinform or mislead the general public and policy makers, which could have a potential impact upon public health. It seems that this line of thought represents another aspect of the stigma attached to people suffering from mental illness.
Markey Report: Compounding Pharmacies Going Untracked, Unregulated, Under-inspected from Coast to Coast
Markey Report: Compounding Pharmacies Going Untracked, Unregulated, Under-inspected from Coast to Coast
Source: U.S. Senator Ed Markey (D-MA)
Compounding pharmacies are going largely untracked, unregulated and under-inspected by states across America, according to a new report released today by Rep. Ed Markey (D-Mass). Following the meningitis outbreak originating in a Massachusetts compounder that killed dozens and sickened hundreds, Rep. Markey, along with Reps. Henry A. Waxman (D-Calif.), John Dingell (D-Mich.), Frank Pallone (D-N.J.) and Diana DeGette (D-Colo.), quizzed all states on their oversight of compounding pharmacies, which mix specialty drugs.
The report, “State of Disarray”, is a shocking compendium of the responses from the states queried in the investigation, showing that they are largely leaving compounding pharmacies to their own devices, without the ability to effectively inspect, track or police activities within states and across state lines when the drugs are shipped.
High-Risk Compounded Sterile Preparations and Outsourcing by Hospitals That Use Them
High-Risk Compounded Sterile Preparations and Outsourcing by Hospitals That Use Them
Source: U.S. Department of Health and Human Services, Office of Inspector General
Summary
WHY WE DID THIS STUDY
A recent nationwide meningitis outbreak caused by contaminated injections, which were compounded by the New England Compounding Center, raised major concerns about the use of drugs supplied by compounding pharmacies. Hospitals may have sourcing arrangements with multiple outside compounding pharmacies and may also compound drugs within their own pharmacies. The meningitis outbreak and its aftermath revealed a gap in information about hospitals’ use of compounded drugs supplied by outside pharmacies and the steps that hospitals take to ensure the quality of compounded drugs.
HOW WE DID THIS STUDY
This study focused on hospital use of compounded sterile preparations (CSPs). CSPs are sterile compounded drugs that are generally administered to patients via injection or infusion. We surveyed a nationally representative sample of 298 acute-care hospitals operating in 2012 that participated in Medicare. We developed and used an online questionnaire to determine the extent and nature of hospital use of CSPs and outsourcing, including the extent to which hospitals outsource versus prepare onsite, and challenges in outsourcing and preparing CSPs. We received responses from 236 hospitals, an overall response rate of 79 percent. In addition, we interviewed stakeholders, including four practicing hospital pharmacists and officials of the trade association that represents hospital pharmacists.
WHAT WE FOUND
In 2012, 92 percent of hospitals used CSPs. Almost all hospitals (92 percent) used sterile-to-sterile CSPs and only 25 percent of hospitals used higher risk nonsterile-to-sterile products. Of the hospitals that used nonsterile-to-sterile CSPs, 85 percent outsourced at least some of these products (i.e., purchased them from outside pharmacies). Factors related to ensuring an adequate supply of CSPs were very important to hospitals when determining whether to outsource CSPs. Also, hospitals took limited steps to ensure the quality of outsourced CSPs but had few problems with the quality of products from outside pharmacies. Finally 56 percent of hospitals made changes or planned to make changes to CSP sourcing practices in response to the fall 2012 meningitis outbreak.
RECOMMENDATIONS
This report does not contain recommendations. OIG will pursue additional work to further examine the safety and quality of pharmaceutical compounding in hospitals, including work examining Federal oversight mechanisms.
Self-Reported Hypertension and Use of Antihypertensive Medication Among Adults — United States, 2005–2009
Self-Reported Hypertension and Use of Antihypertensive Medication Among Adults — United States, 2005–2009
Source: Morbidity and Mortality Weekly Report (CDC)
Hypertension affects one third of adults in the United States (1) and is a major risk factor for heart disease and stroke (2). A previous report found differences in the prevalence of hypertension among racial/ethnic populations in the United States; blacks had a higher prevalence of hypertension, and Hispanics had the lowest use of antihypertensive medication (3). Recent variations in geographic differences in hypertension prevalence in the United States are less well known (4). To assess state-level trends in self-reported hypertension and treatment among U.S. adults, CDC analyzed 2005–2009 data from the Behavioral Risk Factor Surveillance System (BRFSS). The results indicated wide variation among states in the prevalence of self-reported diagnosed hypertension and use of antihypertensive medications. In 2009, the age-adjusted prevalence of self-reported hypertension ranged from 20.9% in Minnesota to 35.9% in Mississippi. The proportion reporting use of antihypertensive medications among those who reported hypertension ranged from 52.3% in California to 74.1% in Tennessee. From 2005 to 2009, nearly all states had an increased prevalence of self-reported hypertension, with percentage-point increases ranging from 0.2 for Virginia (from 26.9% to 27.1%) to 7.0 for Kentucky (from 27.5% to 34.5%). Overall, from 2005 to 2009, the prevalence of self-reported hypertension among U.S. adults increased from 25.8% to 28.3%. Among those reporting hypertension, the proportion using antihypertensive medications increased from 61.1% to 62.6%. Increased knowledge of the differences in self-reported prevalence of hypertension and use of antihypertensive medications by state can help in guiding programs to prevent heart disease, stroke, and other complications of uncontrolled hypertension, including those conducted by state and local public health agencies and health-care providers.
Psychological and Pharmacological Treatments for Adults With Posttraumatic Stress Disorder (PTSD)
Psychological and Pharmacological Treatments for Adults With Posttraumatic Stress Disorder (PTSD) (PDF)
Source: Agency for Healthcare Research and Quality
Several psychological and pharmacological treatments have at least moderate SOE supporting their efficacy: exposure, CPT, CT, CBT-mixed therapies, EMDR, narrative exposure therapy, fluoxetine, paroxetine, sertraline, topiramate, and venlafaxine.
First Do No Harm: Responding to Canada’s Prescription Drug Crisis
First Do No Harm: Responding to Canada’s Prescription Drug Crisis (PDF)
Source: Canadian Centre on Substance Abuse
Certain prescription drugs, like opioids, sedative – hypnotics and stimulants, are associated with serious harms like addiction, overdose and death. These drugs can have a devastating impact on individuals and their families, as well as place a significant burden on our health, social services and public safety syst ems. In countries like Canada, where these prescription drugs are readily available, the associated harms have become a leading public health and safety concern. Canada is the world’s second largest per capita consumer of one type of these drugs, opioids ( International Narcotics Control Board, 2013). Some First Nations in Canada have declared a community crisis owing to the prevalence of the harms associated with prescription drugs (Dell et al., 2012). While Canadian cost data is lacking, recent research from the United States estimates the annual cost of the non – medical use of prescription opioids to be more than $50 billion, with lost productivity and crime accounting for 94% of this amount (Hansen, Oster, Edelsberg, Woody, & Sullivan, 201 1).
Trends in High LDL Cholesterol, Cholesterol-lowering Medication Use, and Dietary Saturated-fat Intake: United St ates, 1976–2010
Source: National Center for Health Statistics
Key findings
Data from the National Health and Nutrition Examination Survey, 1976–1980, 1988–1994, 2001–2004, and 2007–2010
For adults aged 40–74:
- The prevalence of high low-density lipoprotein cholesterol, or LDL–C, decreased from 59% to 27% from the late 1970s through 2007–2010.
- The percentage of adults using cholesterol-lowering medication increased from 5% to 23% from the late 1980s through 2007–2010.
- The percentage of adults consuming a diet low in saturated fat increased from 25% to 41% from the late 1970s through 1988–1994.
- No significant changes in the percentage of adults consuming a diet low in saturated fat were observed from 1988–1994 through 2007–2010.
Each year, more than 2 million Americans suffer from acute cardiovascular events that account for approximately one-fourth of the total cost of inpatient hospital care (1). Control of low-density lipoprotein cholesterol (LDL–C) has been shown to substantially reduce cardiovascular disease morbidity and mortality (2). High LDL–C is LDL cholesterol above the treatment goals established by the National Cholesterol Education Program’s Adult Treatment Panel III guidelines. It can be managed with lifestyle changes, medications, or a combination of these approaches (3). A diet low in saturated fat is recognized as one of the most effective lifestyle changes to decrease high LDL–C (4). This report evaluates the trends in high LDL–C, use of cholesterol-lowering medication, and low dietary saturated-fat intake from 1976–1980 through 2007–2010 among adults aged 40–74.
Placebo Use in the United Kingdom: Results from a National Survey of Primary Care Practitioners
Placebo Use in the United Kingdom: Results from a National Survey of Primary Care Practitioners
Source: PLoS ONE
Objectives
Surveys in various countries suggest 17% to 80% of doctors prescribe ‘placebos’ in routine practice, but prevalence of placebo use in UK primary care is unknown.
Methods
We administered a web-based questionnaire to a representative sample of UK general practitioners. Following surveys conducted in other countries we divided placebos into ‘pure’ and ‘impure’. ‘Impure’ placebos are interventions with clear efficacy for certain conditions but are prescribed for ailments where their efficacy is unknown, such as antibiotics for suspected viral infections. ‘Pure’ placebos are interventions such as sugar pills or saline injections without direct pharmacologically active ingredients for the condition being treated. We initiated the survey in April 2012. Two reminders were sent and electronic data collection closed after 4 weeks.
Results
We surveyed 1715 general practitioners and 783 (46%) completed our questionnaire. Our respondents were similar to those of all registered UK doctors suggesting our results are generalizable. 12% (95% CI 10 to 15) of respondents used pure placebos while 97% (95% CI 96 to 98) used impure placebos at least once in their career. 1% of respondents used pure placebos, and 77% (95% CI 74 to 79) used impure placebos at least once per week. Most (66% for pure, 84% for impure) respondents stated placebos were ethical in some circumstances.
Conclusion and implications
Placebo use is common in primary care but questions remain about their benefits, harms, costs, and whether they can be delivered ethically. Further research is required to investigate ethically acceptable and cost-effective placebo interventions.
See: 97 Percent of UK Doctors Have Given Placebos to Patients at Least Once (Science Daily)
Countering the Problem of Falsified and Substandard Drugs
Countering the Problem of Falsified and Substandard Drugs
Source: Institute of Medicine
Falsified and substandard medicines provide little protection from disease and, worse, can expose consumers to major harm. Bad drugs pose potential threats around the world, but the nature of the risk varies by country, with higher risk in countries with minimal or non-existent regulatory oversight. While developed countries are not immune, – negligent production at a Massachusetts compounding pharmacy killed 44 people from September 2012 to January 2013 – the vast majority of problems occur in developing countries where underpowered and unsafe medicines affect millions.
It is difficult to measure the public health burden of falsified and substandard drugs, the number of deaths they cause, or the amount of time and money wasted using them. The FDA asked the IOM to assess the global public health implications of falsified, substandard, and counterfeit pharmaceuticals to help jumpstart international discourse about this problem. At the international level, productive discussion relies on cooperation and mutual trust. This report lays out a plan to invest in quality to improve public health.
Follow up of patients who start treatment with antidepressants: treatment satisfaction, treatment compliance, efficacy and safety
Source: BMC Psychiatry
Background
Measuring satisfaction with treatment has proved useful to ascertain the treatment features that are most important to the patients, and to explain increased treatment compliance. However, there are few studies that relate satisfaction to other clinical or self-perceived health status indicators. Recent studies have shown the close relationship between satisfaction with treatment, treatment compliance, and effectiveness. This study attempts to design and validate a scale to evaluate satisfaction with antidepressant drug therapy, assess treatment compliance (self-reported, validated questionnaire, drug accountability and electronic monitorization system), assess efficacy in reducing depressive symptoms and safety in patients who initiate antidepressant drug therapy, as well as to establish predictors of satisfaction, compliance and effectiveness with these drugs.
Methods
This is an observational longitudinal study with a cohort of adults initiating treatment with antidepressant drugs. A multi-centre study will be performed in which 20 Primary Care practices from Castilla-La Mancha are expected to participate. An initial interview and follow-up visits at 15 days, 1, 3, 6, 9 and 12 months will be conducted with all study participants. 706 subjects will be studied (95% confidence interval, precision +/- 3%, expected rate of non-compliance 50%, expected non-responders and lost to follow up rate 15%). The following measurements will be performed: development and validation of a scale of satisfaction with antidepressant therapy, participant and antidepressant characteristics, treatment compliance evaluation (Haynes-Sackett Test, Morisky-Green Test, drug accountability and Medication Event Monitoring System), depression symptom reduction (Hamilton Depression Rating Scale and Montgomery-Asberg Depression Rating Scale), observation of adverse effects, and beliefs about treatment (The Beliefs about Medicines Questionnaire).
Discussion
Antidepressant drugs are an extraordinarily important therapeutic group in the pharmacy composition; economic repercussions and social impact associated to their use is clear. Despite their well-established efficacy in clinical trials, treatment non-compliance is a major obstacle to their effectiveness in clinical practice. The proposed study brings about useful conclusions to improve the results of these drugs. Additionally, devising a scale specifically designed to evaluate satisfaction with antidepressant treatment could be of interest in healthcare outcomes research.
New From the GAO
New GAO Reports
Source: Government Accountability Office
Broadcast and Cable Television
Requirements for Identifying Sponsored Programming Should Be Clarified
GAO-13-237, Jan 31, 2013
Defense Logistics
A Completed Comprehensive Strategy is Needed to Guide DOD’s In-Transit Visibility Efforts
GAO-13-201, Feb 28, 2013
Department Of Justice
Executives’ Use of Aircraft for Nonmission Purposes
GAO-13-235, Feb 26, 2013
Homeland Defense
DOD’s Aerospace Control Alert Basing Decision Was Informed by Various Analyses
GAO-13-230R, Feb 28, 2013
Prescription Drugs
The Number, Role, and Ownership of Pharmacy Services Administrative Organizations
GAO-13-176, Jan 29, 2013
Temporary Assistance for Needy Families
Workforce Participation Requirement Waivers
GAO-13-423T, Feb 28, 2013
CRS — Pharmaceutical Patent Settlements: Issues in Innovation and Competitiveness
Pharmaceutical Patent Settlements: Issues in Innovation and Competitiveness (PDF)
Source: Congressional Research Service (via Federation of American Scientists)
Although brand-name pharmaceutical companies routinely procure patents on their innovative medications, such rights are not self-enforcing. Brand-name firms that wish to enforce their patents against generic competitors must therefore commence litigation in the federal courts. Such litigation ordinarily terminates in either a judgment of infringement, which typically blocks generic competition until such time as the patent expires, or a judgment that the patent is invalid or not infringed, which typically opens the market to generic entry.
As with other sorts of commercial litigation, however, the parties to pharmaceutical patent litigation may choose to settle their case. Certain of these settlements have called for the generic firm to neither challenge the brand-name company’s patents nor sell a generic version of the patented drug for a period of time. In exchange, the brand-name drug company agrees to compensate the generic firm, often with substantial monetary payments over a number of years. Because the payment flows counterintuitively, from the patent owner to the accused infringer, this compensation has been termed a “reverse” payment.
Commentators have differed markedly in their views of reverse payment settlements. Some observers believe that they are a consequence of the specialized patent litigation procedures established by the Hatch-Waxman Act. Others have concluded that when one competitor pays another not to market its product, such a settlement is anti-competitive and a violation of the antitrust laws.
Since 2003, Congress has required that litigants notify federal antitrust authorities of their pharmaceutical patent settlements. That legislation did not dictate substantive standards for assessing the validity of these agreements under the antitrust law, however. That determination was left to judicial application of general antitrust principles. Facing different factual patterns, some courts have concluded that a particular reverse payment settlement constituted an antitrust violation, while others have upheld the agreement. The Supreme Court agreed to hear a reverse payment settlement case, Federal Trade Commission v. Watson Pharmaceuticals, Inc., on December 7, 2012, and may possibly issue a ruling that provides a nationally uniform judicial approach to these agreements.
Congress possesses a number of alternatives for addressing reverse payment settlements. One possibility is to await further judicial developments. Another option is to regulate the settlement of pharmaceutical patent litigation in some manner. For example, one unenacted proposal from the 112 th Congress, H.R. 3995, would have declared that certain reverse payment settlements violate the antitrust laws. Another possibility, proposed by S. 27 in the 112 th Congress but not enacted, would establish a presumption of either legality or illegality under the antitrust laws, along with consideration of relevant factors to be weighed by the courts. Still another unenacted proposal from the 112 th Congress, S. 1882, would have introduced reforms to the food and drug laws that would have reduced incentives for generic firms to settle with brand-name companies. Any of these, or other proposals, may be revisited by policymakers during the 113 th Congress.
State Estimates of Nonmedical Use of Prescription Pain Relievers
State Estimates of Nonmedical Use of Prescription Pain Relievers
Source: Substance Abuse and Mental Health Services Administration
- Combined 2010 and 2011 data indicate that the rate of past year nonmedical use of prescription pain relievers among those aged 12 or older was 4.6 percent nationally and ranged from 3.6 percent in Iowa to 6.4 percent in Oregon
- Of the 10 States with the highest rates of past year nonmedical use of prescription pain relievers in 2010 and 2011, 7 were in the West region; of the 10 States with the lowest rates, 4 were in the Midwest region, and 4 were in the Southern region
- Comparisons of combined 2009 and 2010 data with combined 2010 and 2011 data showed that past year nonmedical use of prescription pain relievers among persons aged 12 or older decreased in 10 States (Kentucky, Louisiana, Massachusetts, Mississippi, New Hampshire, New York, Ohio, Oklahoma, Rhode Island, and West Virginia), and did not increase in any State
Psychotropic Medication Use Among Children in the Child Welfare System
Psychotropic Medication Use Among Children in the Child Welfare System (PDF)
Source: Carsey Institute
Key Findings
- Among children age 4 and older with a report of maltreatment, rates of psychotropic medication use are significantly higher in rural (20 percent) than urban areas (13 percent).
- Children age 4 and older with a maltreatment report in rural areas were significantly more likely to take more than one medication than children in urban areas. In rural places, 28 percent took two medications and 33 percent took three or more medications. In urban places, 23 percent took two and 14 percent took three or more medications.
- In addition to emotional or behavioral problems, a number of other factors predicted which children were given psychotropic medication, including whether they receive counseling, being 12 years old or older, and being male.
- In rural places, children living in poor households were more likely to be given psychotropic medication.
- Twenty percent of children in rural areas with a child maltreatment report who remain in-home received medication compared to 12 percent in urban areas.
State Estimates of Nonmedical Use of Prescription Pain Relievers
State Estimates of Nonmedical Use of Prescription Pain Relievers
Source: Substance Abuse and Mental Health Services Administration
- Combined 2010 and 2011 data indicate that the rate of past year nonmedical use of prescription pain relievers among those aged 12 or older was 4.6 percent nationally and ranged from 3.6 percent in Iowa to 6.4 percent in Oregon
- Of the 10 States with the highest rates of past year nonmedical use of prescription pain relievers in 2010 and 2011, 7 were in the West region; of the 10 States with the lowest rates, 4 were in the Midwest region, and 4 were in the Southern region
- Comparisons of combined 2009 and 2010 data with combined 2010 and 2011 data showed that past year nonmedical use of prescription pain relievers among persons aged 12 or older decreased in 10 States (Kentucky, Louisiana, Massachusetts, Mississippi, New Hampshire, New York, Ohio, Oklahoma, Rhode Island, and West Virginia), and did not increase in any State
FDA requiring lower recommended dose for certain sleep drugs containing zolpidem
FDA requiring lower recommended dose for certain sleep drugs containing zolpidem
Source: U.S. Food and Drug Administration
The U.S. Food and Drug Administration today announced it is requiring the manufacturers of Ambien, Ambien CR, Edluar and Zolpimist, widely used sleep drugs that contain the active ingredient zolpidem, to lower current recommended doses. Ambien and Ambien CR are also available as generics. New data show that zolpidem blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving.
Using lower doses of zolpidem means less of the drug will remain in the blood in the morning hours. Since women eliminate zolpidem from their bodies more slowly than men, the FDA has notified the manufacturers that the recommended dose should be lowered for women and that the labeling should recommend that health care professionals consider a lower dose for men. Data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs. The FDA urges health care professionals to caution all patients (men and women) who use these products about the risks of next-morning impairment for activities that require complete mental alertness, including driving.
The FDA has informed the manufacturers that the recommended dosage of zolpidem for women should be lowered from 10 milligrams (mg) to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). For men, the FDA has informed the manufacturers that the labeling should recommend that health care professionals consider prescribing these lower doses (5 mg for immediate-release products and 6.25 mg for extended-release products). These products are currently available on the market in both the higher and lower dosages.
