by Elisa Cascade; Amir H. Kalali, MD; and Timothy Roehrs, PhD
Ms. Cascade is Vice President, Quintiles Inc./iGuard, Falls Church, Virginia; Dr. Kalali is Vice President, Global Therapeutic Group Leader CNS, Quintiles Inc., San Diego, California, and Professor of Psychiatry, University of California, San Diego; and Dr. Roehrs is Director of Research at the Sleep Disorders Center, Henry Ford Hospital and
Professor, Department of Psychiatry and Behavioral Neuroscience, School of Medicine, Wayne State University, Detroit, Michigan.
Psychiatry (Edgemont) 2009;6(5):16–19
Financial Disclosure: Dr. Roehrs has been consultant to Sanofi Pharmaceuticals and Evotec Pharmaceuticals.
Key words: sleep aid, insomnia, primary care physician, psychiatrist, zolpidem, eszipiclone
Abstract
In this article, we highlight trends in current use of sleep aids and examine similarities/ differences in product use by primary care physicians and psychiatrists. From 2006 to 2008, total prescriptions for sleep aids increased 21.1 percent overall and 23.2 percent for primary care physicians and 20.2 percent for psychiatrists in particular. Since generic availability of zolpidem, the market share for the molecule has increased from 42 percent to 57 percent, likely due to payer and patient demand for lower cost alternatives. While zolpidem share is similar between primary care physicians and psychiatrists, reasons for product use differ: 85 percent of sleep aids used by primary care physicians are for the treatment of patients with a primary diagnosis of insomnia, whereas 79 percent sleep aids used by psychiatrists are for the treatment of insomnia secondary to another central nervous system (CNS) condition.
INTRODUCTION
Sleep aids, such as generic zolpidem, Ambien® CR (zolpidem extended release), and Lunesta® (eszipiclone), are commonly used by primary care physicians and psychiatrists to treat insomnia. In this article, we highlight trends in current use of sleep aids and examine similarities/differences in product use by primary care physicians and psychiatrists.
METHODS
We examined quarterly prescription data from SDI/Verispan’s Vector One National (VONA) database from 2006 to 2008. SDI/Verispan’s VONA captures nearly half of all prescription activity in the US. Data on reasons for product use was obtained from SDI/Verispan’s Prescription Drug and Diagnosis Audit (PDDA) database from January 2008 to December 2008 for patients treated with sleep aids. PDDA captures data on disease state and associated therapy from 3,100 office-based physicians representing 29 specialties across the United States.
RESULTS
Over the past two years, total prescriptions for sleep aids have increased both overall and for primary care physicians and psychiatrists in particular (Figure 1). The overall rate of increase in the market was 21.1 percent. The rate of increase in primary care (23.2%) was higher than the overall market rate, while the increase in psychiatry (20.2%) was slightly lower.
Figure 2 displays the market share of Ambien/generic zolpidem. As seen in Figure 2, in Quarter 1 of 2006 (Q106), Ambien represented 48.9 percent of all prescription sleep aid use. Ambien’s market share decreased until generic zolpidem became available in Quarter 2 of 2007 (Q207) (primarily due to a shift of promotional resources away from Ambien to Ambien CR). Since generic availability, the market share of zolpidem has increased from 42 to 57 percent. Although in some CNS therapy areas it is unusual to see an increase in product market share following generic launch, this is not the case for the sleep aid market where payers and patients were seeking lower cost alternatives.
While zolpidem share is similar between primary care physicians and psychiatrists, reasons for product use differ. Eighty-five percent of sleep aids used by primary care physicians are for the treatment of patients with a primary diagnosis of insomnia as compared to 17 percent of psychiatry use. Psychiatrists, however, more commonly use sleep aids as a treatment of insomnia secondary to another CNS condition (79% of uses).
EXPERT COMMENTARY
by Dr. Timothy Roehrs
These data on trends in the use of sleep aids from 2006 to 2008 are not unexpected. The 21-percent increase over these last two years can be attributed to several factors. In 2005, a State of the Science Insomnia Conference convened by the NIH issued a consensus statement.[1] The consensus statement represented a paradigm shift in our understanding of insomnia. The identification of primary insomnia as a chronic disorder with clear morbidity and its own pathophysiology that requires treatment was acknowledged in the consensus statement. Over the same period, results from double-blind, placebo-controlled trials of nightly use for six months and longer showed continued hypnotic efficacy with little increase in safety concerns.[2] This information was widely disseminated to primary care physicians and psychiatrists through CME courses throughout the US.
Coinciding with the paradigm shift was the introduction to the market of several new FDA-approved hypnotics, including eszopiclone, zolpidem CR, and remelteon. Each of these hypnotics was aggressively advertised in direct-to-consumer television advertisements. This likely raised consumer attention and recognition of insomnia and offered a potential treatment, which patients likely discussed with their physicians. Pre-2005 survey data indicated that a very small percentage of patients with insomnia had discussed their sleep problems with their physicians.[3] I am not aware of post-2005 data that indicate patient awareness has increased, but the media is likely to have had an impact on patient awareness.
The 21-percent increase in use of sleep aids raises the question as to whether this reflects best medical practice. The epidemiologic evidence indicates that 10 to 13 percent of the population suffers from chronic insomnia and it does not resolve spontaneously. For half of those with chronic insomnia, it can persist for 2 to 6 years.[4] Furthermore, the morbidity of untreated and self-treated insomnia is now recognized. Insomnia impairs work and social functioning, exacerbates other medical disorders, and is predictive of new-onset depression and relapse. Many of the self-treatments either have limited effectiveness (i.e., over-the-counter medications) or are risky (i.e., alcohol used as a sleep aid).[5] The new nonbenzodiazepine hypnotics have improved safety profiles compared to the alternatives of nontreatment or treatment with drugs without a hypnotic indication.[5]
The differential reason for prescribing between primary care physicians and psychiatrists is reassuring. Primary insomnia is conceptualized as sleep disturbance not arising from another primary sleep disorder or medical, psychiatric, circadian, behavioral, or pharmacologic cause. It is appropriate that the primary care physician treat the sleep disturbance. On the other hand, insomnia is a prominent symptom associated with depression and anxiety disorders. Many of the psychiatric medications are sedating and improve insomnia. This may explain the slightly smaller increase in hypnotic prescribing by psychiatrists. But, some of the psychiatric drugs are alerting and exacerbate insomnia. Adjunctive treatment with hypnotics has been shown to improve insomnia associated with depression or anxiety disorders and, in some cases, hasten recovery from the psychiatric disorder.[6]
References
1. National Institutes of Health State of the Science Conference Statement. Manifestations and management of chronic insomnia in adults June 13–15, 2005. Sleep. 2005;28:1049–1057.
2. Walsh JK, Roehrs T, Roth T. Pharmacologic treatment of primary insomnia. In: Kryger MH, Roth T, Dement WC (eds). Principles and Practice of Sleep Medicine, Fourth Edition. Philadelphia: Elsevier Saunders, 2005:749–760.
3. Ancoli-Israel S, Roth T. Characteristics of insomnia in the United States: results of the 1991 National Sleep Foundation Survey. Sleep. 1999;22:S347–353.
4. Roth T, Roehrs T, Pies R. Insomnia: pathophysiology and implications. Sleep Med Rev. 2007;11:71–79.
5. Roehrs T, Roth T. Safety of insomnia pharmacotherapy. Sleep Med Clinics. 2006;1:399–407.
6. Pollack M, Kinrys G, Krystal A, et al. Eszopiclone coadministered with escitalopram in patients with insomnia and comorbid generalized anxiety disorder. Arch Gen Psychiatry. 2008;65:551–562.
