Insomnia: Zolpidem Extended-Release for the Treatment of Sleep Induction and Sleep Maintenance Symptoms

Paul P. Doghramji, MD, FAAFP


January 17, 2007


Insomnia symptom presentation includes difficulty initiating sleep, difficulty maintaining sleep, or waking too early without being able to return to sleep,[1] causing clinically significant daytime distress or functional impairment in social, occupational, and/or other important areas of functioning.[2] When it becomes chronic, insomnia has the potential to develop into more serious conditions; for example, studies have demonstrated that insomnia patients may be at an increased risk for cardiac morbidity, ischemic stroke,[3] glucose intolerance, weight gain, and psychiatric disturbances.[4,5] Patients may also experience overall reductions in quality of life, cognitive and occupational functioning, and incur excess healthcare utilization.[6,7,8]

Comorbidities that exist with insomnia are often bidirectional: Not only does insomnia increase the odds of developing psychiatric and medical problems, but the latter two can increase the likelihood of insomnia.[9] In addition, major depression, anxiety disorders, chronic pain, stress, grief, medication side effects, alcohol consumption, noise, and poor sleeping environment are seen more often in patients with insomnia. In patients with depression, sleep problems may appear months before the diagnosis of clinical depression and persist after the resolution of depression; emerging evidence indicates that managing insomnia symptoms may augment the treatment of this comorbid disease.[10,11] Therefore, it behooves the clinician to investigate the sleep habits of patients as a matter of routine.

Patients often do not volunteer information with regard to their sleep disturbances with their physicians, even though surveys of primary care patients consistently report that the majority of patients experience some form of sleep difficulty.[12] This may be due to the fact that insomnia is often viewed by patients as a bad habit that they should be able to remedy on their own, and the perception that insomnia has no serious causes or consequences. Moreover, insomnia underrecognition is further promoted by physicians' reluctance to inquire about their patients' sleep habits. This is, for the most part, due to a lack of specific insomnia knowledge among primary care physicians.[13] Hence, continuing education of physicians and patients on insomnia and currently available therapies is essential for best practice. This should lead to more inquiries about patients' sleep situations and habits in the primary care setting, particularly in instances in which sleep problems could exist, ie, in the acute setting, in follow-up visits for chronic problems, and during complete medical evaluation.

Over-the-counter antihistamines, herbal products, and self-medication with alcohol are common methods used by patients suffering from insomnia, regardless of problems with safety and a lack of proven efficacy for these agents in insomnia.[1] Although some patients visit their clinicians after failing with these treatments, the majority do not, and may continue to self-medicate ineffectively for long periods of time, only presenting to a clinician when their condition has become chronic.[14]

Patients often suffer from more than 1 insomnia symptom (ie, difficulty falling asleep, staying asleep, or awaking too early), the variability and intensity of which can evolve unpredictably over time.[15,16] Therefore, it may be important to consider the efficacy for sleep onset as well as sleep maintenance, when selecting a sleep medication. However, many current treatment options (such as zaleplon [Sonata] and zolpidem [Ambien]) only have efficacy for sleep-onset difficulties. A modified-release formulation of zolpidem tartrate, zolpidem extended-release (Ambien CR; also referred to as zolpidem modified-release in previous literature), is approved for the treatment of insomnia associated with sleep-onset and/or sleep maintenance difficulties, with the potential to provide clinical benefits beyond that of the original immediate-release formulation of zolpidem. An overview of the data supporting the use of zolpidem extended-release for the management of insomnia is presented here. In particular, efficacy in promoting both sleep onset and sleep maintenance is described in both healthy volunteers and adult and elderly patients with chronic primary insomnia.


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