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Disease Knowledge Centres

Sleep Medicine - Disease Topic Overview

Sleep medicine is a specialty or subspecialty devoted to the diagnosis and treatment of sleep disturbances and disorders. From the middle of the 20th century, research has provided increased knowledge about the circadian rhythm, and has answered many questions surrounding the impact of sleep, or lack of it.¹

Sleep represents more than a third of life, however, the sustained rhythms of life imposed by society unsettle and affect sleep; through stress, jet-lag, and shift work.²

Sleep is an essential component of life, and the diseases that affect sleep (insomnia, narcolepsy, restless legs syndrome, sleep apnoea) have a significant impact on one’s health², social life², academic³ and professional life⁴. The prevalence of sleep disorders increases with age, and can have a significant impact on a person’s overall health.⁵

Some diseases exclusively related to sleep can cause insomnia:
- Restless legs syndrome is a condition which causes very unpleasant sensations in the legs that require one to stand and to move.⁶ It typically presents itself in the evening, causing disrupted sleep which in turn affects quality of life.⁶
- Sleep apnoea, characterised by abnormal pauses in breathing (ranging from seconds to minutes), indicates a struggle to breathe and result in disturbed and fragmented sleep.⁷

Other sleep disorders are often secondary to chronic diseases such as fibromyalgia⁸, Parkinson's disease⁹, Alzheimer’s disease¹⁰ and various types of cancer.¹¹ All these disorders and sleep disturbances are common and can have significant consequences for affected individuals, as well as economic consequences for society (through absenteeism or accident).⁴ Sleep (or lack of it) is therefore a major public health issue.

1. Morgenthaler T. I. et al. Practice parameters for the clinical evaluation and treatment of circadian rhythm sleep disorders. Sleep. November 2007 ; 1 (30) : 1445-59.
2. Bixler E. Sleep and society: An epidemiological perspective. Sleep Medicine. September 2009 ; 10 (1) : S3-S6.
3. Curcio G. et al. Sleep loss, learning capacity and academic performance. Sleep Medicine Reviews. October 2006 ; 10 (5) : 323-337.
4. Léger D. Economical consequences from sleep disorders and its impact on the quality of life. Médecine du Sommeil. December 2008 ; 5 (18) : 19-23.
5. Phillips B. et al. Sleep disorders in the elderly. Sleep Medicine. March 2001 ; 2 (2) : 99-114.
6. Hening W. A. et al. Restless legs syndrome: A common disorder in patients with rheumatologic conditions. Seminars in Arthritis and Rheumatism. August 2008 ; 38 (1) : 55-62.
7. Banno K. et al. Sleep apnea: Clinical investigations in humans. Sleep Medicine. June 2007 ; 8 (4) : 400-426.
8. Russell I. J. et al. The effects of pregabalin on sleep disturbance symptoms among individuals with fibromyalgia syndrome. Sleep Medicine. June 2009 ; 10 (6) : 604-610.
9. Brotini S. et al. Epidemiology and clinical features of sleep disorders in extrapyramidal disease. Sleep Medicine. March 2004 ; 5 (2) : 169-179.
10. Moran M. et al. Sleep disturbance in mild to moderate Alzheimer's disease. Sleep Medicine. July 2005 ; 6 (4) : 347-352.
11. Benezech J-P. Sleep troubles and cancer. Médecine Palliative : Soins de Support - Accompagnement - Éthique. August 2010 ; 9 (4) : 184-190.

Insomnia
Insomnia is a very common and debilitating disease with major morbidity and social consequences. Despite the negative impact on the ability to function well during the day, insomnia is underdiagnosed and undertreated. Insomnia is therefore, important to treat. However, treatment has been difficult due to concerns over current treatment options, both from a patient and physician perspective.

Various methods are used to monitor the different stages of sleep. Sleep is not homogenous – its structure, characterised by a sequence of sleep stages, is referred to as ‘sleep architecture’

Traditionally insomnia has been diagnosed on the basis of quantity of sleep
- Sleep latency (time taken to get to sleep)
- Sleep duration (length of time spent asleep)
While it is important not to ignore quantity of sleep, epidemiological surveys show that poor quality of sleep has a greater negative impact on health, well-being and satisfaction with life than the quantity of sleep a person gets.^1,2

Hormones released in the body are involved in certain aspects of homeostasis, including regulating the circadian rhythms established by the SCN of the hypothalamus. Melatonin is an endocrine hormone that is principally produced and released into the blood by the pineal gland. The levels of melatonin fluctuate according to light exposure (highest during darkness and sleep, and lowest in bright sunlight) and it is proposed that melatonin acts as a time ‘cue’, entraining the body’s circadian rhythm to conventional environmental patterns.

Although behavioural and psychological factors have been shown to play an important causative role in many sleep disorders, non-pharmacological/behavioural approaches are underused in the management of these conditions.^3,4

A number of resources for both patients and physicians are avaliable within this Insomnia website.

Enter the Insomnia Knowledge Centre

What’s in the Insomnia Knowledge Centre?
References

1. Zammit GK, Weiner J, Damato N et al. Quality of life in people with insomnia. Sleep 1999; 22 Suppl 2: S379-85
2. Pilcher JJ. Sleep quality versus sleep quantity: relationships between sleep and measures of health, well-being and sleepiness in college students. J Psychosom Res. 1997; 42(6): 583-96
3. National Institute of Health. NIH State of the Science Conference statement on manifestations and management of chronic insomnia in adults statement. J Clin Sleep Med 2005; 1 (4): 412–421.
4. Subramanian S, Surani S. Sleep disorders in the elderly. Geriatrics 2007; 62 (12): 10–32.

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Insomnia is a very common and debilitating disease with major morbidity and social consequences. Despite the negative impact on the ability to function well during the day, insomnia is underdiagnosed and undertreated.

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Latest Multi Media

An Insight into the Link Between ADHD and Sleep Disorders

Sleep Medicine Drug Data - A-Z English

Drug Updates

Amiodarone Hydrochloride 100mg Tablets

Treatment should be initiated and normally monitored only under hospital or specialist supervision.

Amiodarone Hydrochloride 200mg Tablets

Treatment should be initiated and normally monitored only under hospital or specialist supervision.

Natrasleep

A herbal remedy traditionally used to encourage natural sleep.

Latest Drug News

Pfizer will not proceed with Lyrica for Restless Legs Syndrome - 20-12-2011

Pfizer will not proceed with regulatory approval for Lyrica (pregabalin), its GABA analogue, for Restless Legs Syndrome despite reporting positive Phase III results for the drug in this patient group.

FDA approves Intermezzo (Transcept Pharmaceuticals) for use with middle-of-the-night Insomnia - 25-11-2011

The FDA has approved Intermezzo (zolpidem tartrate sublingual tablets), from Transcept Pharmaceuticals, for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep. This is the first time the FDA has approved a drug for this condition. Intermezzo should only be used when a person has at least four hours of bedtime remaining. It should not be taken if alcohol has been consumed or with any other sleep aid. Zolpidem tartrate was first approved in the United States in 1992 as the drug Ambien. Intermezzo is a lower dose formulation of zolpidem. The recommended and maximum dose of Intermezzo is 1.75 milligrams for women and 3.5 mg for men, taken once per night. The recommended dose for women is lower because women clear zolpidem from the body at a lower rate than men. The approval is based on two clinical trials involving more than 370 patients. In the studies, patients taking the drug had a shorter time to fall back asleep after waking compared to people taking an inactive pill (placebo). The most commonly reported adverse reactions in the clinical trials were headache, nausea and fatigue.

Latest Social Media

Have you ever responded to "is there a doctor in the house/on the plane?"
on doc2doc

... a couple of herbal sleeping tablets, and two brandies, then become less responsive. "Can I see these herbal sleeping tablets, then?" ...

Have you ever responded to "is there a doctor in the house/on the plane?"
on doc2doc

... more like a GP problem (he told me he was a GP) than thoracic, ICU or sleep. I returned to my seat. He fixed the man. This has never happened again ...

Truck Drivers, obesity and sleep apnoea.
on doc2doc

... and sleep apnoea. Thank you Odysseus, for bringing this up here. I think it is like hitting nail-bed of the frontiers of sleep research while we ...

Latest Clinical Trials

Mindfulness-Based Approaches to Insomnia

The overall goal of this project is to evaluate the evidence for the efficacy of two mindfulness-based interventions, mindfulness-based therapy for insomnia (MBT-I) and mindfulness-based stress reduction (MBSR), for reducing arousal and improving sleep among individuals with psychophysiological insomnia. Specific Aim 1: To obtain evidence for the relative effects of MBT-I and MBSR compared to a delayed-treatment control condition followed by behavior therapy for insomnia (BT-I) on arousal levels. It is hypothesized that MBSR and MBT-I will be superior to the control condition at reducing arousal levels. Specific Aim 2: To obtain evidence for the relative effects of MBT-I, MBSR, and the delayed-treatment control on sleep. It is hypothesized that MBT-I will be superior to the MBSR and control conditions at improving sleep parameters. Specific Aim 3: To investigate the relationship between measures of arousal (self-report and objective measures) and sleep (self-report and objective measures) to enhance the understanding of the role of arousal in psychophysiological insomnia.

Acupuncture for the Treatment of Insomnia

Insomnia is a common and disabling condition associated with psychiatric and medical comorbidities and often persists despite currently available treatments. Acupuncture has been reported to benefit individuals with insomnia and can decrease hyperarousal. This blinded RCT will investigate the impact of a standardized acupuncture protocol on insomnia, daytime symptoms, and hyperarousal.

Latest Journal Publications

Journal of Affective Disorders

Background: Few studies have prospectively examined the relationships of sleep with symptoms and functioning in bipolar disorder. Methods: The present study examined concurrent and prospective associations between total sleep time (TST) and sleep variability (SV) with symptom severity and functioning in a cohort of DSM-IV bipolar patients (N = 468) participating in the National Institute of Mental Health Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD), all of whom were recovered at study entry. Results: Concurrent associations at study entry indicated that shorter TST was associated with increased mania severity, and greater SV was associated with increased mania and depression severity. Mixed-effects regression modeling was used to examine prospective associations in the 196 patients for whom follow-up data were available. Consistent with findings at study entry, shorter TST was associated with increased mania severity, and greater SV was associated with increased mania and depression severity over 12 months. Discussion: These findings highlight the importance of disrupted sleep patterns in the course of bipolar illness.

Stroke research and treatment

Background. Fatigue after stroke is common and distressing to patients. Aims. Our aims were to explore patients' perceptions of post-stroke fatigue, including the causes of fatigue and the factors that alleviate fatigue, in a mixed methods study. Results. We interviewed 15 patients who had had a stroke and were inpatients on stroke rehabilitation wards. A substantial proportion of patients reported that their fatigue started at the time of their stroke. Various different factors were reported to improve fatigue, including exercise, good sleep, rehabilitation and rest. Fatigue influences patients' sense of “control” after their stroke. Conclusion. Our results are consistent with the possibility that poststroke fatigue might be triggered by factors that occur at the time of the stroke (e.g., the stroke lesion itself, or admission to hospital) and then exacerbated by poor sleep and boredom. These factors should be considered when developing complex interventions to improve post-stroke fatigue.

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Somaxon may head for OTC status in USA for Insomnia Sleep Medicine Page

Somaxon Pharmaceuticals is likely to seek regulatory approval in the USA for an over-the-counter version of Silenor (low dose doxepin). A recent meeting at the FDA seemed positive. The marketing of Silenor with Proctor & Gamble launched 12 months ago has not been successful due to low cost competition from generic versions of Ambien and Ambien CR (extended-release zolpidem).Somaxon plans to discontinue the co-promotion services of Proctor & Gamble at the end of this year but is interested in discussing marketing of the OTC version with Proctor & Gamble. The OTC version launch maybe still several years away. Somaxon is also facing generic challenges to the drug.Paladin Labs has rights in Canada, Latin America and Africa.

FDA to review re-submitted Intermezzo in November 2011 for Insomnia Sleep Medicine Page

Transcept Pharma had resubmitted its drug application for its middle-of-the-night insomnia drug Intermezzo (zolpidem tartrate sublingual tablet) in January 2011. The drug had failed to win approval in October 2009. The FDA sent out a Complete Response Letter regarding the resubmitted New Drug Application. In it, the FDA stated that it cannot conclude that Intermezzo can be used safely based on the information in the NDA. The proposed label for Intermezzo indicates that the drug should only be taken when patients have at least four hours of bedtime remaining before being active again. The FDA suggests further investigations of whether body weight and demographic factors contribute to differentially elevated blood levels the morning after dosing Intermezzo, develop strategies to decrease next-morning zolpidem levels, and, after mitigation strategies are implemented, demonstrate that next-morning blood levels do not present an unacceptable risk of next-day impairment, which may include the conduct of an additional driving study. Transcept Pharma has again resubmitted an NDA for Intermezzo with the results of a positive driving study and following a meeting the FDA has accepted the NDA and classified it as a Class 1 response, setting a decision date of 27 November 2011

Takeda discontinues Rozerem for Insomnia in the EU Sleep Medicine Page

Takeda discontinues the development of Rozerem (ramelteon)the MT1 and MT2 receptor agonist for Insomnia in the EU following the withdrawal of its application for approval after a negative opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).