H. Heith Durrence

Quantitative criteria for insomnia

Formal diagnostic systems (DSM-IV, ICSD, and ICD-10) do not provide adequate quantitative criteria to diagnose insomnia. This may not present a serious problem in clinical settings where extensive interviews determine the need for clinical management. However, lack of standard criteria introduce disruptive variability into the insomnia research domain. The present study reviewed two decades of psychology clinical trials for insomnia to determine common practice with regard to frequency, severity, and duration criteria for insomnia. Modal patterns established frequency (> or =3 nights a week) and duration (> or =6 months) standard criteria. We then applied four versions of severity criteria to a random sample and used sensitivity-specificity analyses to identify the most valid criterion. We found that severity of sleep onset latency or wake time after sleep onset of: (a) > or =31 min; (b) occurring > or =3 nights a week; (c) for > or =6 months are the most defensible quantitative criteria for insomnia.

Insomnia as a health risk factor

This article reviewed insomnia epidemiological research, identifying areas where insomnia was a risk factor and isolating areas deserving of further investigation. Insomnia was consistently predictive of depression, anxiety disorders, other psychological disorders, alcohol abuse or dependence, drug abuse or dependence, and suicide, indicating insomnia is a risk factor for these difficulties. Additionally, insomnia was related to decreased immune functioning. The data were inconclusive regarding insomnia as a risk factor for cardiovascular disease and mortality, but sleep medication use was predictive of mortality. These results must be tempered with the knowledge that significant weaknesses existed in the studies reviewed. The main weaknesses were inadequate definition of insomnia and inadequate control for alternative explanations. Despite these limitations, this review suggests that insomnia is a risk factor for poor mental and physical health.

Sleep and quality of life in breast cancer patients.

This study described sleep in a heterogeneous sample of breast cancer patients using the Pittsburgh Sleep Quality Index (PSQI) and examined the relation between sleep disturbance and health-related quality of life as measured by the Rand 36-Item Health Survey. Chemotherapy and radiation therapy were explored as predictors of sleep disturbance in breast cancer patients, and the sleep characteristics of breast cancer patients were compared to the sleep characteristics of a sample of medical patients with general medical conditions. Results showed that 61% of breast cancer patients had significant sleep problems. Sleep was characterized by reduced total sleep time with sleep frequently being disturbed by pain, nocturia, feeling too hot, and coughing or snoring loudly. Despite the frequency of significant sleep disturbance, pharmacological and cognitive-behavioral treatments of sleep problems were observed to be inadequate. Limited evidence was found for the role of chemotherapy and radiation therapy in the sleep disturbance of breast cancer patients, and the general pattern of sleep disturbance in breast cancer patients was not significantly different than that observed in medical patients with general medical conditions. Breast cancer patients having significant sleep problems had greater deficits in many areas of health-related quality of life. The implications of the findings and study limitations are discussed.

The Sleep of African Americans: A Comparative Review

Researchers have not thoroughly assessed the sleep of African Americans (AAs) despite the recent increased attention to ethnic research. This article reviews the sleep and epidemiological literatures to assess AA sleep. Although the limited data were sometimes inconsistent, they suggest that AAs sleep worse than Caucasian Americans. AAs take longer to fall asleep, report poorer sleep quality, have more light and less deep sleep, and nap more often and longer. AAs have a higher prevalence of sleep-disordered breathing and exhibit more risk factors for poor sleep. These differences are concentrated in young- and middle-age adults. There are no sleep disorders treatment data for AAs. These data support further research into ethnic differences in both normal and disturbed sleep.

Epidemiology of Sleep : Age, Gender, and Ethnicity

Contents: Goals and Distinctive Characteristics of This Survey. A Review of Epidemiological Studies of Insomnia and Sleep. Methods of This Survey. An Archive of Normal Sleep. An Archive of Insomnia. An Archive of the Sleep of African Americans. Summary of Main Findings. Appendix: Alphabetical Listing of Abbreviations and Acronyms.

Socioeconomic status and insomnia

This investigation compared the likelihood of insomnia and insomnia-related health consequences among individuals of different socioeconomic status. A random-digit dialing procedure was used to recruit at least 50 men and 50 women in each age decade from 20 to 80+ years old. Participants completed 2 weeks of sleep diaries as well as questionnaires related to fatigue, sleepiness, and psychological distress. Socioeconomic status was measured by education status assessed at 3 different levels: individual, household, and community. Results indicated that individuals of lower individual and household education were significantly more likely to experience insomnia even after researchers accounted for ethnicity, gender, and age. Additionally, individuals with fewer years of education, particularly those who had dropped out of high school, experienced greater subjective impairment because of their insomnia.

Efficacy and Safety of Doxepin 3 and 6 mg in a 35-day Sleep Laboratory Trial in Adults with Chronic Primary Insomnia

STUDY OBJECTIVES To evaluate the efficacy and safety of doxepin (DXP) 3 mg and 6 mg in adults diagnosed with primary insomnia. DESIGN AND METHODS The study was a randomized, double-blind, parallel-group, placebo-controlled trial. Patients meeting DSM-IV-TR criteria for primary insomnia were randomized to 35 days of nightly treatment with DXP 3 mg (n=75), DXP 6 mg (n=73), or placebo (PBO; n=73), followed by 2 nights of single-blind PBO to evaluate discontinuation (DC) effects. Efficacy was assessed using polysomnography (PSG) and patient reports. Efficacy data were examined for Night (N) 1, N15, and N29. Safety assessments were conducted throughout the study. RESULTS Compared with PBO, DXP 3 and 6 mg significantly improved wake time after sleep onset (WASO) on N1 (3 mg and 6 mg; P<0.0001), N15 (3 mg P=0.0025; 6 mg P=0.0009), and N29 (3 mg P=0.0248; 6 mg P=0.0009), latency to persistent sleep (LPS) on N1 (3 mg P=0.0047; 6 mg P=0.0007), and total sleep time (TST) on N1 (3 mg and 6 mg P<0.0001), N15 (6 mg P=0.0035), and N29 (3 mg P=0.0261; 6 mg P<0.0001). In terms of early morning awakenings, DXP 3 and 6 mg demonstrated significant improvements in SE in the final quarter of the night on N1, N15, and N29, with the exception of 3 mg on N29 (P=0.0691). Rates of discontinuation were low, and the safety profiles were comparable across the 3 treatment groups. There were no significant next-day residual effects, and there were no spontaneous reports of memory impairment, complex sleep behaviors, anticholinergic effects, weight gain, or increased appetite. Additionally, there was no evidence of rebound insomnia after DXP discontinuation. CONCLUSIONS Five weeks of nightly administration of DXP 3 mg and 6 mg to adults with chronic primary insomnia resulted in significant and sustained improvements in sleep maintenance and early morning awakenings (with the exception of SE in the final quarter of the night on N29 for 3 mg [P=0.0691]). These sleep improvements were not accompanied by next-day residual effects or followed by rebound insomnia or withdrawal effects upon discontinuation. These findings confirm the unique profile of sleep maintenance efficacy and safety of DXP observed in prior studies.

Changes in Depressive Symptoms after Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea

It is generally believed that obstructive sleep apnea (OSA) causes depression in some patients, yet it is unknown whether this depression is an actual clinical phenomenon or purely a result of overlapping somatic/physical symptoms shared by both disorders. The present study investigated changes in both somatic and affective/cognitive symptoms of depression associated with the introduction of continuous positive airway pressure (CPAP) treatment for OSA. Participants were 39 outpatients (35 males, 4 females) with no current or past mental health problems, diagnosed with OSA in a hospital sleep disorders clinic. The Beck Depression Inventory (BDI) was administered prior to treatment and again 3 months after CPAP. Total BDI scores improved after CPAP, independent of objectively monitored CPAP compliance rates. Both somatic and affective/ cognitive symptoms of depression improved in a similar manner after treatment. Our findings suggest that depressive symptoms experienced by OSA patients are not solely the result of physical OSA symptoms but include a mood component as well. We introduce a hypothetical model to conceptualize the relationship between OSA and depression.

The Relation Between Smoking and Sleep: The Influence of Smoking Level, Health, and Psychological Variables

The relation between smoking and sleep was examined in a randomly selected sample of 769 individuals (379 men and 390 women, ages 20 to 98). Participants completed 2 weeks of sleep diaries, provided a global report on their sleep, indicated the number of cigarettes smoked per day, and supplied information on health, depressive symptoms, anxiety, and caffeine and alcohol use. After controlling for demographic, health, psychological, and behavioral variables, light smoking (< 15 cigarettes per day), but not heavier smoking, was associated with self-reported chronic insomnia and reduced sleep diary total sleep time and time in bed. Smokers did not differ significantly from nonsmokers on diary measures of sleep-onset latency, number of awakenings during the night, wake time after sleep onset, or sleep efficiency.

Efficacy and safety of doxepin 6 mg in a four-week outpatient trial of elderly adults with chronic primary insomnia

INTRODUCTION The efficacy and safety of doxepin (DXP), a histamine H(1) receptor antagonist, was evaluated in elderly adults with sleep maintenance insomnia. METHODS This was a randomized, double-blind, placebo-controlled outpatient trial. Elderly adults meeting DSM-IV-TR criteria for primary insomnia were randomized to four weeks of nightly treatment with either DXP 6 mg (N=130) or placebo (PBO; N=124). Efficacy was assessed using patient self-report instruments and clinician ratings. Patient-reported endpoints included subjective total sleep time (sTST), subjective wake after sleep onset (sWASO), latency to sleep onset (LSO), sleep quality, and a Patient Global Impression scale (PGI). The primary endpoint was sTST at week 1. RESULTS DXP 6 mg produced significantly more sTST and less sWASO at week 1 (both p-values <0.0001) than PBO. These significant improvements versus placebo were maintained at weeks 2-4 (all p-values <0.05). There were no significant differences in LSO for DXP 6 mg versus PBO. DXP 6 mg significantly improved sleep quality (weeks 1, 3, and 4, p<0.05) and several outcome-related parameters, including several items on the PGI, the severity and improvement items of the Clinician Global Impression scale (CGI; weeks 1 and 2) and the Insomnia Severity Index (ISI; weeks 1-4), all versus PBO. There were no reports of anticholinergic effects (e.g., dry mouth) or memory impairment. The safety profile of DXP 6 mg was comparable to that of PBO. CONCLUSIONS In elderly adults with insomnia, DXP 6 mg produced significant improvements in sleep maintenance, sleep duration, and sleep quality endpoints that were sustained throughout the trial. These data suggest that DXP 6 mg is effective for treating sleep maintenance insomnia and is well-tolerated in elderly adults with chronic primary insomnia.