Cognitive behavioral therapy for insomnia enhances depression outcome in patients with comorbid major depressive disorder and insomnia

STUDY OBJECTIVE: Insomnia impacts the course of major depressive disorder (MDD), hinders response to treatment, and increases risk for depressive relapse. This study is an initial evaluation of adding cognitive behavioral therapy for insomnia (CBTI) to the antidepressant medication escitalopram (EsCIT) in individuals with both disorders. DESIGN AND SETTING: A randomized, controlled, pilot study in a single academic medical center. PARTICIPANTS: 30 individuals (61% female, mean age 35 +/- 18) with MDD and insomnia. INTERVENTIONS: EsCIT and 7 individual therapy sessions of CBTI or CTRL (quasi-desensitization). Measurements and results: Depression was assessed with the HRSD17 and the depression portion of the SCID, administered by raters masked to treatment assignment, at baseline and after 2, 4, 6, 8, and 12 weeks of treatment. The primary outcome was remission of MDD at study exit, which required both an HRSD17 score < or =7 and absence of the 2 core symptoms of MDD. Sleep was assessed with the insomnia severity index (ISI), daily sleep diaries, and actigraphy. EsCIT + CBTI resulted in a higher rate of remission of depression (61.5%) than EsCIT + CTRL (33.3%). EsCIT + CBTI was also associated with a greater remission from insomnia (50.0%) than EsCIT + CTRL (7.7%) and larger improvement in all diary and actigraphy measures of sleep, except for total sleep time. CONCLUSIONS: This pilot study provides evidence that augmenting an antidepressant medication with a brief, symptom focused, cognitive-behavioral therapy for insomnia is promising for individuals with MDD and comorbid insomnia in terms of alleviating both depression and insomnia.     

Efficacy and safety of as-needed, post bedtime dosing with indiplon in insomnia patients with chronic difficulty maintaining sleep

OBJECTIVE: To evaluate the efficacy and tolerability of immediate release indiplon capsules in patients with chronic insomnia using an "as-needed" dosing strategy in response to difficulty falling back to sleep following a middle of the night, nocturnal awakening. METHODS: Adult outpatients (N=264; 71% female; age, 46 years) who met DSM-IV criteria for primary insomnia, with average total sleep time (TST) < 6.5 hours and >8 nights in the past month with nocturnal awakenings, were randomized to 4 weeks of double-blind treatment with 10 mg or 20 mg indiplon capsules, or placebo. The primary endpoint was latency to sleep onset post-dosing after a middle of the night awakening (LSOpd). Secondary endpoints included patients' subjective assessment of total sleep time (sTSTpd). Next day residual effects were evaluated by a 100 mm Visual Analog Scale (VAS) rating of sleepiness. RESULTS: Both doses of indiplon significantly reduced LSOpd at all time-points. Compared to placebo (45.2 min), the 4-week least squares (LS) mean LSOpd was 36.5 min in the indiplon 10 mg group (P = 0.0023) and 34.4 min in the indiplon 20mg group (P < 0.0001). The 4-week LS mean sTSTpd was higher in the indiplon 10 mg group (253 min) and 20mg group (278 min) compared to placebo (229 min; P < 0.01 for both comparisons). There was no increase observed in VAS ratings of next-day sleepiness for either dose of indiplon when compared to placebo. Indiplon was well-tolerated at both doses. CONCLUSIONS: Patients with chronic insomnia with nocturnal awakenings achieved significant and sustained improvement in sleep parameters while utilizing an as-needed post bedtime dosing strategy with indiplon capsules. Indiplon was well-tolerated, with no self-rated, next-day residual effects.     

Predictors of perceived sleep quality among men and women with insomnia

The present study determined which self-reported sleep variables and daytime impairment measures are most closely associated with sleep quality ratings (SQR) in men and women with insomnia. The participants were 137 people with insomnia, 56 men and 81 women. Multiple regression found that for men, sleep efficiency best predicted SQR, explaining 26.9% of variance. A similar analysis was conducted for women. After race was entered as a covariate, number of awakenings and total sleep time were significant predictors of SQR. Collectively, race, number of awakenings, and total sleep time explained 35.7% of variance. This suggests that the middle-of-the-night experience predicts sleep quality rating in women with insomnia, whereas the full night experience predicts sleep quality ratings in men with insomnia.     

Dreaming in patients with sleep disorders

Dreaming is defined as a subjective experience, while sleeping is obviously closely related to sleep physiology. The present multicenter study (n?=?4,001 patients) was designed to test whether differences in sleep physiology and daytime functioning, present in patients with sleep disorders, affect the dreaming process. Overall, patients with sleep disorders reported higher dream recall, more nightmares, and more negatively toned dreams. Whereas the differences in dream recall are most likely associated with altered sleep physiology (more frequent nocturnal awakenings and/or micro-arousals), the findings regarding nightmare frequency and dream emotions might reflect the distress associated with the sleep disorder. Desirable would be longitudinal studies; it would be expected that successful treatment should alter nightmare frequency and dream emotions in patients with insomnia, restless legs syndrome/periodic limb movement disorders, and other sleep disorders. Whether dream content reflects disorder-specific content in addition to general distress remains unanswered.     

Culturally Adapted CBTI for Chinese Insomnia Patients: a One-Arm Pilot Trial

Purpose

Insomnia is a common mental disorder with severe consequences. Cognitive-behavioral therapy for insomnia (CBTI) has been proved effective against insomnia, but most of the research is limited to Western countries. This trial objective is to develop a Chinese culture-adapted CBTI program and assess its efficacy.

Method

An 8-week culturally adapted CBTI program was developed that included mixed group and individual session and culturally adapted relaxation and cognitive restructuring treatment components. A one-arm clinical trial was conducted at a public hospital between March 2016 and January 2017. Seventy-two Chinese adults (15 males, 57 females; mean age, 50 years) with insomnia disorder underwent the culturally adapted CBTI program. Sleep diaries and self-report scales, as well as polysomnography (PSG, for a subgroup only), were used to assess qualitative and quantitative measures of sleep, mental health status, and quality of life at baseline, post-treatment, and 4-month follow-up.

Results

Pre-post analyses showed significant changes in sleep diary sleep onset latency (SOL), wake after sleep onset (WASO), and total sleep time of respectively ??37.03 min (CI, ??48.90 to ??25.16), ??28.16 min (CI, ??40.22 to ??16.10), and +?27.49 min (CI, 10.51 to 44.47). Self-reported sleep quality, mental health, and quality of life improved compared to baseline. The self-reported outcomes were mainly stable at follow-up. PSG outcomes globally failed to show improvement.

Conclusion

The design of a CBTI program adapted to Chinese population was achieved. Culturally adapted CBTI showed promising results. More rigorously designed studies are needed to ensure efficacy.

     

Cognitive, psychomotor and polysomnographic effects of trazodone in primary insomniacs

Trazodone is prescribed widely as a sleep aid, although it is indicated for depression, not insomnia. Its daytime cognitive and psychomotor effects have not been investigated systematically in insomniacs. The primary goal of this study was to quantify, in primary insomniacs, the hypnotic efficacy of trazodone and subsequent daytime impairments. Sixteen primary insomniacs (mean age 44 years) participated, with insomnia confirmed by overnight polysomnography (sleep efficiency ≤ 85%). Trazodone 50 mg was administered to participants 30 min before bedtime for 7 days in a 3-week, within-subjects, randomized, double-blind, placebo-controlled design. Subjective effects, equilibrium (anterior/posterior body sway), short-term memory, verbal learning, simulated driving and muscle endurance were assessed the morning after days 1 and 7 of drug administration. Sleep was evaluated with overnight polysomnography and modified Multiple Sleep Latency Tests (MSLT) on days 1 and 7. Trazodone produced small but significant impairments of short-term memory, verbal learning, equilibrium and arm muscle endurance across time-points. Relative to placebo across test days, trazodone was associated with fewer night-time awakenings, minutes of Stage 1 sleep and self-reports of difficulty sleeping. On day 7 only, slow wave sleep was greater and objective measures of daytime sleepiness lower with trazodone than with placebo. Although trazodone is efficacious for sleep maintenance difficulties, its associated cognitive and motor impairments may provide a modest caveat to health-care providers.     

Clinical Management of Insomnia with Brief Behavioral Treatment (BBTI)

Insomnia is a highly prevalent and debilitating sleep disorder. It is well documented that psychological treatments, including cognitive-behavioral therapy for insomnia (CBTI), are efficacious treatments, with effect sizes of comparable magnitude to that of pharmacologic treatment. However, a critical shortage of specialty-trained clinicians with experience in sleep medicine and cognitive-behavioral therapy principles has limited the widespread dissemination of CBTI. A brief (four sessions; two of which may be phone sessions) treatment, titled "Brief Behavioral Treatment for Insomnia" (BBTI), was developed to address many of the barriers to widespread dissemination associated with standard CBTI. Specifically, BBTI has an explicit behavioral focus, is overtly linked to a physiological model of sleep regulation, and utilizes a hardcopy workbook that facilitates its concise delivery format and ease of training clinicians. BBTI has demonstrated efficacy in treating older adults with insomnia ( Buysse et al., 2011 ). This article describes the rationale for the development of BBTI, provides a session-by-session guide to the delivery of the treatment, and concludes with a discussion of contraindications, combined pharmacotherapy treatment, and future directions for the use of BBTI in diverse populations and utilizing different modalities of delivery.     

Periodic movements in sleep and sleep-wake complaint

Periodic movements during sleep (PMS) are frequent, involuntary movements, usually of the lower extremities, that disrupt sleep. Twelve patients (nine men and three women, mean age 53.9 years) with a complaint of persistent insomnia (DIMS) were compared with 11 patients (eight men and three women, mean age 53.0 years) complaining of excessive daytime sleepiness (DOES). DIMS patients had more PMS (both absolute and relative), a longer delay to sleep onset and to REM onset, more wakefulness after sleep onset, and less total sleep time. Although the fragmentation of physiological sleep was more severe in the DIMS patients, those individuals with DOES reported cognitive intrusions during their sleep. While DOES patients may be regarded as "sleeping through" the brief arousals associated with leg activity during sleep, there appears to be sufficient cognitive awareness of the nocturnal interruption to precipitate a complaint of daytime sleepiness. Insomnia patients, however, appear to experience longer and more frequent awakenings, which are proportional to increased fragmentation of sleep.     

Disentangling the effects of insomnia and night work on cardiovascular diseases: a study in nursing professionals

Cardiovascular diseases (CVDs) are known to be associated with poor sleep quality in general populations, but they have not been consistently associated with specific work schedules. Studies of CVD generally do not simultaneously consider sleep and work schedules, but that approach could help to disentangle their effects. We investigated the association between insomnia and a self-reported physician diagnosis of CVD in day and night workers, considering all sleep episodes during nocturnal and diurnal sleep. A cross-sectional study was conducted in 1307 female nursing professionals from 3 public hospitals, using baseline data from the “Health and Work in Nursing - a Cohort Study.” Participants were divided into two groups: i) day workers with no previous experience in night shifts (n=281) and whose data on insomnia were related to nocturnal sleep and ii) those who worked exclusively at night (n=340) and had data on both nocturnal and diurnal sleep episodes, as they often sleep at daytime. Multiple logistic regression analysis was performed. Among day workers, insomnia complaints increased the odds of CVD 2.79-fold (95% CI=1.01-6.71) compared with workers who had no complaints. Among night workers, reports of insomnia during both nocturnal and diurnal sleep increased the odds of reported CVD 3.07-fold (95% CI=1.30-7.24). Workers with insomnia had similar probabilities of reporting CVD regardless of their work schedule, suggesting a relationship to insomnia and not to night work per se. The results also highlighted the importance of including evaluation of all sleep episodes (diurnal plus nocturnal sleep) for night workers.     

Development of sleep patterns in early adolescence

This study examines the developmental changes of sleep patterns as a function of gender and puberty and assesses the prevalence of sleep habits and sleep disturbances in early adolescence. It also investigates the relationship between sleep patterns, sleep habits and difficulty falling asleep and nocturnal awakenings. The present analyses are based on results available for 588 boys and 558 girls for whom mothers completed questions concerning demographics and sleep at annual intervals when their child was aged 10--13 years. The results indicated that nocturnal sleep times decreased, bedtimes were delayed and differences between weekend and school day sleep schedules progressively increased with age. Gender and puberty were both associated with the timing of sleep on weekends. Girls presented longer weekend time in bed (TIB) and later weekend wake time than boys. Similarly, subjects with higher pubertal status showed longer weekend TIB and later weekend wake time than subjects with lower pubertal status. Difficulty falling asleep was associated with later weekend wake time and with sleeping with a night light. In conclusion, the gender differences commonly reported in adolescents' sleep patterns are most likely explained by girls' higher pubertal status. This study emphasizes the link between puberty and a putative physiological need for more sleep, in presence of a general reduction of sleep times during adolescence. From age 10--13 years, the delay and lengthening of the sleep period on weekends in comparison to schooldays is associated with difficulty falling asleep.     

Nocturnal cardiac autonomic profile in young primary insomniacs and good sleepers

We investigated cardiac vagal and sympathetic activity in 13 young primary insomniacs (PI; 24.4 ± 1.6 years) and 14 good sleepers (GS; 23.3 ± 2.5 years) during nocturnal sleep. Pre-ejection period (PEP; inversely related to beta-adrenergic sympathetic activity), interval between consecutive R-waves (RR), and vagal-related indices of time- and frequency-domain heart rate variability were computed during pre-sleep wakefulness and undisturbed arousal-free sleep stages (N2, SWS, REM) as well as across the whole night irrespective of the presence of disruptive sleep events (e.g. sleep arousals/awakenings) and/or sleep stage transitions. Groups exhibited a similar vagal activity throughout each undisturbed sleep stage as well as considering the whole night, with a higher modulation during sleep compared to prior wakefulness. However, PEP was constantly shorter (higher sympathetic activity) during pre-sleep wakefulness and each sleep stage in PI compared to GS. Moreover, pre-sleep RR intervals were positively associated with sleep efficiency and negatively associated with wake after sleep onset in PI. Altogether our findings indicated a dysfunctional sympathetic activity but a normal parasympathetic modulation before and during sleep in young adults with insomnia.     

Ramelteon (TAK-375), a selective MT1/MT2-receptor agonist, reduces latency to persistent sleep in a model of transient insomnia related to a novel sleep environment

OBJECTIVE: Evaluate the efficacy of ramelteon, an MT/1MT2-receptor agonist, for the treatment of transient insomnia in healthy adults. DESIGN: Randomized, double-blind, placebo-controlled design using a model of transient insomnia related to sleeping in a novel environment. SETTING: Fourteen sleep research centers. PARTICIPANTS: Healthy adults (N=375; 228 women), aged 35 to 60 years, who had never previously slept in a sleep laboratory and had a reported usual sleep duration of 6.5 to 8.5 hours and usual bedtime between 8:30 PM and midnight. INTERVENTIONS: Single administration of ramelteon (16 or 64 mg) or placebo 30 minutes before bedtime. OUTCOME MEASURES: Primary efficacy measure was latency to persistent sleep. Also evaluated were total sleep time, wake after sleep onset, percentage of each sleep stage, subjective estimates of sleep from postsleep questionnaire, number of awakenings, and subjective number of awakenings. Residual effects were assessed via Digit Symbol Substitution Test and postsleep questionnaire. RESULTS: Participants in ramelteon-treated groups had significantly shorter latency to persistent sleep relative to placebo. They also were associated with significantly longer total sleep time. Wake after sleep onset and time spent in each sleep stage were not significantly different from placebo. The use of ramelteon (16 mg) was associated with a shorter subjective sleep latency compared to placebo. Other subjective measures of sleep did not differ significantly from placebo. Digit Symbol Substitution Test scores did not differ significantly among the 3 groups, but the use of the 64-mg [corrected] dose was associated with subjective reports of impairment in the morning. CONCLUSIONS: Ramelteon significantly improved latency to persistent sleep and total sleep time in this model of transient insomnia in healthy adults. No dose-related differences in latency to persistent sleep were observed, and both doses were well tolerated.     

Dysmenorrhea,the Menstrual Cycle,and Sleep

This study examined the relationship between dysmenorrhea and insomnia, as well as variability in sleep across the menstrual cycle. Participants were 89 women, ages 18 to 24 (M = 18.63, SD = 0.93), who completed daily surveys for five weeks. On the second day of menses, they completed a questionnaire regarding dysmenorrhea. Participants having insomnia rated their dysmenorrhea as being more severe and causing more interference with daily activities than did participants without insomnia. Insomnia severity was directly associated with dysmenorrhea severity and interference. Sleep onset latency was longer and sleep efficiency was lower in participants with severe dysmenorrhea than in those with mild dysmenorrhea. Further, participants with mild dysmenorrhea reported significantly better sleep quality than did those having moderate or severe dysmenorrhea. Additionally, wake time after sleep onset was shortest and number of awakenings was lowest around the time of ovulation. Future research should examine whether treating dysmenorrhea or insomnia alone results in improvements in the other condition.     

Sustained efficacy of eszopiclone over 6 months of nightly treatment: results of a randomized, double-blind, placebo-controlled study in adults with chronic insomnia

STUDY OBJECTIVES: To determine the long-term efficacy of eszopiclone in patients with chronic insomnia. DESIGN: Randomized, double-blind, multicenter, placebo-controlled. SETTING: Out-patient, with monthly visits. PATIENTS: Aged 21 to 69 years meeting DSM IV criteria for primary insomnia and reporting less than 6.5 hours of sleep per night, and/or a sleep latency of more than 30 minutes each night for at least 1 month before screening. INTERVENTIONS: Eszopiclone 3 mg (n = 593) or placebo (n = 195), nightly for 6 months MEASUREMENTS AND RESULTS: Efficacy was evaluated weekly using an interactive voice-response system. Endpoints included sleep latency; total sleep time; number of awakenings; wake time after sleep onset; quality of sleep; and next-day ratings of ability to function, daytime alertness, and sense of physical well-being. At the first week and each month for the study duration, eszopiclone produced significant and sustained improvements in sleep latency, wake time after sleep onset, number of awakenings, number of nights awakened per week, total sleep time, and quality of sleep compared with placebo (P < or = 0.003). Monthly ratings of next-day function, alertness, and sense of physical well-being were also significantly better with the use of eszopiclone than with placebo (P < or = 0.002). There was no evidence of tolerance, and the most common adverse events were unpleasant taste and headache. CONCLUSIONS: Throughout 6 months, eszopiclone improved all of the components of insomnia as defined by DSM-IV, including patient ratings of daytime function. This placebo-controlled study of eszopiclone provides compelling evidence that long-term pharmacologic treatment of insomnia is efficacious.     

Insomnia symptoms and mortality: a register‐linked study among women and men from Finland,Norway and Lithuania

Evidence on the association between insomnia symptoms and mortality is limited and inconsistent. This study examined the association between insomnia symptoms and mortality in cohorts from three countries to show common and unique patterns. The Finnish cohort comprised 6605 employees of the City of Helsinki, aged 40–60 years at baseline in 2000–2002. The Norwegian cohort included 6236 participants from Western Norway, aged 40–45 years at baseline in 1997–1999. The Lithuanian cohort comprised 1602 participants from the City of Palanga, aged 35–74 years at baseline in 2003. Mortality data were derived from the Statistics Finland and Norwegian Cause of Death Registry until the end of 2012, and from the Lithuanian Regional Mortality Register until the end of 2013. Insomnia symptoms comprised difficulties initiating sleep, nocturnal awakenings, and waking up too early. Covariates were age, marital status, education, smoking, alcohol, physical inactivity, obesity, diabetes, cardiovascular diseases, depression, shift work, sleep duration, and self‐rated health. Cox regression analysis was used. Frequent difficulties initiating sleep were associated with all‐cause mortality among men after full adjustments in the Finnish (hazard ratio 2.51; 95% confidence interval 1.07–5.88) and Norwegian (hazard ratio 3.42; 95% confidence interval 1.03–11.35) cohorts. Among women and in Lithuania, insomnia symptoms were not statistically significantly associated with all‐cause mortality after adjustments. In conclusion, difficulties initiating sleep were associated with mortality among Norwegian and Finnish men. Variation and heterogeneity in the association between insomnia symptoms and mortality highlights that further research needs to distinguish between men and women, specific symptoms and national contexts, and focus on more chronic insomnia.     

What are postpartum women doing while the rest of the world is asleep?

Large individual differences characterize maternal postpartum sleep and adjustment. Our goal was to explore aspects of mothers’ nocturnal environments and behaviours that may explain differences in postpartum adjustment. A total of 201 mothers of infants aged 0–6 months completed an online survey with demographics, number and duration of nocturnal awakenings, caretaking behaviours, environment and nocturnal activities during ‘one typical night during the past week’. Mothers reported 2.9 [standard deviation (SD) ± 1.7] nocturnal awakenings, each lasting 33.9 (SD ± 22.5) min. Infant age was related inversely to duration but unrelated to number of awakenings. Falling asleep while feeding was less frequent among exclusively formula‐feeders. Among the entire sample, mothers used a cellphone (59%), backlit tablet (25%), TV (20%) and computer (16%) during nocturnal awakenings. Watching TV and using a computer were each associated with longer nocturnal awakenings. Eighty‐nine per cent of women used ≥1 extra light source during nocturnal awakenings: night light (35%), light from a cracked door (28%), desk lamp (25%), electronic device (19%) or room light (14%). Light source(s) was unrelated to number or duration of nocturnal awakenings. These data suggest that, although supplemental light sources were not associated with awakenings, TV and computer use accounted for longer awakenings. Feeding method and technology use may help to explain individual differences in postpartum adjustments and may be targets for more effective interventions.     

ELECTROMYOGRAM SUPPRESSION DURING SLEEP, DREAM RECALL, AND ORIENTATION TIME

Five subjects had their nocturnal sleep monitored (EEG, EOG, submental EMG) for a total of 42 nights. A total of 196 awakenings to retrieve sleep mentation was distributed among three awakening categories: Non-Rapid Eye Movement (NREM) sleep before the EMG suppression heralding REM-sleep onset; NREM sleep immediately following the EMG suppression heralding REM-sleep onset; and early moments of REM sleep accompanied by EMG suppression. Suppressed-EMG NREM awakenings tended to be associated with lower dream recall frequency and lower Dreamlike Fantasy Scale ratings than did high-EMG NREM awakenings. Orientation times upon experimental awakenings were longer on suppressed-EMG pre-REM awakenings than on high-EMG pre-REM awakenings. A momentary “deepening” of sleep (in terms of less memorable and vivid mental content and of decreased reactivity to the awakening stimulus) thus appears to accompany the pre-REM suppression of neck and chin EMG potentials.     

Electrodermal activity in patients with persistent insomnia

SUMMARY  In order to evaluate daytime arousal in patients with persistent insomnia, electrodermal activity (EDA) was measured in a habituation paradigm (21 tones, 80 dB, 1s) in forty patients with persistent insomnia and in twenty normal subjects. Results showed that the patients had higher EDA than the controls implying a higher arousal level in the patients. Among the patients the distribution of trials to a habituation criterion was bimodal and patients were separated into habituators ( n = 24) and non-habituators ( n = 16). Non-habituators had significantly higher EDA than habituators and they also had a shorter nocturnal sleep time. Thus, daytime arousal was significantly related to nocturnal sleep in the patients. Both patients with Psychophysiological Insomnia and Insomnia Associated with Psychiatric Disorders had higher EDA than the controls, and EDA was also significantly related to sleep in both groups. Results lend further support for the notion of an excessive daytime arousal, which may serve as a common predisposing factor in the initiation or maintenance of persistent insomnia.     

Insomnia and global sleep dissatisfaction in Finland

The purpose of this study is to assess the prevalence of insomnia symptoms and diagnoses in the general population of Finland. A total of 982 participants, aged 18 years or older and representative of the general population of Finland, were interviewed by telephone using the Sleep-EVAL system. The participation rate was 78%. The questionnaire included the assessment of sleep habits, insomnia symptomatology according to Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) and International Classification of Sleep Disorders (ICSD), associated and sleep/mental disorders and daytime consequences. The overall prevalence of insomnia symptoms occurring at least three nights per week was 37.6%. Difficulty initiating sleep were mentioned by 11.9% of the sample, difficulty maintaining sleep by 31.6%, early morning awakenings by 11.0% and non-restorative sleep by 7.9% of the sample. Global dissatisfaction with sleep was found in 11.9% of the sample. Daytime consequences (fatigue, mood changes, cognitive difficulties or daytime sleepiness) were reported by 39.9% of participants with insomnia symptoms and 87.6% of those with sleep dissatisfaction. A deterioration of sleep in summer or winter was associated with more complaints of sleep dissatisfaction. Prevalence of any DSM-IV insomnia diagnosis was 11.7%. More specifically, DSM-IV diagnosis of primary insomnia had a prevalence of 1.6% and DSM-IV diagnosis of insomnia related to another mental disorder was at 2.1%. Insomnia was a symptom of another sleep disorder in about 16% of cases and of a mental disorder in about 17% of cases. As reported in other Nordic studies, sleep quality was worse in summer. Insomnia symptomatology was common and was reported by more than a third of Finnish participants. Compared with other European countries studied with the same methodology (France, the UK, Germany, and Italy), the prevalence of DSM-IV insomnia diagnosis was 1.5 to two times higher in Finland.     

Long-term nightly treatment with indiplon in adults with primary insomnia: results of a double-blind, placebo-controlled, 3-month study

OBJECTIVES: To evaluate the efficacy and safety of indiplon in primary insomnia. DESIGN: Randomized, double-blind, placebo-controlled, 3-month study. SETTING: Multi-center outpatient setting. PATIENTS: N=702 (61% female; mean age 46 years) who met DSM-IV criteria for primary insomnia of at least 3 months' duration. Interventions: Indiplon 10 mg (n=236), indiplon 20 mg (n=233), or placebo (n=233). MEASUREMENTS: Subjective assessment of each of the following: latency to sleep onset (sLSO), total sleep time (sTST), number of awakenings after sleep onset (sNAASO), wake time after sleep onset (sWASO), sleep quality, Insomnia Severity Index (ISI), and global improvement. RESULTS: Treatment with indiplon resulted in significant improvement relative to placebo at all time points for the primary endpoint, sLSO. Mean sLSO at Month 1 for each treatment group was: 10 mg (34.0 +/- 1.3 mins), 20 mg (33.0 +/- 1.3 mins), and placebo (48.7 +/- 1.9 mins; P <0.0001 for both comparisons); efficacy was sustained through Month 3. Both doses of indiplon resulted in significant improvement in sleep maintenance and duration endpoints, sTST and sWASO, as well as sleep quality, ISI, and global improvement at all assessment time points. CONCLUSIONS: In patients with chronic insomnia, long-term nightly treatment with 10 mg and 20 mg doses of indiplon resulted in significant and sustained efficacy in sleep onset, maintenance, and duration, and significant associated improvement in both daytime functioning and quality of life.