The effects of pregabalin on sleep disturbance symptoms among individuals with fibromyalgia syndrome

ObjectivesSleep disturbances are common in patients with fibromyalgia (FM). The objective of this analysis was to evaluate the effects of pregabalin on sleep in patients with FM.MethodsAnalyses were based on two randomized, double-blind, placebo-controlled trials of pregabalin (300 mg, 450 mg, and 600 mg daily) in adult FM patients. Sleep outcomes included the Medical Outcomes Study (MOS) Sleep Scale and a daily diary assessment of sleep quality. Treatment effects were evaluated using analysis of covariance. Clinically important differences (CID) in the Sleep Quality Diary and MOS Sleep Disturbance scores were estimated using mixed-effects models of changes in scores as a function of patients’ global impressions of change. Mediation modeling was used to quantify the direct treatment effects on sleep in contrast to indirect influence of the treatment on sleep via pain.ResultsA total of 748 and 745 patients were randomized in the respective studies. Patients were predominantly Caucasian females, average age 48–50 years, on average had FM for 9–10 years, and experienced moderate to severe baseline pain. Pregabalin significantly improved the Sleep Quality Diary (P < 0.001), MOS Sleep Disturbance (P < 0.01), MOS Quantity of Sleep (P < 0.003), and MOS Sleep Problems Index scores (P < 0.02) relative to placebo. Treatment effects for the 450 mg and 600 mg groups exceeded the estimated CID thresholds of 0.83 and 7.9 for the Sleep Quality Diary and MOS Sleep Disturbance scores, respectively. Mediation models indicated that 43–80% of the benefits on sleep (versus placebo) were direct effects of pregabalin, with the remainder resulting from an indirect effect of treatment via pain relief.ConclusionsThese data demonstrate improvement in FM-related sleep dysfunction with pregabalin therapy. The majority of this benefit was a direct effect of pregabalin on the patients’ insomnia, while the remainder occurred through the drug’s analgesic activity.     

A randomized placebo-controlled polysomnographic study of eszopiclone in Japanese patients with primary insomnia

ObjectivesTo evaluate the efficacy and dose–response effect of eszopiclone on sleep latency and sleep maintenance in Japanese patients with primary insomnia.MethodsIn this randomized, double-blind, five-way crossover study, 72 patients received placebo, eszopiclone 1 mg, 2 mg, and 3 mg, and zolpidem 10 mg in random order for two consecutive nights with a washout period between treatments. Objective sleep measures from polysomnography (PSG) and subjective patient reports were collected.ResultsAll active treatments produced significant improvement in objective and subjective sleep latency compared with placebo (P < 0.05 for all comparisons); linear dose–response relationships were observed for eszopiclone. PSG-determined wake time after sleep onset (WASO), sleep efficiency, and number of awakenings (NA), and patient-reported measures of WASO, NA, sleep quality, sleep depth, and daytime functioning significantly improved following treatment with eszopiclone 2 mg and 3 mg and zolpidem 10 mg versus placebo (P < 0.05). Eszopiclone at all doses increased total sleep time and stage 2 sleep time (P < 0.001 for both comparisons), but did not alter REM or slow-wave sleep. Eszopiclone was generally well tolerated; the most frequently reported adverse event was mild dysgeusia.ConclusionsIn Japanese patients with primary insomnia, eszopiclone 2 mg and 3 mg significantly improved PSG-determined and patient-reported sleep latency and sleep maintenance relative to placebo.     

A 2-week efficacy and safety study of gaboxadol and zolpidem using electronic diaries in primary insomnia outpatients

ObjectivesTo evaluate the efficacy and safety profile of gaboxadol, a selective extrasynaptic GABA_A agonist (SEGA) previously in development for the treatment of insomnia.MethodsThis was a randomised, double-blind, placebo-controlled, parallel-group, 2-week, Phase III study of gaboxadol 5, 10 and 15 mg in outpatients meeting the DSM-IV criteria of primary insomnia (N = 742). Zolpidem 10 mg was used as active reference.ResultsAt weeks 1 and 2, significant improvement in total sleep time (sTST) compared to placebo was seen for all doses of gaboxadol (all p < 0.05). In addition, gaboxadol 10 and 15 mg decreased the number of awakenings (sNAW) (p < 0.05) while only gaboxadol 15 mg improved wakefulness after sleep onset (sWASO) (p < 0.05). At week 1, all doses of gaboxadol significantly improved time-to-sleep onset (sTSO) (p < 0.05). At week 2, a sustained effect on sTSO was observed for gaboxadol 15 mg. Zolpidem also showed effect on all of these variables. Gaboxadol and zolpidem improved sleep quality, freshness after sleep, daytime function and energy at both weeks. Transient rebound insomnia was observed following discontinuation of treatment with zolpidem, but not gaboxadol.ConclusionsGaboxadol 15 mg treatment for 2 weeks significantly improved sleep onset and maintenance variables as well as sleep quality and daytime function, as did zolpidem. Gaboxadol 5 and 10 mg also showed benefits on most efficacy variables. Gaboxadol was generally safe and well tolerated, with no evidence of withdrawal symptoms or rebound insomnia after discontinuation of short-term treatment. For zolpidem, transient rebound insomnia was observed.     

A randomized,double-blind, 6-week,dose-ranging study of pregabalin in patients with restless legs syndrome

ObjectiveThis study evaluated the dose-related efficacy and safety of pregabalin in patients with idiopathic restless legs syndrome (RLS).MethodsThis six-arm, double-blind, placebo-controlled, dose–response study randomized patients (N = 137) with moderate-to-severe idiopathic RLS in an equal ratio to placebo or pregabalin 50, 100, 150, 300, or 450 mg/day. The dose–response was characterized using an exponential decay model, which estimates the maximal effect (E_max) for the primary endpoint, the change in the International Restless Legs Study Group Rating Scale (IRLS) total score from baseline to week 6 of treatment. Secondary outcomes included Clinical Global Impressions-Improvement Scale (CGI-I) responders, sleep assessments, and safety.ResultsThe separation of treatment effect between placebo and pregabalin began to emerge starting at week 1 which continued and increased through week 6 for all dose groups. The IRLS total score for pregabalin was dose dependent and well characterized for change from baseline at week 6. The model estimated 50% (ED₅₀) and 90% (ED₉₀) of the maximal effect in reducing RLS symptoms that occurred at pregabalin doses of 37.3 and 123.9 mg/day, respectively. A higher proportion of CGI-I responders was observed at the two highest doses of pregabalin (300 and 450 mg/day) versus placebo. Dizziness and somnolence were the most common adverse events and appeared to be dose-related.ConclusionsIn this 6-week phase 2b study, pregabalin reduced RLS symptoms in patients with moderate-to-severe idiopathic RLS. The symptom reduction at week 6 was dose-dependent with 123.9 mg/day providing 90% efficacy. Pregabalin was safe and well tolerated across the entire dosing range.     

El insomnio y la pobre calidad de sueño se asocian a un mal control de crisis en pacientes con epilepsia

ObjectivesThis study aimed to assess the presence of sleep disorders in patients with epilepsy and to analyse their association with seizure control.MethodsWe performed a cross-sectional study of patients with epilepsy, recruited consecutively between September 2017 and December 2018. Patients were classified as having good seizure control (no seizures in the last 4 weeks) or poor seizure control (at least one seizure in the last 4 weeks). We performed intergroup comparisons for demographic and clinical data, insomnia (Insomnia Severity Index [ISI]), excessive daytime sleepiness (Epworth Sleepiness Scale [ESS]), sleep quality (Pittsburgh Sleep Quality Index [PSQI]), depression (Beck Depression Inventory-II [BDI-II]), and quality of life (Quality of Life in Epilepsy Inventory-10 [QOLIE-10]).ResultsThe sample included a total of 123 patients, of whom 31.7% had excessive daytime sleepiness (ESS ≥ 10), 50.4% had insomnia (ISI ≥ 10), and 53.6% had poor sleep quality (PSQI ≥ 5). According to our multivariate analysis, presence of seizures was associated with unemployment (odds ratio [OR] = 4.7; 95% confidence interval [CI], 1.36-19.2; P = .02), a higher number of antiepileptic drugs (OR = 5.87; 95% CI, 1.81-27.1; P < .001), insomnia (OR = 1.9; 95% CI, 1.1-9.3; P = .04), and poor sleep quality (OR = 2.8; 95% CI, 1.9-10.32; P = .01).ConclusionsSleep disorders are common in patients with epilepsy. Insomnia and poor sleep quality were associated with poor seizure control. These findings support the hypothesis that sleep disorders constitute a significant comorbidity of epilepsy, especially in patients with poor seizure control.     

Treatment of elderly primary insomnia patients with EVT 201 improves sleep initiation,sleep maintenance,and daytime sleepiness

ObjectiveTwo doses of EVT 201, a partial positive allosteric modulator of the GABA_A system, were evaluated in elderly primary insomnia patients with daytime sleepiness.Patients and methodsParticipants were 149 elderly patients with DSM-IV primary insomnia including evidence of daytime sleepiness (53 males, 96 females; mean age 71.3 yrs, range 65–86 yrs). A randomized, multicentre, double-blind, placebo-controlled, parallel-group design was used to assess the hypnotic efficacy of EVT 201 1.5 and 2.5 mg during seven consecutive nights. Polysomnography (PSG) was performed on nights 1, 6 and 7 of treatment. Daytime assessments on Day 8 included the multiple sleep latency test (MSLT), Rey Auditory Verbal Learning Test (RAVLT), Psychomotor Vigilance Task (PVT) and the Karolinska Sleepiness Scale (KSS). The primary endpoint was total sleep time (TST) and the key secondary endpoint was mean MSLT latency.ResultsCompared to placebo, EVT 201 1.5 and 2.5 mg increased TST (30.9, 56.4 min, respectively; p = 0.0001, p < 0.0001); reduced wake after sleep onset (WASO; ?15.2, ?36.1 min, respectively; p = 0.014, p < 0.0001); reduced latency to persistent sleep (LPS; ?15.9, ?19.9 min, respectively; p = 0.009, p = 0.001). The 2.5 mg dose also reduced WASO in hours 5–8 (?16.3 min, p = 0.001). Both doses also improved subjective sleep quality and usual subjective efficacy measures. A significantly longer mean MSLT latency was observed on Day 8 with both doses, compared to placebo (2 min increase; p = 0.03, both doses). The PVT, RAVLT, and POMS did not differ among treatment groups. No serious or unexpected treatment emergent adverse events were noted.ConclusionEVT 201 improved PSG measures of sleep onset and sleep maintenance and significantly reduced daytime physiological sleep tendency. These findings suggest that treatment of primary insomnia in older patients has the potential to improve daytime sleepiness as well as sleep.     

Efficacy and safety of doxepin 6 mg in a model of transient insomnia

IntroductionThe efficacy and safety of doxepin (DXP) 6 mg tablets were evaluated in healthy adults in a model of transient insomnia.MethodsThis was a randomized, double-blind, parallel-group, placebo-controlled study in healthy adults using a model of transient insomnia. A first-night effect combined with a 3-h phase advance was implemented to induce transient insomnia in healthy adults. Subjects received a single night time dose of placebo (PBO; N = 282) or DXP 6 mg (N = 283) in a sleep laboratory. Efficacy was evaluated objectively (polysomnography; PSG) and subjectively (morning questionnaire). Consistent with the model utilized, the primary endpoint was latency to persistent sleep (LPS); secondary PSG endpoints included wake after sleep onset (WASO; key secondary endpoint), total sleep time (TST), wake time after sleep (WTAS) and sleep efficiency (SE; overall, by quarter of the night and hourly); secondary subjective endpoints included latency to sleep onset (LSO), subjective WASO (sWASO), subjective TST (sTST) and sleep quality.ResultsDXP 6 mg demonstrated statistically significant improvements in LPS (13 min decrease versus PBO; p < 0.0001), WASO (39 min less than PBO; p < 0.0001), TST (51 min more than PBO; p < 0.0001), WTAS (p < 0.0001), overall SE (p < 0.0001), SE in each quarter of the night (p < 0.0001) and SE in each of the 8 h (p ? 0.0003), all versus PBO. Additionally, DXP 6 mg significantly improved subjective variables including LSO (p < 0.0001), sWASO (p = 0.0063), sTST (p < 0.0001), and sleep quality (p = 0.0004), versus PBO. There was no consistent evidence of next-day residual sedation and also minor sleep stages alterations. The incidence of adverse events was comparable to placebo.ConclusionsIn this model of transient insomnia, DXP 6 mg demonstrated significant improvements in sleep onset, sleep maintenance, sleep duration and sleep quality, and also appeared to reduce early morning awakenings. These data suggest that DXP 6 mg may be effective and well tolerated in adults experiencing transient insomnia.     

Sleep misperception in persons with epilepsy

Being able to confidently ascertain the amount of sleep is critical to the clinical management of epilepsy. Sleep misperception is the phenomenon in which an individual underestimates the amount of time spent asleep. Little is known about sleep misperception in patients with epilepsy.We conducted retrospective chart reviews on individuals who self-identified as having epilepsy in a questionnaire database of patients undergoing polysomnography (PSG) at the Massachusetts General Hospital Sleep Laboratory. Our metric for sleep misperception was the difference between subjective and objective sleep latency (S–O SL) and subjective and objective total sleep time (S–O TST) with subjective values based on questionnaire and objective values based on PSG.We confirmed 64 patients with epilepsy. We then selected age- and sex-matched diagnostic PSG data for comparison from 50 patients with insomnia symptoms but no obstructive sleep apnea (OSA) and another 50 patients with OSA but no insomnia symptoms. In our cohort with epilepsy, the median SL overestimation was 20 min (p < 0.05), and the median TST underestimation was 45 min (p < 0.05). Sleep misperception was similar regardless of potential confounding factors such as categorical epilepsy refractoriness, cognitive impairment, or psychiatric comorbidity.Our findings suggest that sleep misperception occurs similarly in patients with epilepsy as in patients without epilepsy with insomnia. Our findings further support the potential clinical utility of objective PSG testing in patients with epilepsy, as this may not only identify occult OSA but also disclose sleep misperception.     

Sleep maintenance insomnia complaints predict poor CPAP adherence: A clinical case series

BackgroundAlthough CPAP is a highly efficacious treatment for obstructive sleep apnea (OSA), low adherence presents a significant challenge for sleep medicine clinicians. The present study aimed to evaluate the relationship between insomnia symptoms and CPAP use. We hypothesized that pre-treatment insomnia complaints would be associated with poorer CPAP adherence at clinical follow-up.MethodsThis was a retrospective chart review of 232 patients (56.5% men, mean age = 53.6 ± 12.4 years) newly diagnosed with OSA (mean AHI = 41.8 ± 27.7) and prescribed CPAP in the Johns Hopkins Sleep Disorder Center. Difficulty initiating sleep, difficulty maintaining sleep, and early morning awakening were measured via three self-report items. CPAP use was measured via objective electronic monitoring cards.ResultsThirty-seven percent of the sample reported at least one frequent insomnia complaint, with 23.7% reporting difficulty maintaining sleep, 20.6% reporting early morning awakening and 16.6% reporting difficulty initiating sleep. After controlling for age and gender, sleep maintenance insomnia displayed a statistically significant negative relationship with average nightly minutes of CPAP use (p < .05) as well as adherence status as defined by the Centers for Medicaid and Medicare Services (p < .02).ConclusionsTo our knowledge, these are the first empirical data to document that insomnia can be a risk factor for poorer CPAP adherence. Identifying and reducing insomnia complaints among patients prescribed CPAP may be a straightforward and cost-effective way to increase CPAP adherence.     

Effect of successful epilepsy surgery on subjective and objective sleep parameters – a prospective study

ObjectiveTo evaluate the effect of surgery on subjective and objective measures of sleep quality among patients with medically refractory focal epilepsy.MethodsIn a prospective cohort study, patients with medically refractory epilepsy undergoing epilepsy surgery were recruited. All patients were assessed seven days pre- and three months post-surgery in terms of history pertaining to epilepsy and sleep, Epworth sleepiness score (ESS), one week sleep log and over night polysomnography (PSG).ResultsAmong 17 patients (mean age 18, 11 males), seizure frequency had reduced (p = 0.04) and self reported sleep parameters had significantly improved (reduced total duration of night time sleep, regularity on one week sleep log and ESS (p < 0.05)) three months following epilepsy surgery. Patients with good surgical outcome (n = 12) showed reduced seizure frequency (p = 0.01) and reduced ESS with corresponding reduction in arousal index (AI) (p = 0.02) and increase in total sleep time (p = 0.03), postoperatively. Three patients in the good surgical outcome group showed reduction in apnea–hypopnea index (AHI) from more than five to less than five. There was no significant change either in seizure frequency, self reported clinical parameters or PSG parameters among patients with poor surgical outcome.ConclusionEpilepsy surgery improves subjective sleep parameters in patients with medically refractory epilepsy during the early post operative period. Successful epilepsy surgery may improve objective (PSG documented) sleep quality, sleep architecture and obstructive sleep apnea with resultant reduction in excessive daytime sleepiness.     

Aerobic exercise improves self-reported sleep and quality of life in older adults with insomnia

ObjectiveTo assess the efficacy of moderate aerobic physical activity with sleep hygiene education to improve sleep, mood and quality of life in older adults with chronic insomnia.MethodsSeventeen sedentary adults aged ?55 years with insomnia (mean age 61.6 [SD ± 4.3] years; 16 female) participated in a randomized controlled trial comparing 16 weeks of aerobic physical activity plus sleep hygiene to non-physical activity plus sleep hygiene. Eligibility included primary insomnia for at least 3 months, habitual sleep duration <6.5 h and a Pittsburgh Sleep Quality Index (PSQI) score >5. Outcomes included sleep quality, mood and quality of life questionnaires (PSQI, Epworth Sleepiness Scale [ESS], Short-form 36 [SF-36], Center for Epidemiological Studies Depression Scale [CES-D]).ResultsThe physical activity group improved in sleep quality on the global PSQI (p < .0001), sleep latency (p = .049), sleep duration (p = .04), daytime dysfunction (p = .027), and sleep efficiency (p = .036) PSQI sub-scores compared to the control group. The physical activity group also had reductions in depressive symptoms (p = .044), daytime sleepiness (p = .02) and improvements in vitality (p = .017) compared to baseline scores.ConclusionAerobic physical activity with sleep hygiene education is an effective treatment approach to improve sleep quality, mood and quality of life in older adults with chronic insomnia.     

Predictors and patterns of insomnia symptoms in OSA before and after PAP therapy

ObjectiveIdentify factors that predict improvement versus persistence of insomnia symptoms following treatment of obstructive sleep apnea (OSA) with positive airway pressure (PAP) therapy.MethodsArchival data from 68 PAP-treated sleep apnea patients aged 25–83 were analyzed using nonparametric tests and stepwise regression to assess the relationships between insomnia symptoms, multiple OSA variables, and PAP use over time.ResultsPretreatment insomnia symptom severity (ISS; b = −0.72, p < 0.001), PAP average use (b = −0.01, p = 0.01) and respiratory disturbance index (RDI; b = −0.02, p = 0.03) predict change in insomnia following PAP therapy. Forty-five percent (24/53) of the subjects with moderate to severe insomnia at pretreatment reported no/mild symptoms after PAP therapy and were considered improved. Improved subjects had lower pretreatment ISS (p < 0.001), higher RDI (p = 0.01), and higher average PAP use (p < 0.035) than subjects with persistent insomnia. Number of medications and comorbidities were similar between improved and persistent groups. New onset of insomnia symptoms occurred in 13% (2/15) of the patients with no/mild pretreatment insomnia.ConclusionsAlthough ISS declines following PAP treatment, 55% of OSA patients have persistent moderate to severe symptoms despite treatment. More severe OSA is linked to higher likelihood of insomnia improvement and the effect of PAP therapy on insomnia may be mediated by OSA severity. Persistent insomnia is unrelated to medication use or comorbidities and may represent an independent, self-sustaining disorder requiring targeted intervention.     

Psychometric properties and clinical relevance of the Adolescent Sleep Hygiene Scale in Dutch adolescents

ObjectiveThis study investigated reliability, validity, and clinical relevance of the Adolescent Sleep Hygiene Scale (ASHS) in Dutch adolescents.MethodsThe Dutch translation of the ASHS was administered to 186 normal-sleeping adolescents and 112 adolescents with insomnia. Their sleep variables were measured using sleep logs and questionnaires. From the insomnia group, scores were also obtained after six weeks of cognitive behavioral therapy for insomnia (n = 58) or waiting list (n = 22).ResultsThe full scale of the ASHS had acceptable internal consistency. The results showed moderate to strong correlations of the ASHS (domains) with sleep quality, sleep duration and chronic sleep reduction. Furthermore, the Dutch ASHS was able to discriminate between normal sleepers and adolescents with insomnia, and scores of adolescents with insomnia improved after treatment.ConclusionsThese findings confirm the importance of sleep hygiene in adolescent sleep, and contribute to the validity of the ASHS and its applicability in research and clinical practice.     

Attribution,cognition and psychopathology in persistent insomnia disorder: outcome and mediation analysis from a randomized placebo-controlled trial of online cognitive behavioural therapy

ObjectivesInsomnia patients complain that mental events keep them awake. This study investigates how cognitive behavioural therapy (CBT) affects such events and considers how attributional, cognitive and psychopathological symptoms may mediate sleep improvement.MethodA pragmatic, parallel-group randomized controlled trial of 164 adults (120 F: (mean 49 years (18–78 years)) meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for insomnia disorder, assigned to CBT (n = 55; 40 F), imagery relief therapy (IRT placebo; n = 55; 42 F), or treatment as usual (TAU; n = 54; 38 F), was conducted. CBT/IRT comprised six online sessions delivered by an animated therapist, with automated web/e-mail support. CBT users had access to a moderated community. TAU comprised ‘usual care’. Participants completed the Sleep Disturbance Questionnaire (SDQ), Glasgow Content of Thoughts Inventory (GCTI), Depression Anxiety and Stress Scales (DASS) and Sleep Condition Indicator (SCI) at baseline, post treatment and 8-week follow-up.ResultsThe sample was characterised by mental arousal, notably ‘trying too hard’ to sleep (SDQ), and by ‘sleep and sleeplessness’ and ‘rehearsal and planning’ thoughts (GCTI). Treatment effects were observed for all SDQ domains (e.g., CBT vs. IRT: d = 0.76 for ‘trying too hard’). CBT was also superior to IRT on the GCTI (e.g., ‘rehearsal and planning’, d = 0.62; ‘sleep and sleeplessness’, d = 0.74). CBT vs. TAU comparisons yielded larger effects, whereas placebo effects (IRT vs. TAU) were small to moderate. Hierarchical regression demonstrated partial mediation of SCI improvement by attributional and cognitive factors (R² = 21–27%) following CBT. Improvement in sleep efficiency appears to be independent of such factors.ConclusionOnline CBT modifies sleep-related attributions, night-time thought content and psychopathology. This process partly mediates improvement in DSM-5-defined insomnia.     

Severity of self-reported insomnia in adults with epilepsy is related to comorbid medical disorders and depressive symptoms

BackgroundFew studies have systematically investigated insomnia in adults with epilepsy.MethodsWe performed a prospective cross-sectional investigation of the prevalence, severity, and comorbidities of insomnia in 90 adults with epilepsy using a battery of self-reported instruments and polysomnography. We quantified insomnia severity using the Insomnia Severity Index (ISI).ResultsFifty-nine of 90 (65.5%) adults with epilepsy reported insomnia (ISI ≥ 8), moderate or severe (ISI ≥ 15) in 28.9%. Good agreement between standard clinical diagnostic criteria and ISI was found for patients with ISI scores < 8 and ≥ 15. Scores on the modified Beck Depression Inventory (mBDI) (r = 0.25, p = 0.021), the original BDI (r = 0.32, p = 0.002), and self-reported total sleep duration (TSD) (r = − 0.3, p = 0.006) were significantly related to ISI score. A multiple regression model found that decreased TSD (ß = − 0.93, p = 0.007), head trauma (ß = 4.37, p = 0.003), sedative–hypnotic use (ß = 4.86, p = 0.002), AED polytherapy (ß = 3.52, p = 0.005), and asthma/COPD (ß = 3.75, p = 0.014) were predictors of a higher ISI score. For 63 patients with focal epilepsy, an increased mBDI (ß = 0.24, p = 0.015), decreased TSD (ß = − 1.11, p = 0.008), asthma/COPD (ß = 4.19, p = 0.02), and epilepsy surgery (ß = 5.33, p = 0.006) were significant predictors of an increased ISI score. Patients with temporal lobe epilepsy (TLE) showed a trend for greater severity compared with those with extra-TLE (ß = − 2.92, p = 0.054).ConclusionsOur findings indicate that severity of insomnia in adults with epilepsy is more likely to be associated with comorbid medical and depressive symptoms and less likely to be directly related to epilepsy. Good agreement between standard clinical diagnostic criteria for insomnia and the ISI for subjects without insomnia symptoms and for those with moderate-to-severe symptoms supports the use of this instrument in epilepsy research.     

Comparing sleep profiles between patients with juvenile myoclonic epilepsy and symptomatic partial epilepsy: Sleep questionnaire-based study

ObjectivesPatients with epilepsy commonly report excessive daytime sleepiness and daytime fatigue, which may be attributed to the direct effect of seizures, a side effect of antiepileptic drugs or a combination of the two. The aim of the study was to compare sleep profiles in patients with juvenile myoclonic epilepsy (JME) and symptomatic partial epilepsy (PE) in drug naïve and treated patients using standardized sleep questionnaires.MethodsThree study groups: - 1) juvenile myoclonic epilepsy (N = 40) [drug naïve (N = 20); On sodium valproate (SVA) (N = 20)]; 2) symptomatic partial epilepsy (N = 40) [drug naïve (N = 20); On carbamazepine (CBZ) (N = 20)]; 3) healthy controls (N = 40) completed 3 standardized sleep questionnaires – Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, and NIMHANS Comprehensive Sleep Disorders Questionnaire. Scores were compared using t-test and Chi-squared tests (P ≤ 0.005).ResultsThe mean PSQI scores as well as the proportion of subjects with abnormal PSQI scores were higher in patients with JME and PE compared to controls. Although the mean ESS scores were comparable between patients with epilepsy and controls, the percentage of patients with partial epilepsy having abnormal ESS scores was higher. No significant differences were present between drug naïve and treatment monotherapy groups. Excessive daytime somnolence was reported more often by patients with JME compared to patients with partial epilepsy and controls.ConclusionThis study found that patients with epilepsy have a higher prevalence of poor sleep quality compared to controls. Moreover, a significantly higher percentage of patients with partial epilepsy had higher ESS scores compared to healthy controls. However, there was no difference between ESS and PSQI scores between drug naïve and treated patients with JME or PE.SignificancePoor sleep quality is more prevalent in patients with epilepsy irrespective of the use of antiepileptic medications. Excessive daytime somnolence is more commonly seen in patients with partial epilepsy when compared to the general population.     

Neuropsychological and behavioural aspects in children and adolescents with idiopathic epilepsy at diagnosis and after 12 months of treatment

PurposeTo study neuropsychological functions in children with idiopathic epilepsy at onset of treatment and after 1 year of therapy and to identify factors associated with cognitive impairment.Methods43 Subjects aged 5.2–16.9 years with newly diagnosed idiopathic epilepsy were enrolled and started treatment with valproate or carbamazepine. At admission and after 12 months, all patients underwent clinical examinations, the Child Behavioural Checklist, EEG and a neuropsychological test battery. The results of each test were correlated to demographic, clinical, electrophysiological and therapeutic variables.ResultsExcept for attention, all neuropsychological functions were normal at admission and after 12 months. An improvement with time was noted for memory (p < 0.05) and logical-executive functions (p < 0.01). Attentive deficit was worse at 12 months (53.5% vs. 32.6%). Low socio-economic level and emotional and behavioural disturbances were the only factors negatively correlated to intelligence, memory and attention. Compared to valproate, carbamazepine was most commonly implicated.DiscussionIdiopathic epilepsy can affect attention, even before starting treatment. Emotional and behavioural difficulties and a low socio-economical status are associated with cognitive impairment.     

Placebo-controlled comparison of prazosin and cognitive-behavioral treatments for sleep disturbances in US Military Veterans

ObjectivePharmacological and cognitive-behavioral treatments targeting insomnia and nightmares have been shown to be effective in the treatment of military veterans with sleep complaints comorbid with symptoms of stress-related disorders, including Post-Traumatic Stress Disorder (PTSD), but the two approaches have not been directly compared. This randomized controlled trial compared the effects of prazosin vs. a behavioral sleep intervention (BSI), targeting nightmares and insomnia against a placebo pill control condition on sleep and daytime symptoms.MethodsFifty United States military veterans (mean age 40.9 years, SD = 13.2 years) with chronic sleep disturbances were randomized to prazosin (n = 18), BSI (n = 17), or placebo (n = 15). Each intervention lasted 8 weeks. Participants completed self-report measures of insomnia severity, sleep quality, and sleep disturbances. All kept a sleep diary throughout the intervention period. Polysomnographic studies were conducted pre- and post-intervention.ResultsBoth active treatment groups showed greater reductions in insomnia severity and daytime PTSD symptom severity. Sleep improvements were found in 61.9% of those who completed the active treatments and 25% of those randomized to placebo.ConclusionBSI and prazosin were both associated with significant sleep improvements and reductions in daytime PTSD symptoms in this sample of military veterans. Sleep-focused treatments may enhance the benefits of first-line PTSD treatments.     

A randomized clinical trial of valerian fails to improve self-reported, polysomnographic, and actigraphic sleep in older women with insomnia

ObjectiveTo test the effects of nightly valerian (Valeriana officinalis) extract to improve sleep of older women with insomnia.MethodsParticipants in this phase 2 randomized, double-blind, crossover controlled trial were 16 older women (mean age = 69.4 ± 8.1 years) with insomnia. Participants took 300 mg of concentrated valerian extract or placebo 30 min before bedtime for 2 weeks. Sleep was assessed in the laboratory by self-report and polysomnography (PSG) at baseline and again at the beginning and end of each treatment phase (total of nine nights in the laboratory) and at home by daily sleep logs and actigraphy.ResultsThere were no statistically significant differences between valerian and placebo after a single dose or after 2 weeks of nightly dosing on any measure of sleep latency, wake after sleep onset (WASO), sleep efficiency, and self-rated sleep quality. In comparing each treatment to baseline in separate comparisons, WASO significantly increased (+17.7 ± 25.6 min, p = .02) after 2 weeks of nightly valerian, but not after placebo (+6.8 ± 26.4 min, NS). Side effects were minor and did not differ significantly between valerian and placebo.ConclusionValerian did not improve sleep in this sample of older women with insomnia. Findings from this study add to the scientific evidence that does not support use of valerian in the clinical management of insomnia.     

Maternal cognitions and depression in childhood behavioral insomnia and feeding disturbances

ObjectivesTo investigate (1) maternal cognitions regarding infant’s sleep and feeding and maternal depression among mothers of children with behavioral insomnia, feeding disturbances and healthy controls, and (2) the association between maternal cognitions about sleep and those about feeding.MethodsChildren 6–36 months of age with either behavioral insomnia or feeding disorders were recruited. Children 6–36 months of age who attended the well-baby clinics were recruited and served as controls. The participants’ mothers completed three questionnaires on their cognitions/perceptions of their child’s sleep and feeding habits and about their own feelings of depression.ResultsA total of 230 children (31 with behavioral insomnia, 29 with feeding disorders, 170 controls) were enrolled. Their mean age was 16.1 ± 7.6 months. Maternal cognitions/perceptions about sleep (maternal cognition infant sleep questionnaire, MCISQ) did not differ significantly between the behavioral insomnia group and the feeding disorders group. The MCISQ score was significantly higher in the behavioral insomnia group compared with controls (P < .02). Mothers of children with feeding disorders reported being significantly more frustrated or anxious when they fed their child (P < .0005), less confident about their child getting enough food (P < .0005), and less confident in their ability to manage their child’s behavior at mealtime (P < .02) compared to the controls. Significant positive correlations were found between the MCISQ scores and the Beck Depression Inventory scores (r = 0.29, P < .0002), and between the MCISQ scores and the maternal cognitions of their child’s feeding scores (r = 0.26, P < .0002). The latter remained significant after controlling for maternal depression (r = 0.25, P < .002).ConclusionsMothers of children with either behavioral insomnia or feeding disorders differ significantly from mothers of controls regarding their cognitions about sleep and feeding. Maternal cognitions about infant sleep behavior correlated with their cognitions about infant feeding. Maternal cognitions are a modifiable factor that may serve as a target for intervention in both sleep and feeding disorders in children.