Armodafinil to reduce the sleepiness related side-effects of sleep restriction therapy being used to treat insomnia disorder: An open label clinical trial pilot study compared with historical controls.

Sleep restriction therapy (SRT) is an effective stand-alone behavioural intervention for insomnia disorder. However, its daytime side effects, particularly sleepiness, may be troubling for patients and/or may be a necessary part of the patient's treatment journey. This pilot trial aims to explore the potential benefit of armodafinil, a wakefulness promoter. Patients were treated with SRT with open label adjunctive armodafinil (150 mg/day). Thirty-three patients from previous studies that have undergone exactly the same SRT intervention acted as controls. The primary outcome measure was the insomnia severity index (ISI), and secondary outcomes were the Epworth sleepiness scale, sleep restriction adherence scale (SRAS), and safety from baseline through to 12 weeks. We recruited 25 patients into the trial. Data for the primary end point (ISI at 12 weeks) was available for 20 of the participants. The baseline insomnia severity index was 20.2 (SD 3.3) and decreased to 9.1 (SE 1.1), with no change, to 10.2 and 11.2 at weeks 6 and 12 respectively (all p > 0.05 compared with baseline). The insomnia severity index values for armodafinil patients were statistically inferior to historical controls at the primary time point of 12 weeks (11.2 vs. 6.7, p < 0.01). Sleep restriction therapy plus armodafinil treatment was associated with frequent minor side effects but was generally safe and acceptable to patients. Sleep restriction therapy was associated with a robust clinical response in the insomnia severity index values for insomnia patients. Based upon historical control data, armodafinil does not appear to have beneficial adjunctive effects in addition to sleep restriction therapy alone.

Brain mitochondrial dysfunction and driving simulator performance in untreated obstructive sleep apnea.

It is challenging to determine which patients with obstructive sleep apnea (OSA) have impaired driving ability. Vulnerability to this neurobehavioral impairment may be explained by lower brain metabolites levels involved in mitochondrial metabolism. This study compared markers of brain energy metabolism in OSA patients identified as vulnerable vs resistant to driving impairment following extended wakefulness. 44 patients with moderate-severe OSA underwent 28hr extended wakefulness with three 90min driving simulation assessments. Using a two-step cluster analysis, objective driving data (steering deviation and crashes) from the 2nd driving assessment (22.5 h awake) was used to categorise patients into vulnerable (poor driving, n = 21) or resistant groups (good driving, n = 23). 1 H magnetic resonance spectra were acquired at baseline using two scan sequences (short echo PRESS and longer echo-time asymmetric PRESS), focusing on key metabolites, creatine, glutamate, N-acetylaspartate (NAA) in the hippocampus, anterior cingulate cortex and left orbito-frontal cortex. Based on cluster analysis, the vulnerable group had impaired driving performance compared with the resistant group and had lower levels of creatine (PRESS p = ns, APRESS p = 0.039), glutamate, (PRESS p < 0.01, APRESS p < 0.01), NAA (PRESS p = 0.038, APRESS p = 0.035) exclusively in the left orbito-frontal cortex. Adjusted analysis, higher glutamate was associated with a 21% (PRESS) and 36% (APRESS) reduced risk of vulnerable classification. Brain mitochondrial bioenergetics in the frontal brain regions are impaired in OSA patients who are vulnerable to driving impairment following sleep loss. These findings provide a potential way to identify at risk OSA phenotype when assessing fitness to drive, but this requires confirmation in larger future studies.

Predictors of weight loss in obese patients with obstructive sleep apnea.

PURPOSE: Consistent predictors of weight loss outcomes with very low-energy diets (VLEDs) in obstructive sleep apnea (OSA) have not been identified. This study aimed to identify variables predictive of weight loss success in obese patients with OSA undertaking an intensive weight loss programme. METHODS: We analysed biological, psychological, and behavioural variables as potential predictors of weight loss in obese patients with OSA after a 2-month VLED followed by one of two 10-month weight loss maintenance diets. Actigraphy, in-lab polysomnography, urinary catecholamines, and various psychological and behavioural variables were measured at baseline, 2, and 12 months. Spearman's correlations analysed baseline variables with 2-month weight loss, and 2-month variables with 2-12 month-weight change. RESULTS: Forty-two patients completed the VLED and thirty-eight completed the maintenance diets. Actigraphy data revealed that late bedtime (rs = - 0.45, p = < 0.01) was correlated with 2-month weight loss. The change in the time that participants got out of bed (rise-time) from baseline to two months was also correlated with 2-month weight loss (rs = 0.36, p = 0.03). The Impact of Weight on Quality of Life-Lite questionnaire (IWQOL) Public Distress domain (rs = - 0.54, p = < 0.01) and total (rs = - 0.38, p = 0.02) scores were correlated with weight loss maintenance from 2 to 12 months. CONCLUSIONS: Results from this small patient sample reveal correlations between actigraphy characteristics and weight loss in obese patients with OSA. We suggest the IWQOL may also be a useful clinical tool to identify OSA patients at risk of weight regain after initial weight loss. CLINICAL TRIAL REGISTRATION: This clinical trial was prospectively registered on 18/02/2013 with the Australia and New Zealand Clinical Trials Registry (ACTRN12613000191796). PUBLIC REGISTRY TITLE: Sleep, Lifestyle, Energy, Eating, Exercise Program for the management of sleep apnea patients indicated for weight loss treatment: A randomised, controlled pilot study. URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363680.

The Effectiveness of Digital Insomnia Treatment with Adjunctive Wearable Technology: A Pilot Randomized Controlled Trial.

OBJECTIVE: This pilot trial aimed to provide evidence for whether the integration of a wearable device with digital behavioral therapy for insomnia (dBTi) improves treatment outcomes and engagement. PARTICIPANTS AND METHODS: One hundred and twenty-eight participants with insomnia symptoms were randomized to a 3-week dBTi program (SleepFix®) with a wearable device enabling sleep data synchronization (dBTi+wearable group; n = 62) or dBTi alone (n = 66). Participants completed the Insomnia Severity Index (ISI) and modified Pittsburgh Sleep Quality Index (PSQI) parameters: wake-after-sleep-onset (WASO), sleep-onset-latency (SOL), and total sleep time (TST) at baseline and weeks 1, 2, 3, and primary endpoint of week 6 and follow-up at 12 weeks. Engagement was measured by the number of daily sleep diaries logged in the app. RESULTS: There was no difference in ISI change scores between the groups from pre- to post-treatment (Cohen's d= 0.7, p= .061). The dBTi+wearable group showed greater improvements in WASO (d= 0.8, p = .005) and TST (d= 0.3, p= .049) compared to the dBTi group. Significantly greater engagement (sleep diary entries) was observed in the dBTi+wearable group (mean = 22.4, SD = 10.0) compared to the dBTi group (mean = 14.1, SD = 14.2) (p = .010). CONCLUSIONS: This pilot trial found that integration of wearable device with a digital insomnia therapy enhanced user engagement and led to improvements in sleep parameters compared to dBTi alone. These findings suggest that adjunctive wearable technologies may improve digital insomnia therapy effectiveness.

The effect of daily aerobic cycling exercise on sleep quality during inpatient cannabis withdrawal: A randomised controlled trial.

Sleep disturbance is a common symptom encountered by cannabis-dependent individuals abstaining from cannabis use. In the present study, we investigated the effect of daily aerobic cycling exercise versus control stretching on sleep quality during inpatient cannabis withdrawal in treatment-seeking dependent cannabis users. The protocol incorporated three consecutive phases: a 4-Day (4-Night) (at-home) 'Baseline' phase, a 6-Day (5-Night) 'Treatment' phase (within a 7-Day inpatient hospital stay) and a 3-Day (4-Night) (at-home) 'Post-Treatment' phase. Participants performed 35 min of monitored activity per day during the Treatment phase. The intervention group (n = 19) cycled at ~60% aerobic capacity (VO2max ), while the control group (n = 12) performed a stretching routine. Objective sleep quality was measured nightly throughout the study using wrist actigraphy ratings of subjective sleep quality were also recorded during the Treatment phase. There were no group differences in sleep measures during the Baseline phase (all p > .05). Objective sleep onset latency increased from the Baseline to the Treatment phase in the control (stretching) group (p = .042). In contrast, the Cycling group exhibited improvements in sleep duration (p = .008) and sleep efficiency (p = .023) during the Treatment phase compared to the Baseline phase. Cycling also increased sleep duration (p = .005), decreased average wake bout (p = .040) and tended to increase sleep efficiency (p = .051) compared to stretching during the Treatment phase. Subjective sleep quality ratings did not differ between groups (p > .10). These preliminary findings suggest that moderate-intensity aerobic exercise may attenuate the sleep disturbances associated with cannabis withdrawal.

Does continuous positive airways pressure treatment improve clinical depression in obstructive sleep apnea? A randomized wait-list controlled study.

BACKGROUND: Obstructive sleep apnea (OSA) is a highly prevalent sleep disorder that is associated with a range of adverse daytime sequelae, including significantly higher rates of clinical depression than is seen in the general community. Improvements in depressive symptoms occur after treatment of the primary sleep disorder, suggesting that comorbid depression might be an intrinsic feature of OSA. However, there are limited data on whether treatment for OSA in patients diagnosed with clinical depression improves mood symptoms meaningfully enough to lead to the remission of the psychiatric diagnosis. METHODS: N = 121 untreated OSA patients were randomized to either continuous positive airway pressure (CPAP) treatment or waitlist control, and depressive symptoms, sleepiness and clinical depression (using a structured clinical interview) were assessed at baseline and 4 months. Linear and logistic regression analyses were conducted, controlling for baseline scores, stratification factors and antidepressant use. RESULTS: Depressive symptoms (odds ratio [OR] = -4.19; 95% confidence interval [CI] = -7.25, -1.13; p = .008) and sleepiness (OR = -4.71; 95% CI = -6.26, -3.17; p < .001) were significantly lower at 4 months in the CPAP group compared to waitlist. At 4 months, there was a significant reduction in the proportion of participants in the CPAP group meeting criteria for clinical depression, compared to the waitlist controls (OR = 0.06, 95% CI = 0.01, 0.37; p = .002). CONCLUSION: Treatment of OSA may be a novel approach for the management and treatment of clinical depression in those with comorbid sleep disordered breathing. Larger trials of individuals with clinical depression and comorbid OSA are needed.

Sleep EEG microstructure is associated with neurobehavioural impairment after extended wakefulness in obstructive sleep apnea.

PURPOSE: Using quantitative EEG (qEEG) analysis, we investigated sleep EEG microstructure as correlates of neurobehavioural performance after 24 h of extended wakefulness in untreated OSA. METHODS: Eight male OSA patients underwent overnight polysomnography (PSG) at baseline followed by 40 h awake with repeated performance testing (psychomotor vigilance task [PVT] and AusEd driving simulator). EEG slowing during REM and spindle density during NREM sleep were calculated using power spectral analysis and a spindle detection algorithm at frontal and central electrode sites. Correlations between sleep EEG microstructure measures and performance after 24-h awake were assessed. RESULTS: Greater EEG slowing during REM sleep was associated with slower PVT reaction times (rho = - 0.79, p = 0.02), more PVT lapses (rho = 0.87, p = 0.005) and more AusEd crashes (rho = 0.73, p = 0.04). Decreased spindle density in NREM sleep was also associated with slower PVT reaction times (rho = 0.89, p = 0.007). Traditional PSG measures of disease severity were not consistent correlates of neurobehavioural performance in OSA. CONCLUSIONS: Sleep EEG microstructure measures recorded during routine PSG are associated with impaired vigilance in OSA patients after sleep deprivation. SIGNIFICANCE: Quantitative brain oscillatory (or EEG)-based measures of sleep may better reflect the deleterious effects of untreated OSA than traditional PSG metrics in at-risk individuals. Trial Registration ACTRN12606000066583.

Framework for the Design Engineering and Clinical Implementation and Evaluation of mHealth Apps for Sleep Disturbance: Systematic Review.

BACKGROUND: Mobile health (mHealth) apps offer a scalable option for treating sleep disturbances at a population level. However, there is a lack of clarity about the development and evaluation of evidence-based mHealth apps. OBJECTIVE: The aim of this systematic review was to provide evidence for the design engineering and clinical implementation and evaluation of mHealth apps for sleep disturbance. METHODS: A systematic search of studies published from the inception of databases through February 2020 was conducted using 5 databases (MEDLINE, Embase, Cochrane Library, PsycINFO, and CINAHL). RESULTS: A total of 6015 papers were identified using the search strategy. After screening, 15 papers were identified that examined the design engineering and clinical implementation and evaluation of 8 different mHealth apps for sleep disturbance. Most of these apps delivered cognitive behavioral therapy for insomnia (CBT-I, n=4) or modified CBT-I (n=2). Half of the apps (n=4) identified adopting user-centered design or multidisciplinary teams in their design approach. Only 3 papers described user and data privacy. End-user acceptability and engagement were the most frequently assessed implementation metrics. Only 1 app had available evidence assessing all 4 implementation metrics (ie, acceptability, engagement, usability, and adherence). Most apps were prototype versions (n=5), with few matured apps. A total of 6 apps had supporting papers that provided a quantitative evaluation of clinical outcomes, but only 1 app had a supporting, adequately powered randomized controlled trial. CONCLUSIONS: This is the first systematic review to synthesize and examine evidence for the design engineering and clinical implementation and evaluation of mHealth apps for sleep disturbance. The minimal number of apps with published evidence for design engineering and clinical implementation and evaluation contrasts starkly with the number of commercial sleep apps available. Moreover, there appears to be no standardization and consistency in the use of best practice design approaches and implementation assessments, along with very few rigorous efficacy evaluations. To facilitate the development of successful and evidence-based apps for sleep disturbance, we developed a high-level framework to guide researchers and app developers in the end-to-end process of app development and evaluation.

A feasibility and acceptability study of cognitive behavioural treatment for insomnia in adolescents with traumatic brain injury: A-B with follow up design, randomized baseline, and replication across participants.

Difficulties falling asleep or staying asleep (symptoms of insomnia) are common following paediatric traumatic brain injury (TBI). Yet, interventions to treat insomnia in this population have not yet been reported. This single-case series examined the feasibility and acceptability of cognitive behavioral treatment for insomnia (CBT-I) for adolescents (n = 5, aged 11-13 years) with TBI, and explored changes in sleep and fatigue post-treatment. Adolescents were randomly assigned to two conditions: a 7- or 14-days baseline, followed by 4 weeks of manualised CBT-I delivered individually. To assess feasibility and acceptability we compared recruitment and retention rates, and questionnaire scores to a-priori set criteria. We explored treatment efficacy and functional gains in sleep and fatigue from baseline to follow-up using structured visual analysis of time-series graphs, and reliable change indices or changes in clinical classification. Feasibility and acceptability indicators met a-priori criteria, but therapists noticed limited adolescent engagement in sessions. Clinically significant improvements were found in sleep, in 3 out of 4 cases, and fatigue, in all cases. Our study provides preliminary evidence that CBT-I is feasible for insomnia treatment in adolescents with TBI and provides directions for development of future treatment studies.

A PERIOD3 variable number tandem repeat polymorphism modulates melatonin treatment response in delayed sleep-wake phase disorder.

We examined whether a polymorphism of the PERIOD3 gene (PER3; rs57875989) modulated the sleep-promoting effects of melatonin in Delayed Sleep-Wake Phase Disorder (DSWPD). One hundred and four individuals (53 males; 29.4 ±10.0 years) with DSWPD and a delayed dim light melatonin onset (DLMO) collected buccal swabs for genotyping (PER34/4 n = 43; PER3 5 allele [heterozygous and homozygous] n = 60). Participants were randomised to placebo or 0.5 mg melatonin taken 1 hour before desired bedtime (or ~1.45 hours before DLMO), with sleep attempted at desired bedtime (4 weeks; 5-7 nights/week). We assessed sleep (diary and actigraphy), Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Patient-Reported Outcomes Measurement Information System (PROMIS: Sleep Disturbance, Sleep-Related Impairment), Sheehan Disability Scale (SDS) and Patient- and Clinician-Global Improvement (PGI-C, CGI-C). Melatonin treatment response on actigraphic sleep onset time did not differ between genotypes. For PER34/4 carriers, self-reported sleep onset time was advanced by a larger amount and sleep onset latency (SOL) was shorter in melatonin-treated patients compared to those receiving placebo (P = .008), while actigraphic sleep efficiency in the first third of the sleep episode (SE T1) did not differ. For PER3 5 carriers, actigraphic SOL and SE T1 showed a larger improvement with melatonin (P < .001). Melatonin improved ISI (P = .005), PROMIS sleep disturbance (P < .001) and sleep-related impairment (P = .017), SDS (P = .019), PGI-C (P = .028) and CGI-C (P = .016) in PER34/4 individuals only. Melatonin did not advance circadian phase. Overall, PER34/4 DSWPD patients have a greater response to melatonin treatment. PER3 genotyping may therefore improve DSWPD patient outcomes.

Insomnia Management in the Australian Primary Care Setting.

BACKGROUND AND OBJECTIVE: Insomnia is one of the most prevalent and costly sleep disorders presenting in general practice, and when left untreated, has major health consequences. However, studies are limited on how general practitioners respond to this health issue, especially since the reconceptualization of insomnia in DSM 5. Therefore, the aim of this study was to explore how insomnia is diagnosed and treated in Australian general practices. PARTICIPANTS: Twenty-four (54% male) general practitioners were recruited throughout the greater Sydney metropolitan area in New South Wales using the professional network of research team members and snowballing technique. METHODS: Participants were interviewed using a semi-structured interview guide. The audio-taped interviews were transcribed verbatim and a framework approach was used for analysis of transcribed data. RESULTS: Participant's responses highlighted that despite being a frequent presentation, insomnia is often trivialized with a low recognition rate in general practices. Lack of support and clear and effective management guidelines for general practitioners are the perceived barriers to early recognition of insomnia in general practices. Treating the underlying causes and initiating the treatment with general practitioners to manage insomnia. Medications including off-label antidepressants are often prescribed based on perceived patient expectation for a prescription. CONCLUSION: Findings of this exploratory study suggest the need for clearly contextualized guidelines that include information about a patient's insomnia experience and treatment expectations. Another significant implication of this study is the need to develop and evaluate a model of collaborative sleep health services in general practice.

"Sleep Well, Think Well" Group Program for Mild Cognitive Impairment: A Randomized Controlled Pilot Study.

Objective/Background: Sleep-wake disturbance is associated with poor cognitive functioning and several other adverse outcomes that increase dementia risk in older adults. Targeting sleep-wake disturbance in individuals at risk for dementia may be an important treatment. This study evaluated the efficacy of a four-session multicomponent group intervention for participants with mild cognitive impairment (MCI). Participants: Thirty-five older adults with MCI (mean age = 69.7 years, SD = 9.1), were recruited. MCI was determined via consensus from neuropsychological, medical, and neurological review. Methods: Participants were randomized to the "Sleep Well, Think Well" (SWTW) group condition or a passive control group. The SWTW group received four fortnightly face-to-face sessions conducted by an experienced sleep psychologist and neuropsychologist. The control group received written material detailing strategies to improve sleep quality. Both groups received fortnightly coaching phone calls. The primary outcome was subjective sleep quality, measured by the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes included actigraphy sleep measures, daytime sleepiness, cognitive functioning, and depression severity. Results: The SWTW intervention was associated with a large and statistically significant improvement in subjective sleep quality (Cohen's d = 0.83, p < 0.02). A moderate nonsignificant effect was evident in reducing daytime sleepiness (Cohen's d = 0.70, p = .08). No significant effects were found on actigraphy markers, depressive symptoms, or tests of cognitive functioning. Conclusions: The eight-week SWTW group intervention for MCI significantly improved subjective sleep quality when compared with a passive control condition. The program also had a moderate (nonsignificant) effect on reducing daytime sleepiness.

Patient Perceptions of Treatment Delivery Platforms for Cognitive Behavioral Therapy for Insomnia.

OBJECTIVE: Stepped care has given rise to the proliferation of abbreviated CBT-I programs and delivery formats. This includes interventions delivered by allied health professionals and those delivered electronically through the Internet. This article aims to explore patient perceptions between electronic and face-to-face (FTF) delivery platforms for (abbreviated) CBT-I. PARTICIPANTS: Patients with insomnia from specialist sleep or psychology clinics and those from the general community in Sydney, Australia. METHOD: Semistructured interviews were conducted with patients with insomnia, guided by a schedule of questions and a choice task to explore patient perceptions of the different CBT-I treatment delivery platforms (e.g., perceived advantages and disadvantages or willingness to engage with either platform). Interviews were transcribed verbatim and analyzed using Framework Analysis. Participants also completed a battery of clinical mood and insomnia measures. RESULTS: Fifty-one interviews were conducted with patients with insomnia from specialist sleep or psychology clinics (n = 22) and the general community (n = 29). Synthesis of the qualitative data set revealed three themes pertinent to the patients' perspective toward electronic and FTF CBT-I delivery: Concepts of Efficacy, Concerns About Treatment, and Treatment on My Terms. Participants' choice to engage with either platform was also informed by diverse factors including perceived efficacy of treatment, personal commitments, lifestyle, and beliefs about sleep and insomnia. CONCLUSION: Clarifying patient treatment priorities and allaying potential concerns about engaging with an electronic treatment platform represent important steps for disseminating eCBT-I into mainstream practice.

Efficacy of melatonin with behavioural sleep-wake scheduling for delayed sleep-wake phase disorder: A double-blind, randomised clinical trial.

BACKGROUND: Delayed Sleep-Wake Phase Disorder (DSWPD) is characterised by sleep initiation insomnia when attempting sleep at conventional times and difficulty waking at the required time for daytime commitments. Although there are published therapeutic guidelines for the administration of melatonin for DSWPD, to our knowledge, randomised controlled trials are lacking. This trial tested the efficacy of 0.5 mg melatonin, combined with behavioural sleep-wake scheduling, for improving sleep initiation in clinically diagnosed DSWPD patients with a delayed endogenous melatonin rhythm relative to patient-desired (or -required) bedtime (DBT). METHODS: This randomised, placebo-controlled, double-blind clinical trial was conducted in an Australian outpatient DSWPD population. Following 1-wk baseline, clinically diagnosed DSWPD patients with delayed melatonin rhythm relative to DBT (salivary dim light melatonin onset [DLMO] after or within 30 min before DBT) were randomised to 4-wk treatment with 0.5 mg fast-release melatonin or placebo 1 h before DBT for at least 5 consecutive nights per week. All patients received behavioural sleep-wake scheduling, consisting of bedtime scheduled at DBT. The primary outcome was actigraphic sleep onset time. Secondary outcomes were sleep efficiency in the first third of time in bed (SE T1) on treatment nights, subjective sleep-related daytime impairment (Patient Reported Outcomes Measurement Information System [PROMIS]), PROMIS sleep disturbance, measures of daytime sleepiness, clinician-rated change in illness severity, and DLMO time. FINDINGS: Between September 13, 2012 and September 1, 2014, 307 participants were registered; 116 were randomised to treatment (intention-to-treat n = 116; n = 62 males; mean age, 29.0 y). Relative to baseline and compared to placebo, sleep onset occurred 34 min earlier (95% confidence interval [CI] -60 to -8) in the melatonin group. SE T1 increased; PROMIS sleep-related impairment, PROMIS sleep disturbance, insomnia severity, and functional disability decreased; and a greater proportion of patients showed more than minimal clinician-rated improvement following melatonin treatment (52.8%) compared to placebo (24.0%) (P < 0.05). The groups did not differ in the number of nights treatment was taken per protocol. Post-treatment DLMO assessed in a subset of patients (n = 43) was not significantly different between groups. Adverse events included light-headedness, daytime sleepiness, and decreased libido, although rates were similar between treatment groups. The clinical benefits or safety of melatonin with long-term treatment were not assessed, and it remains unknown whether the same treatment regime would benefit patients experiencing DSWPD sleep symptomology without a delay in the endogenous melatonin rhythm. CONCLUSIONS: In this study, melatonin treatment 1 h prior to DBT combined with behavioural sleep-wake scheduling was efficacious for improving objective and subjective measures of sleep disturbances and sleep-related impairments in DSWPD patients with delayed circadian phase relative to DBT. Improvements were achieved largely through the sleep-promoting effects of melatonin, combined with behavioural sleep-wake scheduling. TRIAL REGISTRATION: This trial was registered with the Australian New Zealand Clinical Trials Registry, ACTRN12612000425897.

To Drug or Not to Drug: A Qualitative Study of Patients' Decision-Making Processes for Managing Insomnia.

Treatment preferences play a key role in dictating sleep health outcomes. However, patients' treatment beliefs, attitudes, and experiences that inform preference conceptualization remain an unknown phenomenon. Therefore, this study aims to explore patient perceptions toward pharmacotherapy and the nonpharmacological management of insomnia. Fifty-one patients with insomnia were recruited from specialist clinics and general community settings. Participants completed a brief questionnaire followed by an in-depth semistructured interview that was digitally recorded, transcribed verbatim, and subjected to Framework Analysis to identify emergent themes. Three key themes were identified: Resolving Insomnia, Self-Imposed Treatment Boundaries, and Treatment Uptake. Patients' illness, treatment, and psychosocial beliefs and experiences are closely linked to treatment choice. Being attuned to these influences during the clinical encounter can facilitate treatment selection that is meaningful for the patient.

Mapping the illness trajectories of insomnia: a biographical disruption?

The insomnia illness experience can be conceptualised as a form of biographical disruption. Using a critical interpretive phenomenological lens 51 in-depth semi-structured interviews were conducted with patients from specialist sleep and psychology clinics (n = 22) and the general community (n = 29). Patients' narratives revealed key phases of their illness trajectories as they recognise, rethink and respond to insomnia. Their biographical events served as reference points for both patient groups to make sense of their illness experiences as they transitioned from a perceived state of sleeplessness to clinical insomnia. The innate biological process of sleep at night and the sleep-dependent daytime psychosocial function exerted a negative bi-directional effect, creating a continuous circuit of disruption. Coping mechanisms were inspired by the participants' immediate social environment and centred on sociocultural motifs of relaxation and alertness to break the 'circuit'. Access to specialist clinic services appeared to be contingent on the richness of resources in one's social network and surrounding environment rather than the clinical severity of the disease alone. Treatment that can simultaneously target the night time and daytime consequences of insomnia resonates closely with participants' depiction of insomnia as both a physiological and a psychosocial phenomenon.

People with insomnia: experiences with sedative hypnotics and risk perception.

BACKGROUND: Sedative hypnotics form an important part of managing insomnia and are recommended for short-term use. It is standard practice for clinicians to inform the patient to use medications only 'when required', but the use of these medications is often chronic. Little is known about the impact of standard labelling/instructions on promoting appropriate medication use for managing insomnia. OBJECTIVE: To explore patient medication-taking beliefs, experiences and behavioural practices relating to the use of pharmacological/complementary sleep aids for insomnia. SETTING AND PARTICIPANTS: Specialist sleep/psychology clinics and the general community in Sydney, Australia. METHOD: Semi-structured interviews were conducted with 51 people with insomnia using a schedule of questions to gauge their experiences, beliefs and current practices relating to insomnia medication use. Interviews were audio-recorded, transcribed verbatim and subjected to Framework Analysis to identify emergent themes. RESULTS: Participants held distinctive views about the safety and efficacy of complementary and pharmacological agents but do not intuitively turn to medications to resolve their sleep complaint. Medication use was affirmed through tangible medication-taking cues due to the ambivalence in current instructions and labelling. Practices such as dosage modification, medication substitution and delaying medication use might be important drivers for psychological dependence. CONCLUSION: Current labelling and instructions do not necessarily promote the quality use of sedative hypnotics due to the variability in patient interpretations. Clarifying the timing, quantity and frequency of medication administration as well as insomnia symptom recognition would play a significant role in optimizing the role of pharmacotherapy in the management of insomnia.

Treating Insomnia: A Review of Patient Perceptions Toward Treatment.

Patient views about their treatment for insomnia often dictate outcome. This review explores the literature relating to the patients' global perceptions toward treatment for insomnia. A strategic literature search was conducted using five databases (PubMed, CINAHL, Medline, PsycINFO, and Embase). The 57 research articles included for this review were mapped out chronologically across three key stages of treatment-seeking (pretreatment appraisal, actual treatment experiences, and posttreatment evaluation). Patient perceptions played an important role across these three key stages and influenced subsequent health behaviors such as the initiation of help-seeking, treatment uptake, treatment adherence, and treatment adjustment. Patients' perceptions toward treatment were heavily grounded by their psychosocial contexts. Clinical implications and future directions for including patient-centered metrics in mainstream practice and research are discussed.

Insomnia patients' help-seeking experiences.

Timely access to appropriate treatment is important for optimizing insomnia management. To date, little is known about insomnia patients' treatment experiences or how they access and engage with the available health care resources. This study sought to capture the help-seeking experiences and behavioral patterns of patients with insomnia who are seeking or receiving specialist care. A purposive sample of 26 insomnia patients from specialist sleep and mental health clinics located in metropolitan New South Wales, Australia was recruited. Participants completed a brief questionnaire, followed by an in-depth, semi-structured interview. Interviews were digitally recorded, transcribed verbatim, and analyzed using framework analysis. Three key themes emerged from the data: patients' sleep beliefs, treatment beliefs, and accessing specialized care. The findings show that daytime symptoms arising from insomnia serve as important illness cues for patients to seek medical help. In addition, participants' treatment pathways highlight factors that prevent the widespread use of cognitive behavioral therapy for insomnia (CBT-I), including limited awareness about CBT-I, tentative referral mechanisms, limited service providers, and the high cost of CBT-I.

Evaluating possible 'next day' impairment in insomnia patients administered an oral medicinal cannabis product by night: a pilot randomized controlled trial.

Cannabis and its major constituents, Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD), are being widely used to treat sleep disturbances. However, THC can cause acute cognitive and psychomotor impairment and there are concerns that driving and workplace safety might be compromised the day after evening use. Here, we examined possible 'next day' impairment following evening administration of a typical medicinal cannabis oil in adults with insomnia disorder, compared to matched placebo. This paper describes the secondary outcomes of a larger study investigating the effects of THC/CBD on insomnia disorder. Twenty adults [16 female; mean (SD) age, 46.1 (8.6) y] with physician-diagnosed insomnia who infrequently use cannabis completed two 24 h in-laboratory visits involving acute oral administration of combined 10 mg THC and 200 mg CBD ('THC/CBD') or placebo in a randomised, double-blind, crossover trial design. Outcome measures included 'next day' (≥9 h post-treatment) performance on cognitive and psychomotor function tasks, simulated driving performance, subjective drug effects, and mood. We found no differences in 'next day' performance on 27 out of 28 tests of cognitive and psychomotor function and simulated driving performance relative to placebo. THC/CBD produced a small decrease (-1.4%, p=.016, d=-0.6) in accuracy on the Stroop-Colour Task (easy/congruent) but not the Stroop-Word Task (hard/incongruent). THC/CBD also produced a small increase (+8.6, p=.042, d=0.3) in self-ratings of Sedated at 10 h post-treatment, but with no accompanying changes in subjective ratings of Alert or Sleepy (p's>0.05). In conclusion, we found a lack of notable 'next day' impairment to cognitive and psychomotor function and simulated driving performance following evening use of 10 mg oral THC, in combination with 200 mg CBD, in an insomnia population who infrequently use cannabis.