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.

Pharmacists' perceptions and communication of risk for alertness impairing medications.

BACKGROUND: A core role of the pharmacist is to ensure safe and effective medication use. Therapeutic classes that impair alertness (e.g. sedatives or hypnotics) can pose safety concerns for the consumer when undertaking activities requiring psychomotor vigilance (e.g. driving). OBJECTIVE: To explore pharmacists' perceptions and communication strategy of the risks related to alertness impairing medications in clinical practice. METHODS: In-depth semi-structured interviews explored community pharmacists' perceptions of medication-related risks, current medication provision and the feasibility of new practice tools. Interviews were digitally recorded, transcribed verbatim and analysed using Framework Analysis to identify emergent themes. A Psychometric Risk Perception Questionnaire was also used to evaluate pharmacists' perceptions across 7 common psychotropic drug classes. RESULTS: Synthesis of the qualitative dataset of 30 pharmacist interviews revealed three key themes: 'Safety and Consequences of AIMs', 'Factors that Influence Risk Communication' and 'Refining Risk Communication'. Participating pharmacists were generally aware of the therapeutic classes associated with medication-related risks but were concerned about patients' level of understanding. Counselling approaches were largely dictated by perceived patient interest/experience with a medication. Concerns were centred on inter-individual pharmacokinetic differences, which could make the precise risk assignment difficult. Pharmacists also highlighted workflow limitations and the need to bring patients' attention to these resources during the clinical interaction to maximise impact. CONCLUSIONS: Medication-related risk communication is a complex clinical phenomenon dictated by patients' prior experiences and the pharmacists' practice environment. Extending the evidence base in this therapeutic area and refining clinical resources are key steps towards optimising patient medication safety.