The daytime effects of insomnia pharmacotherapy may be overlooked when relying on standard patient-reported outcome measures, as shown in a randomized trial using smartphone-based ecological momentary assessment during treatment with suvorexant.
Researchers found that older adult participants with chronic insomnia who were treated with suvorexant showed time-of-day–specific changes in fatigue and cognition that weren't detected by standard retrospective questionnaires, despite improvements in overall insomnia severity.
In the double-blind trial, the researchers enrolled 40 participants aged 60 to 85 years with moderate to severe insomnia and randomly assigned them to receive suvorexant or placebo for 16 nights. The participants completed conventional outcome scales prior to and folllowing treatment, alongside repeated smartphone-based ecological momentary assessment (EMA) surveys assessing daytime insomnia symptoms four times daily.
Using traditional retrospective questionnaires, suvorexant was found to reduce insomnia severity compared with placebo, but no between-group differences were detected for daytime fatigue, mood, or cognition. In contrast, EMA revealed significant treatment-related differences at specific times of day. Compared with placebo, suvorexant was associated with greater morning fatigue and reduced alert cognition earlier in the day, but lower fatigue and sleepiness later in the afternoon and evening.
EMA detected time-of-day–specific treatment effects, while high completion rates supported the feasibility of smartphone-based symptom tracking in this older adult population.
The researchers suggested that reliance on retrospective questionnaires alone may obscure clinically relevant daytime effects, particularly when such effects may fluctuate throughout the day. Among clinicians, the findings may have implications for evaluating patient response to treatment, balancing perceived benefits against adverse effects, and making informed decisions about ongoing medication use.
The participants receiving suvorexant also reported numerically poorer moods across the day, although the differences weren't statistically significant. The researchers cautioned that these findings warrant further study, especially given prior reports linking orexin antagonists to mood-related effects.
While limited by sample size and duration, the researchers concluded that EMA could offer an effective approach for refining outcome measurement in insomnia research and clinical care, potentially supporting more nuanced, patient-centered treatment decisions.
"EMA was sensitive to effects of insomnia treatment on daytime insomnia symptoms, a critical gap in the literature. [The] results supported continued refinement of EMA in sleep and psychiatric research and clinical care," stated lead study author Emerson M. Wickwire, PhD, of the Division of Pulmonary, Critical Care, and Sleep Medicine in Department of Medicine at the University of Maryland School of Medicine, and colleagues.
The researchers concluded that broader adoption of EMA could improve the evaluation of insomnia therapies and support more nuanced, patient-centered treatment decisions.
Disclosures: Dr. Wickwire reported receiving personal fees from DayZz, Eisai, EnsoData, Isorsia, Merck, Nox Health, Primasun, Purdue, and ResMed and grants from ResMed outside the submitted work. Dr. Wickwire also reported being the inventor of and shareholder in WellTap. Co–study author Timothy A. Steenbergh, PhD, reported being a cofounder and equity holder of LifeData LLC. Co–study author Daniel J. Buysse, MD, reported receiving personal fees from use of the Daytime Insomnia Symptoms Scale outside the submitted work. The study authors reported no other disclosures.
Source: JAMA Network Open
