Mydayis improves ADHD symptoms regardless of sleep issues

NEW YORK — Dose-optimized Mydayis, a once-daily mixed salts of a single-entity amphetamine product, improved symptoms and executive function in adults with ADHD with or without sleep-quality impairments at baseline, according to a poster presented here.

“[This] is the first study, to our knowledge, to inform clinicians of what they may expect in terms of stimulant treatment effects for ADHD when clients present with sleep complaints in addition to their ADHD,” Craig B. Surman, MD, of the department of psychiatry, Massachusetts General Hospital, told Healio Psychiatry.

“There is a large overlap of ADHD and sleep problems. We see a lot of individuals who have trouble getting around to going to bed, and who report poor sleep quality,” he continued. “This has been studied and demonstrated as a very common overlap in both children and adults. At the same time, medications that treat ADHD can also be wake-promoting, in other words, they may make it harder to fall asleep. To add an additional dimension of clinical concern, poor sleep quality impacts daytime function, so optimizing sleep is a clinical priority when trying to optimize the experience of individuals with ADHD.”

In their post-hoc 7-week, double-blind, dose-optimization study, Surman and colleagues randomly allocated adults with ADHD to receive Mydayis (12.5 mg to 75 mg) or placebo. They evaluated whether sleep quality at baseline would predict changes from baseline to endpoint in two subgroups of participants: sleep-quality impaired and sleep-quality not impaired. Adjustments were made for baseline age, BMI, lifetime insomnia and depression, and baseline outcome values.

In total, 132 patients in the intent-to-treat population received Mydayis and 132 received placebo.

Analysis showed that Mydayis outperformed placebo in both subgroups across Pittsburgh Sleep Quality Index component scores (P < .001 for all) in improving ADHD symptoms from baseline to endpoint: days dysfunctional due to sleepiness (impaired: –9.5; not impaired: –7.8), sleep disturbance (impaired: –10.6; not impaired: –6.8), and sleep latency (impaired: –7.7; not impaired: –8.8).

“The study found that individuals taking a long-acting amphetamine salt product — expected to provide 16 hours of coverage — self-reported significant improvement in both ADHD and related organizational challenges, as is expected from this kind of agent,” Surman said. “Our presentation at APA reflects a post-hoc analysis to demonstrate whether the presence of sleep problems before the start of treatment impacted whether we saw this improvement. This suggests that while clinicians should prioritize the syndrome they are most concerned about clinically, ADHD and related challenges can improve even in the setting of presenting sleep problems.”

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Mydayis also did better than placebo in improving executive function: days dysfunctional due to sleepiness (impaired: –18.7; not impaired: –15.7), sleep disturbance (impaired: –18.1; not impaired: –15.2), and sleep latency (impaired: –14.3; not impaired: –17.7).

“We need to do further study to understand whether there are particular patterns of sleep problems which predict how people will respond to treatment,” Surman told Healio Psychiatry. “The study has real-world implications: Clinicians can have some more confidence that when they see patients struggling with ADHD and sleep problems it is worth trying to treat the ADHD.”

Surman also highlighted that this research does not suggest clinicians should ignore sleep problems and that it is best to treat all presenting conditions.

“Re-evaluation of whether individuals meet full diagnostic criteria for ADHD, and whether they still benefit from ADHD medication, is important when a comorbid condition improves,” he said. – by Savannah Demko

Reference:

Surman CB, et al. Poster P8-133. Presented at: American Psychiatric Association Annual Meeting; May 5-9, 20178; New York.

Disclosures: Surman reports support from Shire as a speaker, consultant and for research, but no funding to support the conduct of the research reported at APA.