FORENSIC TOXICOLOGY

A four-week adult ADHD trial recorded more insomnia adverse events with lisdexamfetamine, while the overall sleep-quality score did not differ significantly from placebo. These results can coexist because they measure different aspects of experience.

What was measured

Adler and colleagues analyzed sleep in a randomized double-blind forced-dose study of 420 adults assigned to placebo or morning lisdexamfetamine at 30, 50 or 70 mg daily. The Pittsburgh Sleep Quality Index assessed seven components at baseline and four weeks. Spontaneously reported treatment-emergent adverse events supplied a separate source of sleep information.

The central result

The global sleep-score change did not significantly differ between pooled lisdexamfetamine and placebo groups (p = 0.33). The daytime-function component improved significantly, whereas the other six component comparisons were nonsignificant. Insomnia adverse events were reported in 19.3% of active-treatment participants versus 4.8% with placebo. A favorable daytime component therefore should not be summarized as universally improved sleep, and the global null comparison does not erase individual insomnia complaints.

Boundaries of the evidence

The sleep index was self-rated, not a polysomnographic recording. A group average can conceal benefit in some participants and difficulty in others. The trial’s short duration and forced-dose schedule limit conclusions about individually optimized long-term treatment. These data also do not establish effects in people without ADHD or after nonmedical methamphetamine use. Insomnia, daytime function and objective sleep architecture require different evidence. For interpreting a treatment account, preserve the assessment method and period rather than selecting either the questionnaire or adverse-event result as the only valid description.

Related evidence

See alertness and task performance during sleep deprivation.

Primary research

Original study: 10.1186/1744-9081-5-34.