Methylphenidate use was significantly associated with sleep problems and several different types of insomnia, according to a meta-analysis published in Journal of Clinical Psychiatry.
Although FDA labels for methylphenidate medications include its association with sleep-related adverse events, the magnitude of this effect, as well as which types of sleep problems are specifically tied to its use, is less clear, Stephen V. Faraone, PhD, from the departments of psychiatry and of neuroscience and physiology, SUNY Upstate Medical University, Syracuse, and colleagues explained.
“Both the size of the effect and the type of sleep problems are important elements to consider in daily clinical practice when prescribers and patients balance the benefits and the risk associated with methylphenidate,” they wrote.
To better understand methylphenidate-related sleep issues and study design-related confounders that affect the risk for such issues, the researchers conducted a systematic review and meta-analysis of blinded placebo-controlled studies examining youth with ADHD. Sleep-related adverse events included insomnia (general), initial insomnia, middle insomnia, terminal insomnia, combined insomnia, early morning awakening and sleep disorder
Analysis included 35 studies yielding 75 observations of sleep-related adverse events, which included 3,079 drug-exposed and 2,606 placebo-treated patients.
Pooled data indicted significantly increased risk for methylphenidate-associated sleep-related adverse events for general insomnia (RR = 1.61; P < .001), initial insomnia (RR = 2.78; P < .001), middle insomnia (RR = 2.97; P < .001), combined insomnia (RR = 2.97; P < .001), and sleep disorder (RR = 1.99; P < .001).
The researchers also found that potential confounders were mean age, percentage of males and percentage of stimulant responders in a sample; year of publication; number of study sites; using stabilization/optimization during dosing period; rater of adverse events and using a rating scale to obtain adverse events. After adjusting for confounders, Faraone and colleagues found significant differences among drugs for initial insomnia, general insomnia and sleep disorder (P < .0001), according to the results.
“Our work has implications for future clinical trial designs. Given that insomnia occurs with all methylphenidate products, studies would be more informative if they reported results for different classes of insomnia rather than lumping all types of insomnia under one nonspecific term,” they wrote. “Insomnia and other sleep [adverse events] should be routinely reported, and study reports should provide sufficient data for inclusion in future meta-analyses.” – by Savannah Demko
Disclosure: The authors report numerous relevant financial disclosures; please see the full study.