Treatment of RLS with Horizant Reduces Nighttime Agitation & Improves Sleep in Patients with Dementia

Study results showed improved sleep and a reduction in nighttime agitation in dementia patients with restless legs syndrome (RLS) treated with Horizant (gabapentin enacarbil; Azurity Pharmaceuticals, Woburn, MA). These results were presented at the 2024 SLEEP meeting of the Associated Professional Sleep Societies.

The 8-week, double-blind, randomized trial included 147 older adults (mean age 83.4 ± 9.1 years) with dementia due to Alzheimer disease, nighttime agitation, and RLS. Participants received either Horizant, a Food and Drug Administration (FDA)-approved treatment for RLS, or placebo. Agitation was assessed using the Cohen-Mansfield Agitation Inventory (CMAI), and sleep was measured using actigraphy.

• There was a significant reduction in nighttime agitation in participants treated with Horizant at 2 weeks (P=.002) and 8 weeks (P=.004).
• There was a significant improvement in total sleep time in participants treated with Horizant at 8 weeks (P=.026), but not 2 weeks (P=.091).

The number of individuals having one or more adverse events was 81.1% in the Horizant group and 68.5% in the placebo group. The Horizant group had more falls than the placebo group (mean, 1.3 vs 0.7; P=.066).