Efficacy and safety of low-dose trazodone hydrochloride for insomnia in patients with myasthenia gravis.

BACKGROUND

The management of insomnia in patients with myasthenia gravis (MG) poses a clinical challenge, as MG is a well-recognized contraindication to sedative-hypnotic agents. This retrospective study aimed to assess the efficacy and safety of low-dose trazodone hydrochloride for the management of insomnia in MG patients.

METHODS

Clinical data were collected from MG patients with comorbid insomnia who received low-dose trazodone hydrochloride (25-100 mg, once nightly, for ≥ 4 weeks). Enrolled patients were stratified into three groups based on Self-Rating Depression Scale (SDS) scores: pure insomnia group (SDS: 0-52), mild depression group (SDS: 53-62), and moderate-to-severe depression group (SDS ≥ 63). Changes in Pittsburgh Sleep Quality Index (PSQI) scores, SDS scores, and Myasthenia Gravis Activities of Daily Living (MG-ADL) scores before and after trazodone hydrochloride administration were analyzed.

RESULTS

Total 68 MG patients were enrolled, including 17 cases of ocular MG and 51 cases of mild generalized MG. Of these patients, 18 (26.5%) were assigned to the pure insomnia group, 30 (44.1%) to the mild depression group, and 20 (29.4%) to the moderate-to-severe depression group. Post-treatment PSQI scores were significantly reduced compared to baseline across all groups (all p < 0.01). The mild depression group exhibited a significant decrease in SDS scores after treatment (p < 0.01), whereas no significant reduction in SDS scores was observed in the moderate-to-severe depression group. No patients experienced an increase in MG-ADL scores. Mild adverse events were reported in 4 patients (5.9%), including hypotension (n = 2), dizziness (n = 1), and nausea (n = 1).

CONCLUSIONS

Low-dose trazodone hydrochloride demonstrates favorable efficacy and safety in improving insomnia in patients with stable and mild MG.