Sublingual and oral zolpidem for insomnia disorder: a 3-month randomized trial.

ABSTRACT:

Objective

To evaluate the safety and efficacy of a 5 mg sublingual dose of zolpidem, compared to a 10 mg oral dose, at bedtime and "as needed" following middle-of-the-night awakenings.

Methods

Participants were randomized into an oral group (oral zolpidem 10 mg and sublingual placebo at bedtime and "as-needed") and a sublingual group (oral placebo and sublingual zolpidem 5 mg at bedtime and "as-needed"). Participants underwent medical evaluation, polysomnography, the psychomotor vigilance test, and completed questionnaires.

Results

Of 85 patients, 67 met the criteria for insomnia (48±10 years; 79% women) and were randomized. Of these, 46 completed 92±5 days of treatment. Mild-to-moderate adverse events were reported by 25% of the participants, including headache, slee

SUBMITTER: Castro LS 

PROVIDER: S-EPMC7115453 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature