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Study Objectives: <p>Sleep-disordered breathing is incompletely characterized by the apnea-hypopnea index. Although typically viewed as milder disease, snoring and flow limitation can yield major deficits in sleep health for both patients and their bed partners. Here we tested whether a combined noradrenergic and antimuscarinic intervention to activate pharyngeal muscles yields improved snoring loudness and flow limitation severity, plus self-reported outcomes, by snorers and their bed partners.</p> Methods: <p>In a randomized placebo-controlled double-blind crossover study, adults with loud habitual snoring took atomoxetine plus oxybutynin for 10 days before bedtime at full adult doses (80 and 5 mg, respectively; half-dose run-in on days 1–3) and at half-doses (40 and 2.5 mg, respectively). Baseline polysomnography with tracheal sound recording established baseline snoring (mean loudness &gt; 75 dB) and an apnea-hypopnea index of &lt; 15 events/h. Mixed models compared full and half-doses to placebo in snoring loudness, flow limitation, and snoring self-evaluation and bed-partner evaluation scores, adjusting for baseline and period effects (intention-to-treat analysis).</p> Results: <p>Fifteen participants were randomly assigned and 13 completed all treatment periods. Snoring loudness was reduced with full dose (−9.3 [−19.6, −2.9] dB; difference [95% confidence interval]) and half-dose (−9.0 [−17.8, −3.2] dB) vs placebo (102.2 dB), equivalent to a two-thirds reduction in snoring amplitude. Flow-limitation severity was also meaningfully reduced (both doses). The Snoring Bed-Partner Evaluation Scale was reduced with the half-dose only (−2.8 [−5.3, −0.4] points from 10.1 on placebo). Self-evaluation scores were lowered exclusively in 7 of the 15 participants with bothersome snoring at baseline (treatment × subgroup interactions).</p> Conclusions: <p>In patients with habitual snoring, atomoxetine plus oxybutynin at half- and full doses improves snoring and flow limitation. A half-dose may also improve bed-partner outcomes.</p> <p><b>Clinical Trial Registration:</b> Registry: ClinicalTrials.gov; Name: Pharmacological Intervention for Symptomatic Snoring; URL: <a href="https://clinicaltrials.gov/study/NCT03720353">https://clinicaltrials.gov/study/NCT03720353</a>; Identifier: NCT03720353.</p> Citation: <p>Calianese N, Hess LB, Vena D, et&#xa0;al. Atomoxetine plus oxybutynin for symptomatic snoring and airflow limitation in individuals without moderate-to-severe obstructive sleep apnea. <i>J Clin Sleep Med.</i> 2025;21(9):1579–1590.</p>

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Atomoxetine plus oxybutynin for symptomatic snoring and airflow limitation in individuals without moderate-to-severe obstructive sleep apnea

  • 期刊论文

  • 发表日期：

    2025年9月1日

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  • Nicole Calianese,
  • Lauren B. Hess,
  • Daniel Vena,
  • Robert Konefal,
  • Dwayne L. Mann,
  • Luigi Taranto-Montemurro,
  • Suzanne M. Bertisch,
  • Tamar Sofer,
  • Ali Azarbarzin,
  • Laura K. Gell,
  • Scott A. Sands

摘要

Study Objectives:

Sleep-disordered breathing is incompletely characterized by the apnea-hypopnea index. Although typically viewed as milder disease, snoring and flow limitation can yield major deficits in sleep health for both patients and their bed partners. Here we tested whether a combined noradrenergic and antimuscarinic intervention to activate pharyngeal muscles yields improved snoring loudness and flow limitation severity, plus self-reported outcomes, by snorers and their bed partners.

Methods:

In a randomized placebo-controlled double-blind crossover study, adults with loud habitual snoring took atomoxetine plus oxybutynin for 10 days before bedtime at full adult doses (80 and 5 mg, respectively; half-dose run-in on days 1–3) and at half-doses (40 and 2.5 mg, respectively). Baseline polysomnography with tracheal sound recording established baseline snoring (mean loudness > 75 dB) and an apnea-hypopnea index of < 15 events/h. Mixed models compared full and half-doses to placebo in snoring loudness, flow limitation, and snoring self-evaluation and bed-partner evaluation scores, adjusting for baseline and period effects (intention-to-treat analysis).

Results:

Fifteen participants were randomly assigned and 13 completed all treatment periods. Snoring loudness was reduced with full dose (−9.3 [−19.6, −2.9] dB; difference [95% confidence interval]) and half-dose (−9.0 [−17.8, −3.2] dB) vs placebo (102.2 dB), equivalent to a two-thirds reduction in snoring amplitude. Flow-limitation severity was also meaningfully reduced (both doses). The Snoring Bed-Partner Evaluation Scale was reduced with the half-dose only (−2.8 [−5.3, −0.4] points from 10.1 on placebo). Self-evaluation scores were lowered exclusively in 7 of the 15 participants with bothersome snoring at baseline (treatment × subgroup interactions).

Conclusions:

In patients with habitual snoring, atomoxetine plus oxybutynin at half- and full doses improves snoring and flow limitation. A half-dose may also improve bed-partner outcomes.

Clinical Trial Registration: Registry: ClinicalTrials.gov; Name: Pharmacological Intervention for Symptomatic Snoring; URL: https://clinicaltrials.gov/study/NCT03720353; Identifier: NCT03720353.

Citation:

Calianese N, Hess LB, Vena D, et al. Atomoxetine plus oxybutynin for symptomatic snoring and airflow limitation in individuals without moderate-to-severe obstructive sleep apnea. J Clin Sleep Med. 2025;21(9):1579–1590.