Solriamfetol for Apnea-Related Sleepiness: TONES 3

If you still nod off during the day after a sleep-apnea diagnosis, describe when it happens and bring your treatment records to the next appointment. Ask the sleep team what it will check before considering a medicine for wakefulness.

What did TONES 3 measure?

TONES 3 randomized 476 adults with obstructive sleep apnea and excessive sleepiness to placebo or solriamfetol for 12 weeks, including adherent and nonadherent apnea-treatment users.¹

At 150 mg, the placebo-adjusted improvement was 10.7 minutes on the Maintenance of Wakefulness Test (95% CI 8.1–13.4) and 4.5 points lower on the Epworth Sleepiness Scale (95% CI −5.7 to −3.2). Coprimary outcomes measured wakefulness during 40-minute sessions and dozing propensity (0–24; lower better).¹

459 entered efficacy analyses; 404/474 treated participants completed. Models used available observations. Jazz Pharmaceuticals funded and supervised analyses. Long-term cardiovascular safety was not established.¹

What does the current prescription cover?

US Sunosi labeling requires treatment of the underlying airway obstruction for at least one month before starting, with that treatment continued. Sunosi does not replace it. The current maximum is 150 mg daily; the trial’s 300-mg arm does not authorize that dose in practice.²

A prescriber should check blood pressure, heart history, kidney function and interacting medicines. MAO inhibitors are contraindicated during treatment and for 14 days after stopping the MAOI. Blood pressure and pulse need monitoring; anxiety, insomnia or other psychiatric symptoms warrant contacting the prescriber. Headache and nausea are among common adverse effects. Discuss pregnancy or breastfeeding before use.²

What belongs in the next appointment?

NHLBI advises regular checkups to assess whether apnea treatment is working. Your clinician can review device data for use and effectiveness. Bring specific problems with the mask or device, rather than accepting discomfort without asking for help. PAP treatment should cover all sleep, including naps.³

Do not drive while tired or sleepy. Discuss driving safety separately at the appointment. Tell your clinician if sleepiness affects driving and arrange another way to travel.³

Did I Do That in My Sleep? includes “The First Treatment Conversation,” covering mask fit, pressure comfort, dryness and follow-up. Use those prompts to prepare a short account of what happens with your own equipment and who you will contact for help.