Demographics of patients in Germany

This analysis included data from a total of 83 patients with OSA and associated EDS treated with solriamfetol. Mean (SD) age was 49 (14) years, 65% were male, and mean (SD) body mass index (BMI) was 32.2 (6.0) kg/m2 (Table 1). Of 76 patients who reported at least 1 comorbidity, the most common comorbidities included Obesity (58%), hypertension (49%) and anxiety/depression (30%). Overall, 73 patients (88%) used PAP therapy; 60 (72%) and 66 (80%) used PAP ≥ 4 h/night and ≥ 4 nights/week, respectively. New-to-therapy was the most common initiation strategy (n = 62, 75%), followed by add-on (n = 12, 14%) and changeover (n = 9, 11%). At baseline, mean (SD) ESS scores were 16.0 (3.2) overall and 16.6 (2.0), 16.3 (3.8), and 15.9 (3.2) in the changeover, add-on, and new-to-therapy subgroups, respectively.

Table 1 Baseline demographic and clinical characteristicsPrior and concomitant medications for EDS

Overall, 30 patients reported prior use of medications for EDS (those taken any time before solriamfetol initiation; patients may have taken ≥ 1 of the medications listed), including 9 patients (75%) in the add-on subgroup, 9 patients (100%) in the changeover subgroup, and 12 patients (19%) in the new-to-therapy subgroup. The most common prior medications were pitolisant (n = 21, 70%), reported in 7/9 (78%), 8/9 (89%), and 6/12 patients (50%) in the add-on, changeover, and new-to-therapy subgroups who reported prior use of EDS medications, respectively, and modafinil (n = 12, 40%), reported in 2/9 (22%), 3/9 (33%), and 7/12 patients (58%) in the add-on, changeover, and new-to-therapy subgroups, respectively. Four patients (13%) reported use of other (nonspecified) medications (changeover, n = 1; new-to-therapy, n = 3).

Patients in the changeover group switched to solriamfetol from pitolisant (6 [67%]) or modafinil (1 [11%]); the switch from medication could not be determined in 2 patients (22%).

At the time of solriamfetol initiation, patients in the add-on group were taking pitolisant (7 [58%]), modafinil (2 [17%]) and other (nonspecified) medications (3 [25%]), and patients in the changeover group were taking modafinil (1 [11%]), pitolisant (2 [22%]), and other (nonspecified) medications (1 [11%]).

Factors considered for solriamfetol initiation

When deciding to initiate solriamfetol treatment, the most commonly considered factor was patient comorbidities (n = 29, 35%), followed by prior medications (n = 20, 24%) and comedications (n = 11, 13%); physicians reported no specific influencing criteria for 45 patients (54%). Age, sex, and BMI were also cited as factors considered when initiating solriamfetol.

All 9 patients in the changeover group switched to solriamfetol because of lack of efficacy of prior medications; changeover was managed with an abrupt switch to solriamfetol from patients’ prior medications.

Initiating and titrating solriamfetol

98% of solriamfetol prescriptions were written for once-daily administration. The most common starting dosage of solriamfetol was 37.5 mg/day, followed by 75 mg/day (Fig. 1). Solriamfetol was titrated in 54 patients (65%), most of whom (n = 30, 56%) completed titration within 2 weeks; of those titrated, 48% (n = 26) completed titration within 7 days. All patients completed titration as prescribed.

Fig. 1

Starting Doses of Solriamfetol

Change in ESS scores

Mean (SD) time from solriamfetol initiation to final follow-up was 15.6 (6.6) weeks overall (n = 82), which generally was consistent across therapy subgroups: changeover (n = 9), 13.8 (6.0) weeks; add-on (n = 12), 14.7 (5.9) weeks; new-to-therapy (n = 61), 16.0 (6.8) weeks.

The overall mean (SD) ESS score was 16.0 (3.2) at solriamfetol initiation, which decreased to 10.7 (3.9) at follow-up (mean [SD] decrease from baseline of 5.4 [3.6, p <.001]) (Fig. 2). Changes in ESS scores generally were consistent across subgroups, with mean (SD) decreases from solriamfetol initiation to final follow-up of 5.5 (2.9, p =.001) in the changeover group, 5.7 (4.8, p =.008) in the add-on group, and 5.3 (3.6, p <.001) in the new-to-therapy group.

Fig. 2

Mean Decreases in ESS Scores With Solriamfetol

Patient- and physician-reported change in symptoms

Most patients (n = 74, 90%) reported strong (n = 38, 46%) or slight (n = 36, 44%) improvement in EDS-related symptoms from solriamfetol initiation to final follow-up; this finding generally was consistent across the subgroups (Fig. 3). Similarly, physicians reported strong or slight improvement in EDS for 89% (n = 73) of patients (Fig. 3). Patients and physicians reported no improvement for the remaining patients (n = 8 and n = 9, respectively; data unavailable for 1 patient); there were no patient or physician ratings of slight or strong worsening of symptoms.

Fig. 3

Physician and Patient Perceptionsa of Improvement in EDS

Patient-reported duration of effects

Most patients overall (n = 45, 55%) and by initiation strategy (changeover, n = 6, 67%; add-on, n = 6, 50%; new-to-therapy, n = 33, 54%) reported that the effects of solriamfetol lasted ≥ 8 h. Across initiation strategies, 24 patients (29%) reported they perceived the effects of solriamfetol lasting 8 to < 10 h, while 21 (26%) reported effects lasting ≥ 10 h (Fig. 4).

Fig. 4

Patient-Reported Duration of Effects of Solriamfetol

Overall, patients were not equally likely to endorse no wearing off, gradual wearing off or abrupt wearing off (p <.001). The majority (50%, n = 41) of patients reported no wearing off of solriamfetol at the end of the day, and 41% (n = 34) reported a gradual decrease of the therapeutic effects of solriamfetol; only 4% (n = 3) reported abrupt wearing off. Responses were unknown for 5% (n = 4) of patients. Findings generally were consistent across initiation strategies.

Patient-reported nighttime sleep quality

Overall, 75 patients (91%) reported their nighttime sleep quality did not meaningfully change after solriamfetol initiation (changeover, n = 8, 89%; add-on, n = 10, 83%; new-to-therapy, n = 57, 93%); however, some patients reported that sleep improved (changeover, n = 1, 11%; add-on, n = 1, 8%) or worsened (new-to-therapy, n = 3, 5%).

Adverse events

A total of 27 patients (33%) reported an adverse event. The most frequent adverse events were headache (9%), decreased appetite (7%), and insomnia (6%). Headache and decreased appetite were reported across initiation strategies, whereas insomnia was reported only in the new-to-therapy subgroup (Table 2). Increased blood pressure (n = 1, 2%) and increased heart rate (n = 1, 2%) were reported in the new-to-therapy subgroup.

Table 2 Treatment-emergent adverse Eventsa