Efficacy
Clinical Efficacy in Adults With Insomnia (Including Those ≥65 Years of Age)
In 2 clinical trials with the 15-mg and 20-mg doses, BELSOMRA helped insomnia patients stay asleep longer1
Patients met DSM-IV criteria for the diagnosis of primary insomnia2:
- Waking up in the middle of the night, with difficulty getting back to sleep3
STUDY 1: DIFFERENCE IN TIME SPENT AWAKE AFTER SLEEP ONSET (WASO) AS MEASURED BY POLYSOMNOGRAPHY

- At Night 1, BELSOMRA 15 mg or 20 mg reduced WASO to 65 minutes, compared to 96 minutes with placebo (P<0.05)1
- In Study 2, from a baseline of 119 minutes, BELSOMRA 15 mg or 20 mg (n=145) reduced WASO to 61 minutes at Night 1, 72 minutes at Month 1, and 63 minutes at Month 3 (compared with a baseline of 118 minutes, 98 minutes at Night 1, 95 minutes at Month 1, and 93 minutes at Month 3 for placebo; n=286); P values were comparable with Study 11
Study design for Studies 1 and 2:
- Two similarly designed, 3-month, randomized, double-blind, placebo-controlled, parallel-group studies were conducted (Study 1 and Study 2). In both studies, non-elderly (ages 18–64) and elderly (ages ≥65) patients were randomized separately. For the studies together, non-elderly adults (mean age 46 years; 465 females, 275 males) were treated with BELSOMRA 20 mg (n=291) or placebo (n=449), and elderly patients (mean age 71 years; 346 females, 174 males) were treated with BELSOMRA 15 mg (n=202) or placebo (n=318).
In the same 2 clinical trials, with BELSOMRA 15-mg dose in patients ≥65 years of age
STUDY 1: ELDERLY SUBGROUP (≥65 YEARS) — DIFFERENCE IN TIME SPENT AWAKE AFTER SLEEP ONSET (WASO) AS MEASURED BY POLYSOMNOGRAPHY4
Phase 3 efficacy studies were not powered for elderly-only subgroup analyses and were not part of the multiplicity-controlled hypotheses for the trials.4 These data show the effect of BELSOMRA on the elderly and should not be used in a comparative manner to the overall population.

- At night 1, BELSOMRA 15 mg reduced WASO from baseline of 135 to 80 minutes vs reduction of 126 to 115 minutes for elderly patients receiving placebo4
- In Study 2, from a baseline of 132 minutes, BELSOMRA 15 mg (n=63) reduced WASO to 81 minutes at Night 1, 96 minutes at Month 1, and 81 minutes at Month 3 (compared with a baseline of 128 minutes, 119 minutes at Night 1, 122 minutes at Month 1, and 113 minutes at Month 3 for placebo; n=122)4
Methodology of Elderly Subgroup Analysis
While elderly patients were randomized in both Studies 1 and 2, the studies were not powered for elderly-only subgroup analysis and were not part of the multiplicity-controlled hypotheses for the studies. For the studies together, elderly patients (mean age 71 years; 346 females, 174 males) were treated with BELSOMRA 15 mg (n=202) or placebo (n=318). Additional limitations include:5
- Some patients were not evaluated for PSG4
- The trials used 15 mg in elderly patients. Recommended dose is 10 mg. If the 10-mg dose is well-tolerated but not effective, the dose can be increased. The maximum recommended dose of BELSOMRA is 20 mg once daily4
- Elderly patients (≥65 years old) were mostly 65–74 years of age (~80%). Patients were usually in good general health and had a diagnosis consistent with DSM-IV for primary insomnia. Patients with major depression or sleep-related breathing disorders, among others, were excluded4,5
In a clinical trial with the 10-mg dose, BELSOMRA improved sleep time vs placebo as measured by polysomnography6
- Night 1 baseline values for sleep efficiency (SE) and total sleep time (TST) were 65.1% (5h13m) for the BELSOMRA 10 mg group and 65.9% (5h16m) for the placebo group.
- Baseline values at Month 1 were 65.7% (5h15m) for the BELSOMRA 10 mg group, and 65.4% (5h14m) for the placebo group.
- BELSOMRA improved SE (based on TST to 82.9% (6h38m) at Night 1 and 84.4% (6h45m) at Month 1. SE (based on TST) was 76.8% (6h9m) at Night 1 and 77.8% (6h13m) at Month 1 for placebo. P<0.01 vs placebo at Night 1 and Month 1.
Study Design:
In a randomized, double-blind, placebo-controlled, 2-period (1 month per period with a single-blind washout between treatment periods 1 and 2) crossover polysomnography study, non-elderly adults with insomnia (ages 18-64) were treated with BELSOMRA at a dose of 10 mg (n=62) or 20 mg (n=61) in one period, and placebo in the other (n=249). The co-primary end points were SE, as derived from the PSG measure of TST, at Night 1 and at Month 1 of each period. (SE equals time asleep divided by time in bed multiplied by 100.)6
Clinical Efficacy for Insomnia in Patients with Mild to Moderate Alzheimer's Disease
Demonstrated efficacy and safety in an insomnia study in patients with mild to moderate Alzheimer’s disease (AD).
Patients treated with BELSOMRA exhibited a statistically significant improvement for both Total Sleep Time (TST) and Wake After Sleep Onset (WASO) measures, compared to those treated with placebo, as assessed by polysomnography at Week 4.

Patients received BELSOMRA 10 mg for approximately 14 days; of these, 77% had an increase to 20 mg for approximately 14 additional days.
- Use the lowest dose effective for the patient. For all BELSOMRA doses, take no more than once per night within 30 minutes of going to bed (with at least 7 hours remaining prior to planned awakening). Time to effect of BELSOMRA may be delayed if taken with or soon after a meal.
- The recommended dose for BELSOMRA is 10 mg, taken no more than once per night. If the 10 mg dose is well-tolerated but not effective, the dose can be increased. The maximum recommended dose of BELSOMRA is 20 mg taken no more than once per night.
- Exposure to BELSOMRA is increased in obese compared to non-obese patients, and in women compared to men. Particularly in obese women, the increased risk of exposure-related adverse effects should be considered before increasing the dose.
A randomized, double-blind, placebo-controlled, parallel-group, multi-site 4-week trial of BELSOMRA was conducted in patients with mild to moderate Alzheimer’s disease (n=285) for the treatment of insomnia. Male and female subjects aged 50-90 years (inclusive) were treated with BELSOMRA (n=142) or placebo (n=143).
References
1. Data available on request from Merck Professional Services-DAP, WP1, PO Box 4, West Point, PA 19486-0004. Please specify information package US-IMA-01367.
2. Data available on request from Merck Professional Services-DAP, WP1, PO Box 4, West Point, PA 19486-0004. Please specify information package US-IMA-01387.
3. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington, VA: American Psychiatric Association; 2013.
4. Data available on request from Merck Professional Services-DAP, WP1, PO Box 4, West Point, PA 19486-0004. Please specify information package US-IMA-01369.
5. Herring WJ, Connor KM, Snyder E, et al. Suvorexant in elderly patients with insomnia: pooled analyses of data from phase III randomized controlled clinical trials. Am J Geriatr Psychiatry. 2017;25:791-802.
6. Data available on request from Merck Professional Services-DAP, WP1, PO Box 4, West Point, PA 19486-0004. Please specify information package US-IMA-01363.