Efficacy
Clinical efficacy in patients with insomnia and mild to moderate Alzheimer's disease (AD)
A prescription sleep medication with demonstrated efficacy and safety in an insomnia study in patients with mild to moderate Alzheimer’s disease.
In this study, patients treated with BELSOMRA® (suvorexant) 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.
Polysomnographic assessment of TST in patients with mild to moderate AD1,a
Model-based LS mean change from baseline at Week 4
aThe primary endpoint was change from baseline in polysomnography-derived total sleep time (TST) at Week 4.
LS, least squares.
In the same clinical study, polysomnographic assessment of WASO (sleep maintenance) in patients with mild to moderate AD1,b
Model-based LS mean change from baseline at Week 4
bThe secondary endpoint was change from baseline in polysomnography-derived wake after persistent sleep onset (WASO) 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.
Data from a 4-week randomized, double-blind, placebo-controlled, parallel-group, multi-site study. Two hundred eighty-five patients with mild to moderate Alzheimer’s disease for the treatment of insomnia were randomized; male and female subjects aged 50-90 years (inclusive) were treated with BELSOMRA (n=142) or placebo (n=143). The primary endpoint was change from baseline in polysomnography-derived total sleep time at Week 4.1
- Patients were randomized to BELSOMRA 10 mg (and could be increased to 20 mg after 14 days) or placebo1
- Patients treated with BELSOMRA received 10 mg for approximately 14 days; of these, 77% had an increase to 20 mg for approximately 14 additional days
- Eligible patients met diagnostic criteria for both AD and insomnia characterized by difficulties with sleep onset and sleep maintenance1
- Patients were screened over a 3-week period (inclusive of placebo run-in) prior to the 4-week treatment period, with 2-week follow-up1
- Overnight PSGs (polysomnography) were performed at 3 different time points: screening visit 14 days before randomization, baseline visit 7 days before randomization, and at the end of Week 4 treatment period1
- At baseline, patients experienced mean total sleep time of less than 6 hours and had a Mini-Mental State Exam (MMSE) score of 12–261
1. Herring WJ, Ceesay P, Snyder E, et al. Polysomnographic assessment of suvorexant in patients with probable Alzheimer’s disease dementia and insomnia: a randomised trial. Alzheimers Dement. 2020;16(3):541-551.