A Review of the Efficacy and Saftey of using Belsomra® in treating Insomnia in Alzheimer's Patients
Insomnia—struggling to fall asleep or stay asleep—is a widespread and challenging condition in adults over 65. This is largely due to normal, age-related changes in sleep patterns. Cognitive Behavioral Therapy for Insomnia (CBT-I) is strongly endorsed as the gold-standard, first-line treatment for , whenever feasible. While medications are often seen as easier, sleep drugs pose increasing risks with age—like drowsiness, confusion, or falls. Even if medication is needed, routines matter most. Here are some caregiver tips:
🌙 Healthy Sleep Routines That Help
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Keep bed and wake times consistent every day.
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Make the bedroom quiet, dark, and cool.
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Avoid caffeine after lunch.
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Encourage daylight exposure and gentle activity during the day.
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Use the bed only for sleep (and intimacy)—not TV or phones.
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Limit naps to 20–30 minutes early in the day.
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When CBT-I alone isn’t enough, medications like low-dose doxepin, melatonin, ramelteon, or newer ones like suvorexant (Belsomra) can help—but each comes with potential risks here in older bodies. Belsomra is the brand name for suvorexant, a medication classified as a dual orexin receptor antagonist (DORA). It helps promote sleep by blocking orexin, a brain chemical that supports wakefulness. It’s approved in adults—including older adults—for treating insomnia involving trouble falling asleep or staying asleep. In February 2020, the FDA updated Belsomra’s labeling to include findings from a 4-week randomized, placebo-controlled trial in people with mild to moderate Alzheimer’s disease.
HOW LARGE WAS TREATMENT EFFECT?
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In the Alzheimer's study (285 participants), those taking suvorexant experienced a greater improvement in total sleep time (TST)—73 minutes increase versus 45 minutes on placebo—a difference of 28 minutes, statistically significant.
number needs to treat (nnt)
- Unfortunately, this AD-specific study did not publish NNT (Number Needed to Treat) or NNH (Number Needed to Harm). However, broader insomnia data in older adults offer context:
- A recent review in the Cleveland Clinic Journal of Medicine (2025) reported for people 65 and older with insomnia:
- NNT = 8, which means: On average, treating eight people with insomnia with suvorexant results in one person benefiting versus placebo.
- For comparison, lemborexant (another DORA): NNT = 3
number needed to harm(NNH)
- The “harms” being tracked were dizziness, headaches, abnormal dreams, falls (noted especially in AD study), dry mouth, sleepwalking, sleep-driving, and next-day impairment—especially if taken too late, at high doses, or with other sedatives. While the exact NNH wasn’t published, you could roughly estimate it from those percentages:
- Somnolence: NNH ≈ 33
- Falls: NNH ≈ 50
- But these are approximate and from a single 4-week trial—so much less precise than the general insomnia data
- Broader insomnia data from Cleveland Clinic Journal of Medicine, 2025:
- Excessive daytime sleepiness: NNH= 13, taking suvorexant, verse NNH greater than 10 taking lemborexant
(Note: These NNT/NNH numbers are general to older adults with insomnia—not specific to Alzheimer’s patients—but still helpful for understanding treatment benefit versus risk.)
How soon Does belsomra start working?
- To maximize the medication's effectiveness, it's best to take it on an empty stomach or with a low-fat snack.
- It's also crucial to ensure you have at least 7 hours available for sleep after taking Belsomra, as it stays active in your system for several hours, and waking up before the medication has sufficiently worn off can lead to next-day drowsiness.
Alzheimer's-Related Insights: More Than Sleep?
- A preliminary, small study in healthy middle-aged adults (not Alzheimer’s patients) showed that suvorexant lowered Alzheimer’s-related proteins—specifically amyloid-beta and phosphorylated tau—in the brain’s fluid after two nights of dosing, compared to placebo.
- High dose (20 mg) led to a 10–20% drop in amyloid, 10–15% drop in tau.
- Encouraging but early—not enough evidence to support using Belsomra to prevent or slow Alzheimer’s
in summary
- Belsomra may offer meaningful sleep improvement for seniors with Alzheimer’s-related insomnia. The benefit (extra sleep) is real—but it's modest, and the potential risks, especially at home, are important to watch (falls, disorientation, complex behaviors).
- Before considering starting a medication for insomina, try cognitive behavioral therapy first.
- If you want to start medications, always consult the treating physician or geriatric specialist to consider if low-dose doxepin, melatonin/ramelteon, or DORAs like Belsomra are the best medication choice for treating insomnia for your loved one
- If provider and you agreed to try Belsomra:
- Start at the lowest effective dose.
- Time doses so that ample sleep time remains before morning activities.
- Watch carefully for side effects, especially increased sedation or unusual nighttime actions.
- Continue to practice good sleep hygiene (quiet setting, consistent routine, avoiding caffeine, etc.).