Largest-Ever Analysis of Ketamine Therapy for Sleep Shows 79% Response Rate Among 13,963 Mindbloom Patients

‍Summary:

Mindbloom conducted the largest retrospective real-world analysis of ketamine therapy for sleep to date, in which 13,963 patients reported outcomes matching or exceeding those reported in many studies of conventional sleep medications and psychotherapy. 

Highlights:

• Response rate: 79% of patients reported clinically meaningful sleep improvement (defined as ≥1-point improvement on PHQ-9 item 3)
• Magnitude of relief: On average, patients reported a 49% improvement in sleep disturbances
• Tolerability: 95% did not report side effects during treatment, with only 2.5% reporting any worsening of sleep disturbances

Methodology:

• Study Population: 13,963 patients who had moderate to severe sleep disturbances at baseline, defined as scores of 2 ("more than half the days") or 3 ("nearly every day") on PHQ-9 item 3. Mean baseline score was 2.55
• Treatment Protocol: Six guided at-home ketamine sessions completed over four to six weeks, supported by structured preparation, integration, and continuous clinician monitoring
• Outcome measure: Sleep disturbance was assessed using PHQ-9 item 3 ("Trouble falling or staying asleep, or sleeping too much"), a validated single-item measure directly capturing sleep disruption frequency. This item is widely used in clinical research and scored on a 4-point scale (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day)

How effective is Mindbloom ketamine therapy for sleep? 

Among the 13,963 Mindbloom patients analyzed, 79% reported at least a 1-point reduction on PHQ-9 item 3, which represents clinically meaningful improvement in self-reported sleep disturbance. Sleep scores improved 49% on average, suggesting considerable depth of improvement in addition to the breadth of those who responded.

To contextualize our findings, researchers applied validated anchor-based and distribution-based methods to compare response rates. Researchers mapped Mindbloom's PHQ-9 item 3 threshold against published data from conventional sleep treatments using different outcome measures, including the Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI) and MADRS item 4^1,2. Using this standardized comparison framework, Mindbloom's response rate was:

• 143% higher than melatonin study estimates^{3, 4, 5} 
• 50% higher than Z-drug^{6, 7, 8, 9, 10} and Trazodone^{11, 12, 13} study estimates
• 37% higher than Benzodiazepine study estimates^{14, 15}
• 17% higher than Cognitive Behavioral Therapy (CBT-I) study estimates^{16, 17, 18, 19}

This analysis suggests that Mindbloom’s at-home ketamine therapy may produce response rates exceeding those seen in studies of conventional medications, and comparable to or exceeding those seen in studies of the gold standard therapeutic approach.

Comparisons synthesize published data across randomized trials and real-world studies. See the full white paper for detailed methodology and sources. No head-to-head trials performed.

How safe is Mindbloom ketamine therapy for sleep? 

Tolerability was notably high across the Mindbloom cohort. Of the 13,963 clients analyzed, 95% did not report side effects during their treatment course. When side effects did occur—in just 5% of participants—they were typically mild and transient, including memory changes, GI discomfort, blood pressure changes, and headache.

Importantly, only 2.5% of participants reported that their sleep worsened during treatment, indicating that the intervention rarely led to deterioration of the primary concern.

This safety profile contrasts sharply with conventional sleep medications:

• Benzodiazepines carry dependency risks, with up to 23% of users becoming dependent within three months²⁰, plus increased fall and fracture risk²¹
• Z-drugs, (like Ambien and Lunesta), have been linked to 63% increased fracture risk²² and higher rates of motor vehicle collisions²³
• SSRIs have been linked to 60–70% higher insomnia likelihood in depression treatment²⁴
• Over-the-counter melatonin faces quality control issues, with 40% of U.S. products failing to meet acceptable dosing standards.²⁵

In addition, many sleep medications also suppress the deep and REM sleep stages critical for memory consolidation and physical recovery²⁶, offering unconsciousness but potentially impacting restoration. 

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Which ketamine therapy protocol produces better sleep outcomes: at-home or in-clinic?

While clinical research on ketamine therapy for sleep remains nascent relative to other psychiatric conditions, comparative analyses of different treatment protocols provide valuable insights into what may drive efficacy. This analysis examined two fundamentally different delivery approaches—at-home ketamine therapy with less frequent dosing versus clinic-based esketamine given more frequently³¹. At endpoint, Mindbloom patients in this analysis reported an average 49% improvement in sleep disruption, compared to 38% reported in a published esketamine study—suggesting faster response with fewer, less frequent total sessions.

The findings suggest that treatment accessibility and protocol efficiency need not be sacrificed for clinical efficacy, challenging the conventional assumption that intensive clinic-based administration is necessary for therapeutic benefit.

*This comparison maps Mindbloom's actual outcome data across measurable treatment stages against published esketamine outcomes at comparable treatment timepoints, with midpoint estimates derived from available published data where direct comparisons were not possible.

Why is sleep disruption such a pressing issue? 

Sleep disorders affect 50 to 70 million Americans²⁷—more than diabetes, asthma, or depression. The health consequences extend far beyond fatigue: disrupted sleep significantly increases risk of cardiovascular disease²⁸, type 2 diabetes²⁹, and early mortality while impairing memory, weakening immunity, and accelerating cognitive decline³⁰.

The result: millions cycling through interventions that either don't work or risk long-term health concerns. Sleep deprivation costs the U.S. economy over $400 billion annually³⁰, but the true cost is measured in diminished quality of life and suffering that compounds over time.

What does this analysis add to the field?

This real-world analysis joins the growing body of Mindbloom-led research—including Hull et al., 2022, Journal of Affective Disorders and Mathai et al., 2024, Journal of Affective Disorders—the two largest peer-reviewed studies of ketamine therapy published to date. With findings now spanning depression, anxiety, PTSD, and sleep, our results reflect not just what we believe is possible, but what our patients are actually experiencing. In a landscape where claims often outpace evidence, we've chosen a different path: publish the data and let the results speak. 

Healing should not require sacrificing time, comfort, or financial stability. Mindbloom's at-home model makes evidence-based treatment accessible at a fraction of the cost of clinic-based alternatives—bringing the possibility of relief to the millions for whom sleep dysfunction has gone unaddressed for too long.

Read and download the full analysis, methodology, and statistical details here.

Want to learn more about at-home ketamine therapy?

• To learn more about Mindbloom's at-home ketamine therapy, visit our homepage.
• If you're ready to explore at-home ketamine therapy, take our brief candidate assessment.
• Read additional research on how ketamine therapy may help with depression, anxiety, and PTSD.
• For safety information about ketamine, click here.
• Questions about Mindbloom? Reach out to our client relations team at support@mindbloom.com.

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