Belsomra in US 2025
Belsomra (suvorexant) represents a significant advancement in insomnia treatment within the United States healthcare system. As the first orexin receptor antagonist approved by the FDA, this medication has carved out a unique position in the sleep aid market since its initial approval on August 13, 2014. The drug works through a novel mechanism by blocking orexin, a neurotransmitter that promotes wakefulness, thereby helping patients fall asleep and stay asleep throughout the night. As a Schedule IV controlled substance under the Drug Enforcement Administration classification, Belsomra is recognized as having accepted medical use with a low potential for abuse relative to higher schedule drugs.
The prevalence of insomnia in the United States has created substantial demand for effective sleep medications. According to the Centers for Disease Control and Prevention, approximately 50 to 70 million Americans suffer from sleep disorders, with insomnia being the most common. The CDC reports that 35% of United States adults experience insufficient sleep duration, getting less than the recommended 7 hours per night. Furthermore, 14.5% of US adults reported trouble falling asleep most days or every day, while 17.8% of adults experienced difficulty staying asleep. These statistics underscore the critical public health challenge that medications like Belsomra aim to address in the contemporary American healthcare landscape.
Interesting Facts About Belsomra in the US 2025
| Key Fact Category | Verified Statistic | Source |
|---|---|---|
| FDA Approval Date | August 13, 2014 | FDA |
| Drug Classification | Schedule IV Controlled Substance | DEA |
| Mechanism of Action | First-in-class orexin receptor antagonist | FDA |
| Available Dosage Strengths | 5 mg, 10 mg, 15 mg, 20 mg tablets | FDA |
| Recommended Starting Dose | 10 mg once nightly | FDA |
| Maximum Recommended Dose | 20 mg once daily | FDA |
| Clinical Trial Participants | 1,784 patients in safety/efficacy studies | FDA |
| Elderly Patients in Trials | 829 patients aged 65+ years | FDA |
| Peak Concentration Time | 2 hours (median) under fasted conditions | FDA |
| Drug Half-Life | Approximately 12 hours | FDA |
| Bioavailability | 82% for 10 mg dose | FDA |
| Primary Elimination Route | 66% feces, 23% urine | FDA |
| Steady-State Achievement | 3 days of once-daily dosing | FDA |
| Contraindication | Patients with narcolepsy | FDA |
| Most Common Adverse Reaction | Somnolence (7% vs 3% placebo) | FDA |
Data source: U.S. Food and Drug Administration (FDA) Prescribing Information for Belsomra, 2014
The FDA-approved prescribing information reveals critical statistics about Belsomra’s development and clinical profile. The medication underwent rigorous testing involving 1,784 patients across controlled clinical safety and efficacy studies, with a significant proportion being elderly patients (829 patients aged 65 years and over, including 159 patients aged 75 years and over). The drug is available in four distinct dosage strengths to accommodate different patient needs and tolerance levels. The recommended starting dose of 10 mg once nightly can be increased to a maximum of 20 mg once daily if the lower dose proves well-tolerated but ineffective. The medication demonstrates reliable pharmacokinetic properties, achieving peak blood concentrations within 2 hours and maintaining a half-life of approximately 12 hours, which allows for once-daily nighttime dosing without significant next-day residual effects for most patients at recommended doses.
Insomnia Prevalence in the US 2025
| Population Category | Statistic | Details |
|---|---|---|
| Total Americans with Sleep Disorders | 50-70 million | Chronic sleep disorders or deprivation |
| Adults with Insufficient Sleep | 35% | Less than 7 hours per night |
| Adults with Trouble Falling Asleep | 14.5% | Most days or every day in past 30 days |
| Adults with Trouble Staying Asleep | 17.8% | Most days or every day in past 30 days |
| Chronic Insomnia Prevalence | 10-15% | Persistent insomnia over multiple months |
| Occasional Insomnia Symptoms | 20% | Experience occasional sleep difficulties |
| Women vs Men (Falling Asleep) | 17.1% vs 11.7% | Women more affected |
| Women vs Men (Staying Asleep) | 20.7% vs 14.7% | Women more affected |
| Sleep Aid Prescription Use | 4.1% of adults | Used prescription sleep aid in past month |
| Adults Using Sleep Medication | 18% | Any type of sleep medication |
Data source: Centers for Disease Control and Prevention (CDC) National Health Interview Survey, National Health and Nutrition Examination Survey, 2020-2022
The Centers for Disease Control and Prevention data paint a comprehensive picture of the insomnia crisis affecting American adults. Between 50 and 70 million Americans struggle with chronic sleep disorders, representing a substantial public health burden. The CDC’s National Health Interview Survey from 2020 documented that 14.5% of adults reported trouble falling asleep most days or every day during the previous month, with women experiencing significantly higher rates (17.1%) compared to men (11.7%). Even more concerning, 17.8% of adults reported difficulty staying asleep, with women again disproportionately affected at 20.7% versus 14.7% for men. The prevalence of chronic insomnia, defined as persistent sleep difficulties over multiple months, affects approximately 10-15% of the adult population, while an additional 20% experience occasional insomnia symptoms. These statistics establish the context for why medications like Belsomra have become increasingly important therapeutic options, with 4.1% of adults reporting prescription sleep aid use in the past month according to CDC estimates.
Clinical Efficacy Data for Belsomra in the US 2025
| Efficacy Measure | Baseline (minutes) | Change with Belsomra | Change with Placebo | Benefit vs Placebo |
|---|---|---|---|---|
| Time to Fall Asleep (Month 1) | 66-69 | -33 to -34 minutes | -23 to -25 minutes | -8 to -10 minutes |
| Time to Fall Asleep (Month 3) | 66-69 | -29 to -35 minutes | -27 to -29 minutes | 0 to -8 minutes |
| Wake After Sleep Onset (Month 1) | 115-120 | -45 to -47 minutes | -19 to -23 minutes | -24 to -26 minutes |
| Wake After Sleep Onset (Month 3) | 115-120 | -42 to -56 minutes | -25 minutes | -17 to -31 minutes |
| Patient-Estimated Sleep Onset (Month 1) | 64-86 | -17 to -21 minutes | -12 to -14 minutes | -5 to -7 minutes |
| Patient-Estimated Sleep Onset (Month 3) | 64-86 | -23 to -28 minutes | -17 to -21 minutes | -5 to -8 minutes |
| Patient-Estimated Total Sleep Time (Month 1) | 299-322 | +39 to +43 minutes | +22 to +23 minutes | +16 to +21 minutes |
| Patient-Estimated Total Sleep Time (Month 3) | 299-322 | +51 to +60 minutes | +38 to +41 minutes | +11 to +22 minutes |
Data source: FDA Clinical Studies Section, Belsomra Prescribing Information, Studies 1 and 2, 2014
The FDA-documented clinical trial results demonstrate Belsomra’s efficacy across multiple sleep parameters measured through objective polysomnography and subjective patient reports. In two pivotal 3-month randomized controlled trials involving both elderly and non-elderly patients, Belsomra showed statistically significant improvements in sleep onset latency. At month 1, patients taking Belsomra 15-20 mg fell asleep 8 to 10 minutes faster compared to placebo based on objective measurements. The most impressive results appeared in sleep maintenance, where Belsomra reduced wake time after sleep onset by 24 to 26 minutes more than placebo at month 1, with sustained effects of 17 to 31 minutes improvement at month 3. Patient-estimated total sleep time increased by an additional 16 to 21 minutes compared to placebo at month 1, expanding to 11 to 22 minutes at month 3. These clinical trial statistics establish that Belsomra provides meaningful therapeutic benefits beyond placebo effects, with 493 patients receiving the recommended 15-20 mg doses across the pivotal studies. The medication demonstrated efficacy starting from night 1 and week 1 of treatment, with effects generally consistent across time points.
Patient Demographics in Belsomra Clinical Trials in the US 2025
| Demographic Category | Number of Patients | Percentage/Details |
|---|---|---|
| Total Patients in Safety Studies | 1,784 | All controlled clinical studies |
| Patients Receiving 15-20 mg | 493 | Recommended dose range |
| Male Patients (15-20 mg dose) | 174 | 35% of 15-20 mg group |
| Female Patients (15-20 mg dose) | 319 | 65% of 15-20 mg group |
| Elderly Patients (≥65 years) | 829 | 46% of total patients |
| Very Elderly Patients (≥75 years) | 159 | 9% of total patients |
| Non-Elderly Adults (18-64 years) | 955 | 54% of total patients |
| Mean Age (15 mg elderly group) | 70 years | Elderly patient group |
| Mean Age (20 mg non-elderly group) | 45 years | Non-elderly patient group |
| Patients Treated ≥3 Months | 290 | Long-term exposure at 15-20 mg |
| Non-Caucasian Patients | 27% | Diverse racial representation |
| Asian Patients (of non-Caucasians) | 69% | Within non-Caucasian group |
Data source: FDA Clinical Trials Experience Section, Belsomra Prescribing Information, 2014
The FDA clinical trial data reveals a well-designed study population that reflects the diversity of insomnia patients in the United States. Out of 1,784 total patients enrolled in controlled clinical safety and efficacy studies, 493 patients received the currently recommended doses of 15 mg (elderly) or 20 mg (non-elderly). The gender distribution showed 65% female and 35% male participants at these doses, which aligns with the known higher prevalence of insomnia in women. A substantial proportion were elderly patients, with 829 patients aged 65 years and over and 159 patients aged 75 years and over, demonstrating the medication’s safety profile in this vulnerable population. The mean age in the elderly group receiving 15 mg was 70 years, while non-elderly adults receiving 20 mg had a mean age of 45 years. Importantly, 27% of patients in the pivotal Studies 1 and 2 were non-Caucasian, with 69% of this non-Caucasian group being Asian, providing valuable data on Belsomra’s efficacy across different racial and ethnic backgrounds. The long-term safety data included 290 patients who continued treatment for 3 months or longer at recommended doses.
Safety Profile and Adverse Reactions of Belsomra in the US 2025
| Safety Parameter | Belsomra 15-20 mg | Placebo | Statistical Significance |
|---|---|---|---|
| Discontinuation Due to Adverse Reactions | 3% | 5% | Lower than placebo |
| Somnolence (Overall) | 7% | 3% | Most common reaction |
| Somnolence in Females | 8% | Not specified | Higher in women |
| Somnolence in Males | 3% | Not specified | Lower in men |
| Headache | 7% | 6% | Minimal difference |
| Dizziness | 3% | 2% | Slight increase |
| Diarrhea | 2% | 1% | Minimal increase |
| Dry Mouth | 2% | 1% | Minimal increase |
| Abnormal Dreams | 2% | 1% | Minimal increase |
| Upper Respiratory Tract Infection | 2% | 1% | Minimal increase |
| Cough | 2% | 1% | Minimal increase |
| Dose-Related Somnolence (10 mg) | 2% | <1% | Dose-dependent effect |
| Dose-Related Somnolence (20 mg) | 5% | <1% | Dose-dependent effect |
| Dose-Related Somnolence (40 mg) | 12% | <1% | Higher at supratherapeutic doses |
Data source: FDA Adverse Reactions Section, Belsomra Prescribing Information, Clinical Trials Data, 2014
The FDA safety database demonstrates that Belsomra has a generally favorable tolerability profile at recommended doses. The discontinuation rate due to adverse reactions was actually lower with Belsomra 15-20 mg at 3% compared to 5% for placebo, indicating good overall tolerability. Somnolence, or drowsiness the next day, was the most common adverse reaction, occurring in 7% of patients taking Belsomra versus 3% on placebo during the first three months of treatment. This adverse effect showed clear gender differences, affecting 8% of females but only 3% of males at the 15-20 mg dose. Other adverse reactions occurring in at least 2% of patients and greater than placebo included headache (7% vs 6%), dizziness (3% vs 2%), and several minor effects at 2% frequency. The medication demonstrated a dose-dependent relationship for somnolence, with rates of 2% at 10 mg, 5% at 20 mg, and 12% at 40 mg (twice the maximum recommended dose) in crossover studies. No individual adverse reaction led to discontinuation at a rate of 1% or higher, further supporting the medication’s acceptable safety profile for most patients.
Pharmacokinetic Properties of Belsomra in the US 2025
| Pharmacokinetic Parameter | Value | Clinical Significance |
|---|---|---|
| Bioavailability (10 mg dose) | 82% | High absorption rate |
| Peak Concentration Time (Tmax) | 2 hours (median) | Range: 30 minutes to 6 hours |
| Elimination Half-Life (t1/2) | 12 hours | 95% CI: 12-13 hours |
| Time to Steady-State | 3 days | With once-daily dosing |
| Accumulation Factor | 1- to 2-fold | With once-daily dosing |
| Protein Binding | >99% | Extensive binding |
| Volume of Distribution | 49 liters | Moderate distribution |
| Primary Metabolism Pathway | CYP3A | Major elimination route |
| Secondary Metabolism Pathway | CYP2C19 | Minor contribution |
| Fecal Excretion | 66% | Primary elimination |
| Urinary Excretion | 23% | Secondary elimination |
| Food Effect on Absorption | 1.5-hour Tmax delay | No AUC or Cmax change |
| Exposure Increase in Females | AUC +17%, Cmax +9% | Gender difference (40 mg dose) |
| Exposure Increase in Obese | AUC +31%, Cmax +17% | BMI effect |
| Exposure Increase in Obese Females | AUC +46%, Cmax +25% | Combined gender and BMI effect |
Data source: FDA Clinical Pharmacology Section, Belsomra Prescribing Information, Pharmacokinetics Studies, 2014
The FDA pharmacokinetic data for Belsomra reveals predictable and clinically relevant drug behavior. The medication demonstrates high bioavailability at 82% for the 10 mg dose, ensuring reliable drug delivery. Peak blood concentrations occur at a median of 2 hours after administration under fasted conditions, with individual variation ranging from 30 minutes to 6 hours. The elimination half-life of approximately 12 hours supports once-nightly dosing without excessive accumulation, though the drug reaches steady-state concentrations within 3 days with accumulation of 1- to 2-fold. Suvorexant is more than 99% protein-bound in plasma, distributing into a moderate volume of approximately 49 liters. The primary metabolic pathway involves CYP3A enzymes, with a minor contribution from CYP2C19, making drug interactions with CYP3A inhibitors and inducers clinically significant. Elimination occurs primarily through feces (66%) and secondarily through urine (23%). Important pharmacokinetic differences exist based on patient characteristics: females show 17% higher AUC and 9% higher Cmax than males; obese patients demonstrate 31% higher AUC and 17% higher Cmax; and obese females exhibit the greatest exposure increases at 46% higher AUC and 25% higher Cmax compared to non-obese females, considerations important for dose selection.
Drug Interaction Profile of Belsomra in the US 2025
| Interacting Drug/Class | Effect on Belsomra | Recommendation |
|---|---|---|
| Strong CYP3A Inhibitors | Substantially increased exposure | Not recommended |
| Ketoconazole | Substantial increase | Not recommended |
| Itraconazole | Substantial increase | Not recommended |
| Clarithromycin | Substantial increase | Not recommended |
| Moderate CYP3A Inhibitors | Moderately increased exposure | Reduce dose to 5 mg |
| Diltiazem | Moderate increase | Maximum 10 mg if needed |
| Erythromycin | Moderate increase | Maximum 10 mg if needed |
| Strong CYP3A Inducers | Substantially decreased exposure | Efficacy may be reduced |
| Rifampin | Substantial decrease | May reduce effectiveness |
| Carbamazepine | Substantial decrease | May reduce effectiveness |
| Alcohol | Additive psychomotor impairment | Avoid combination |
| CNS Depressants | Increased CNS depression risk | Dosage adjustment may be needed |
| Benzodiazepines | Additive effects | Use caution |
| Opioids | Additive effects | Use caution |
| Digoxin | Slightly increased digoxin levels | Monitor digoxin concentrations |
Data source: FDA Drug Interactions Section, Belsomra Prescribing Information, 2014
The FDA-documented drug interaction profile for Belsomra highlights critical considerations for safe prescribing. Because CYP3A enzymes represent the major elimination pathway for suvorexant, drugs affecting this enzyme system have clinically significant effects. Strong CYP3A inhibitors such as ketoconazole, itraconazole, and clarithromycin substantially increase Belsomra exposure and are not recommended for concurrent use. Moderate CYP3A inhibitors including diltiazem and erythromycin also increase exposure, necessitating dose reduction to 5 mg with a maximum of 10 mg if the lower dose proves insufficient. Conversely, strong CYP3A inducers like rifampin and carbamazepine substantially decrease suvorexant exposure, potentially reducing the medication’s efficacy. The interaction with alcohol is particularly important: co-administration produces additive psychomotor impairment without altering Belsomra’s pharmacokinetics, making alcohol use with Belsomra contraindicated. Other CNS depressants including benzodiazepines, opioids, and tricyclic antidepressants increase the risk of excessive CNS depression, requiring careful dosage adjustment of both medications when used together. Additionally, Belsomra slightly increases digoxin levels through intestinal P-glycoprotein inhibition, necessitating digoxin concentration monitoring when these drugs are co-administered.
Special Population Considerations for Belsomra in the US 2025
| Population | FDA Findings | Dosing Recommendation |
|---|---|---|
| Elderly (≥65 years) | No clinically meaningful differences | Standard dosing, start with 15 mg |
| Very Elderly (≥75 years) | Similar safety/efficacy profile | Standard elderly dosing |
| Females | 17% higher AUC, 9% higher Cmax (40 mg) | Generally no adjustment needed |
| Obese Patients (BMI >30) | 31% higher AUC, 17% higher Cmax | Consider exposure before dose increase |
| Obese Females | 46% higher AUC, 25% higher Cmax | Careful consideration before increasing dose |
| Mild Hepatic Impairment | No dose adjustment needed | Standard dosing |
| Moderate Hepatic Impairment | Similar exposure, longer half-life (19 vs 15 hours) | No dose adjustment needed |
| Severe Hepatic Impairment | Not studied | Not recommended |
| Renal Impairment (any severity) | No significant exposure changes | No dose adjustment needed |
| Severe Renal Impairment | Similar total and unbound concentrations | No dose adjustment needed |
| Pregnancy Category | Category C | Use only if benefit justifies risk |
| Nursing Mothers | Present in rat milk (9x plasma levels) | Exercise caution |
| Pediatric Patients | Not established | Not recommended for children <18 |
| Mild-Moderate OSA | Some respiratory concerns | Consider carefully |
| Severe OSA | Not studied | Not recommended |
Data source: FDA Use in Specific Populations Section, Belsomra Prescribing Information, 2014
The FDA has established comprehensive guidelines for Belsomra use across different patient populations based on dedicated pharmacokinetic and safety studies. In elderly patients, 829 individuals aged 65 and over and 159 aged 75 and over participated in clinical trials, revealing no clinically meaningful differences in safety or effectiveness compared to younger patients at recommended doses, though higher fall risk due to drowsiness remains a concern. Gender-based differences show females have 17% higher AUC and 9% higher Cmax, but dose adjustment based on gender alone is generally not required. Obesity significantly affects drug exposure, with obese patients showing 31% higher AUC and 17% higher Cmax, and obese females demonstrating even greater increases of 46% AUC and 25% Cmax elevation, warranting careful consideration before dose escalation. Hepatic impairment studies showed no dose adjustment needed for mild or moderate liver disease, though moderate impairment extends the half-life from 15 to 19 hours; however, the drug has not been studied in severe hepatic impairment and is not recommended for these patients. Renal function has minimal impact, with severe renal impairment producing similar drug concentrations, requiring no dose adjustment. The medication is Pregnancy Category C, meaning it should be used only if potential benefits justify fetal risks. For nursing mothers, animal studies showed drug presence in milk at 9 times plasma levels, requiring caution. Pediatric use remains not established in children under 18 years.
Dosing Guidelines and Administration for Belsomra in the US 2025
| Patient Population | Starting Dose | Maximum Dose | Key Administration Guidelines |
|---|---|---|---|
| Non-Elderly Adults (18–64 years) | 10 mg | 20 mg once daily | Take within 30 minutes of bedtime |
| Elderly Adults (≥65 years) | 10 mg (may start at 5 mg) | 20 mg once daily | Higher sensitivity possible |
| With Moderate CYP3A Inhibitors | 5 mg | 10 mg once daily | Reduced dose required |
| With Strong CYP3A Inhibitors | Not recommended | Not recommended | Avoid combination |
| Obese Patients | 10 mg | Assess exposure before increasing | Individual assessment needed |
| Obese Females | 10 mg | Increase with caution | Highest exposure risk |
| Time Before Bed | Within 30 minutes | N/A | Critical timing requirement |
| Minimum Sleep Time Needed | At least 7 hours | N/A | Full night required |
| With High-Fat Meal | Not optimal | N/A | Delays effect by ~1.5 hours |
| Frequency | Once per night | N/A | Never exceed once nightly |
| With Alcohol | Contraindicated | N/A | Do not combine |
| With Other CNS Depressants | Dose adjustment required | N/A | Careful monitoring advised |
Data source: FDA Dosage and Administration Section, Belsomra Prescribing Information, 2014
The FDA has established specific dosing guidelines to optimize Belsomra’s efficacy and safety profile. The recommended starting dose for most patients is 10 mg, taken no more than once per night and within 30 minutes of going to bed, with at least 7 hours remaining before the planned time of awakening. If the 10 mg dose is well-tolerated but not effective, it can be increased to a maximum of 20 mg once daily. These instructions apply to both non-elderly adults (ages 18-64) and elderly patients (ages 65 and over), though elderly patients may experience higher sensitivity. For patients taking moderate CYP3A inhibitors such as diltiazem or erythromycin, the recommended dose is reduced to 5 mg and generally should not exceed 10 mg. Use with strong CYP3A inhibitors is not recommended due to excessive drug exposure. Obese patients, particularly obese females who experience 46% higher AUC and 25% higher Cmax, require careful consideration before dose increases. The timing of administration is critical: taking Belsomra with or soon after a high-fat meal delays the time to peak effect by approximately 1.5 hours, potentially reducing sleep onset benefits. Alcohol consumption is contraindicated when taking Belsomra due to additive psychomotor impairment. When combined with other CNS depressants, dosage adjustment of Belsomra and/or the concomitant drug may be necessary due to potentially additive effects.
Sleep Medication Usage Patterns in the US 2025
| Usage Category | Percentage/Number | Population Details |
|---|---|---|
| Adults Using Prescription Sleep Aids | 4.1% | Past 30 days (2005-2010) |
| Adults Using Any Sleep Medication | 18% | Includes prescription and OTC (2020) |
| Regular Sleep Medication Users | 8% | Most nights or every night (2020) |
| Occasional Sleep Medication Users | 10% | Some nights (2020) |
| Prescription Sleep Aid Use (2022) | 8% | Prescription medication only |
| Non-Medicinal Sleep Aid Use (2022) | 11% | Tea, melatonin, supplements |
| Elderly Using Prescription Sleep Aids (65+) | 8% | Regular or occasional use |
| Elderly with Frequent Sleep Issues Using Rx | 23% | Among those with 3+ nights/week problems |
| Patients with Sleep Disorder Diagnosis Using Aids | >16% | Past 30 days |
| Patients Reporting Sleep Trouble to Doctor Using Aids | ~13% | Past 30 days |
| Sleep Aid Use Increase (Ages 80+) | 7% | Highest age-related usage |
| Women Using Sleep Aids | 5% | Prescription medication past month |
| Men Using Sleep Aids | 3.1% | Prescription medication past month |
Data source: CDC National Health and Nutrition Examination Survey, National Health Interview Survey, Multiple Years
The CDC data reveals evolving patterns in sleep medication usage across the United States population. Between 2005-2010, 4.1% of adults reported using prescription sleep aids in the past month, a figure that has increased substantially in recent years. By 2020, 18% of U.S. adults were using some type of medication to help them sleep, whether prescription or over-the-counter, representing a significant portion of the population seeking pharmaceutical solutions for sleep problems. This breaks down into 8% using medication most nights or every night, and 10% using it some nights. More recent 2022 data shows 8% of adults specifically using prescription sleep medication, while 11% use non-medicinal sleep aids like melatonin or herbal teas. The usage patterns show clear demographic variations: women use prescription sleep aids at higher rates (5%) compared to men (3.1%), and usage increases with age, reaching 7% among adults aged 80 and older. Among elderly adults (65+), 8% use prescription sleep medications either regularly or occasionally. Notably, among elderly patients with frequent sleep issues (three or more nights per week), prescription sleep aid usage jumps to 23%, indicating that those with more severe insomnia are more likely to seek pharmacological intervention. Patients with a physician diagnosis of a sleep disorder show usage rates exceeding 16%, approximately five times higher than those without such a diagnosis.
Disclaimer: The data research report we present here is based on information found from various sources. We are not liable for any financial loss, errors, or damages of any kind that may result from the use of the information herein. We acknowledge that though we try to report accurately, we cannot verify the absolute facts of everything that has been represented.
