What are the problems with Belsomra?

October 12, 2025 •

4 min read

According to a 2016 analysis of FDA safety reports, more than 1,000 complaints were filed regarding the sleeping pill suvorexant, better known as Belsomra, citing a range of issues from ineffectiveness to serious side effects like agitation and disturbed sleep. This highlights some of the significant problems with Belsomra that patients and healthcare providers must consider.

Quick Summary

Belsomra, an orexin receptor antagonist, carries risks including next-day drowsiness, complex sleep behaviors like sleep-driving, and psychiatric effects such as worsening depression. Efficacy can be modest compared to placebo, and the drug has notable interactions with alcohol and other medications.

Key Points

Next-day impairment: Belsomra commonly causes daytime drowsiness, reduced alertness, and impaired coordination, which can persist for days and increase the risk of accidents and falls.
Complex sleep behaviors: The drug can induce parasomnias like sleep-walking or sleep-driving, often with no memory of the event, which are dangerous and require immediate discontinuation.
Significant drug interactions: Metabolized by CYP3A enzymes, Belsomra has serious interactions with many drugs, including antifungals and certain antibiotics, and its effects are intensified by alcohol.
Limited effectiveness: For many users, Belsomra offers only modest improvements in sleep onset and duration, with some reporting it doesn't work at all.
Psychiatric risks: It can worsen depression and has been linked to suicidal ideation, agitation, and anxiety, particularly in patients with a history of such issues.
Controlled substance classification: As a Schedule IV controlled substance, Belsomra has a potential for misuse and dependence, and its prescription is subject to regulations.

Belsomra (suvorexant) is a medication for insomnia that works by targeting the orexin system, which helps regulate wakefulness. This differs from older sleep medications that primarily induce sedation. Despite its unique mechanism, several problems with Belsomra have emerged since its introduction, necessitating careful consideration of its use.

Next-Day Impairment

A common issue with Belsomra is its lingering effect, which can lead to impairment the following day.

Daytime Drowsiness and Reduced Alertness

The most frequently reported side effect of Belsomra is daytime sleepiness. This can result in decreased alertness and coordination. The risk of drowsiness increases with higher doses and may persist for several days after discontinuing the drug. This residual effect can be hazardous for activities requiring concentration, like driving or operating machinery. The FDA advises against driving for at least 8 hours after taking Belsomra.

Increased Fall Risk

Older adults taking Belsomra may face an increased risk of falls due to drowsiness and impaired coordination. Lower doses are often recommended for this population, along with close monitoring.

Complex Sleep Behaviors and Psychiatric Effects

Belsomra can cause more serious behavioral and psychological issues.

Unconscious Actions During Sleep

Complex sleep behaviors, known as parasomnias, have been linked to Belsomra and other sleep aids. These activities occur while a person is not fully awake and may include sleep-walking, sleep-driving, eating, making phone calls, or engaging in sexual activity. Patients typically do not remember these events, which can be dangerous. If complex sleep behaviors occur, Belsomra should be stopped immediately.

Mood and Mental Health Changes

Belsomra can exacerbate symptoms in individuals with pre-existing psychiatric conditions, such as depression, and may lead to suicidal thoughts or behaviors. Other reported effects include agitation, anxiety, abnormal thinking, and hallucinations. The likelihood of these effects increases with higher doses.

Sleep Paralysis and Hallucinations

Sleep paralysis (inability to move or speak during sleep transitions) and hallucinations have also been reported by some Belsomra users.

Effectiveness Concerns and Cost

Despite its novel approach, Belsomra's clinical benefits can be limited for many patients, which is a drawback given its potential side effects and price. Studies show that Belsomra offers only small improvements over a placebo in helping people fall and stay asleep. Some users report minimal or no subjective improvement. This limited effectiveness, coupled with potential side effects and a higher cost compared to older alternatives, makes it less suitable for some individuals. Non-drug treatments like Cognitive Behavioral Therapy for Insomnia (CBT-I) are often recommended first due to their proven effectiveness with fewer risks.

Drug Interactions and Important Warnings

Belsomra can interact with various medications and is not appropriate for everyone.

Interactions with Other Drugs

Belsomra is processed by the liver enzyme CYP3A. Drugs that affect this enzyme can impact Belsomra levels:

Strong CYP3A inhibitors (like certain antifungals or antibiotics) can increase Belsomra levels and the risk of side effects. Using Belsomra with strong inhibitors is generally not advised.
Strong CYP3A inducers (like some anti-seizure drugs) can lower Belsomra levels, potentially making it less effective.
Combining Belsomra with other CNS depressants, including alcohol, opioids, and benzodiazepines, increases the risk of sedation and impairment. Alcohol should be avoided while taking Belsomra.

Contraindications and Precautions

Belsomra should not be used by individuals with narcolepsy. Caution and dose adjustments may be needed for those with liver problems, respiratory issues (like severe COPD or sleep apnea), or a history of substance abuse.


Feature	Belsomra (Suvorexant)	Zolpidem (Ambien)
Drug Class	Dual Orexin Receptor Antagonist	Non-benzodiazepine Hypnotic (Z-drug)
Mechanism	Blocks wake-promoting orexin signaling	Increases GABA effects, inducing sedation
Common Side Effect	Next-day drowsiness, headache	Next-day drowsiness, dizziness
Complex Sleep Behaviors	Yes, documented	Yes, well-documented
Abuse Potential	Schedule IV controlled substance	Schedule IV controlled substance
Efficacy Profile	Modest improvements vs. placebo	Modest improvements vs. placebo, quicker onset
Drug Interactions	CYP3A4 inhibitors/inducers, CNS depressants	CYP3A4 inhibitors, CNS depressants

Conclusion

While Belsomra offers a different approach to treating insomnia, it comes with notable problems and limitations. Key concerns include the risk of next-day impairment and serious complex sleep behaviors. The relatively modest effectiveness for many users is a significant factor, especially when considering the potential side effects and cost. Careful patient selection is important due to drug interactions and contraindications, particularly for those with psychiatric or respiratory conditions. Given these factors, Belsomra should be considered carefully, ideally after exploring non-drug options, with a clear understanding of its risks and benefits. {Link: Belsomra Medication Guide https://www.merck.com/product/usa/pi_circulars/b/belsomra/belsomra_mg.pdf}.

For more information on insomnia treatments, the Mayo Clinic offers resources on alternatives to medication.

Frequently Asked Questions

The most common side effects of Belsomra include daytime drowsiness, headache, dizziness, and abnormal dreams. Other potential effects include dry mouth, diarrhea, and upper respiratory tract infections.

Yes, Belsomra has been reported to cause complex sleep behaviors, such as sleep-walking, sleep-driving, or preparing food while not fully awake. Patients often have no memory of these events and should stop taking the medication if they occur.

Yes, Belsomra has a dangerous interaction with alcohol and other central nervous system (CNS) depressants. The combination can cause excessive sedation, impaired coordination, and slowed reaction time.

No, clinical trials and patient reports indicate that Belsomra offers only modest benefits for many individuals, sometimes providing minimal improvement over a placebo. Some users report that it is ineffective for their sleep problems.

Belsomra carries a warning for worsening depression and suicidal ideation, especially at higher doses. Patients with a history of depression should be monitored carefully.

Next-day drowsiness is common and can last for several days after stopping the medication. The risk is higher with larger doses or if less than a full night's sleep is obtained.

Belsomra is contraindicated in people with narcolepsy. It should be avoided or used with caution in individuals with severe liver impairment, compromised respiratory function (severe COPD or sleep apnea), or a history of substance abuse or depression.