Is the risk of addiction minimal with medications like Belsomra (suvorexant) and Dayvigo (lemborexant)?

From the Guidelines

The risk of addiction with medications like Belsomra (suvorexant) is considered minimal, as there was no evidence of daytime residual or withdrawal symptoms in clinical trials. The American Academy of Sleep Medicine clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults found that the overall frequency of adverse events with suvorexant was not significantly increased versus placebo 1. Additionally, the guideline noted that there was no evidence of daytime residual or withdrawal symptoms, suggesting a low risk of addiction. However, it is essential to note that suvorexant is still a Schedule IV controlled substance, indicating some potential for abuse and dependence.

Some key points to consider when prescribing suvorexant include:

• The medication should be prescribed at the lowest effective dose, typically 10-20mg, to minimize the risk of adverse events and potential dependence.
• Patients should be monitored closely for signs of misuse, particularly those with a history of substance abuse.
• Healthcare providers should discuss the potential for dependence with patients before initiating treatment and implement regular follow-ups to assess continued need.
• The overall benefits of suvorexant, including its effectiveness in improving sleep maintenance insomnia, outweigh the potential harms, according to the American Academy of Sleep Medicine guideline 1.

In terms of Dayvigo (lemborexant), while there is limited information available in the provided evidence, it is also a Schedule IV controlled substance, indicating some potential for abuse and dependence. Healthcare providers should exercise caution when prescribing these medications and closely monitor patients for signs of misuse.

From the FDA Drug Label

9.2 Abuse Abuse of BELSOMRA poses an increased risk of somnolence, daytime sleepiness, impaired reaction time and impaired driving skills In an abuse liability study conducted in recreational polydrug users (n=36), suvorexant (40,80 and 150 mg) produced similar effects as zolpidem (15,30 mg) on subjective ratings of "drug liking" and other measures of subjective drug effects 9.3 Dependence Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. In completed clinical trials with BELSOMRA, there was no evidence for physical dependence with the prolonged use of BELSOMRA

The risk of addiction with medications like Belsomra (suvorexant) is not explicitly stated as minimal. Key points to consider:

• Belsomra contains suvorexant, a Schedule IV controlled substance.
• Abuse liability studies show similar effects to zolpidem, a known drug with abuse potential.
• Physical dependence was not observed in clinical trials, but this does not necessarily mean the risk of addiction is minimal.
• Patients with a history of abuse or addiction to alcohol or other drugs may be at increased risk for abuse and addiction to Belsomra 2 2.

From the Research

Risk of Addiction with Belsomra (Suvorexant) and Dayvigo (Lemborexant)

• The risk of addiction with medications like Belsomra (suvorexant) and Dayvigo (lemborexant) is a concern, but studies suggest that it may be minimal compared to other insomnia medications 3, 4, 5, 6.
• Suvorexant, a dual orexin receptor antagonist, has been shown to have abuse potential, but it is classified as a schedule IV drug, which indicates a lower potential for abuse compared to schedule III drugs like zolpidem 5.
• A study comparing the abuse potential of suvorexant and zolpidem found that suvorexant had similar effects on abuse potential measures, but with a reduced incidence of abuse-related adverse events 5.
• Lemborexant, another dual orexin receptor antagonist, has also been shown to be effective and safe for the treatment of insomnia, with a low risk of addiction 7, 6.
• A systematic review and meta-analysis of randomized, double-blind, placebo-controlled trials of suvorexant and lemborexant found that both medications were efficacious and safe for the treatment of insomnia, with a low risk of adverse events, including hallucinations, suicidal ideation/behavior, and motor vehicle accidents 6.

Comparison of Suvorexant and Lemborexant

• A network meta-analysis found that 5- and 10-mg lemborexant were superior to 20-mg suvorexant in improving sleep onset latency, and that 5-mg lemborexant and suvorexant were similarly well tolerated 3.
• A systematic review and meta-analysis found that both suvorexant and lemborexant were effective and safe for the treatment of insomnia, but that lemborexant may have a faster onset of action and a shorter time to reach maximum concentration 3, 7, 6.

Safety Profile

• The safety profile of suvorexant and lemborexant is generally favorable, with a low risk of adverse events, including somnolence, excessive daytime sleepiness/sedation, fatigue, back pain, dry mouth, and abnormal dreams 4, 7, 6.
• However, somnolence and excessive daytime sleepiness/sedation were more common with lemborexant, particularly at higher doses 7, 6.