From the Guidelines
Lemborexant is generally safe for extended use in treating insomnia, but potential concerns include tolerance, dependence, and ongoing daytime drowsiness or dizziness. When used as prescribed, typically 5 or 10 mg taken once per night, lemborexant can be effective for several months to a year or more without significant loss of efficacy. Long-term use may lead to tolerance, where higher doses are needed for the same effect, though this appears less common than with some other sleep medications. There's also a potential for dependence, making it difficult to stop the medication. Some users report ongoing daytime drowsiness or dizziness, which could impact daily activities if persistent. Cognitively, there's no strong evidence of negative long-term effects, but as with many sleep medications, there's a theoretical concern about potential impacts on memory or cognitive function with very prolonged use, as noted in studies of similar medications such as suvorexant 1. Regular follow-ups with a healthcare provider are important to monitor for any emerging side effects or changes in effectiveness. It's worth noting that treating chronic insomnia effectively can have significant long-term health benefits, potentially outweighing risks for many patients. However, combining lemborexant with cognitive behavioral therapy for insomnia (CBT-I) may provide the best long-term outcomes, potentially allowing for eventual discontinuation of the medication, as suggested by guidelines for the pharmacologic treatment of insomnia disorder 1. Key considerations for the use of lemborexant and other sleep medications include the potential for adverse effects such as cognitive and behavioral changes, complex behaviors, and worsening of depression, as warned by the FDA labeling information for orexin receptor antagonists like suvorexant 1. Given the available evidence, the most appropriate approach is to use lemborexant judiciously, at the lowest effective dose, and to regularly assess its effectiveness and potential side effects.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Long-term Effects of Lemborexant (Dayvigo)
The long-term effects of lemborexant (Dayvigo) have been studied in several clinical trials. Here are the key findings:
- Lemborexant has been shown to be effective in improving sleep onset and sleep maintenance in adults with insomnia disorder, with significant benefits observed over six months and maintained at twelve months 2.
- The medication has been found to have a favorable safety profile, with most treatment-emergent adverse events (TEAEs) being mild or moderate, and the most common TEAEs being nasopharyngitis, somnolence, and headache 2.
- Lemborexant has been compared to other medications, such as gamma-aminobutyric acid-benzodiazepine (GABA-BZ) receptor agonists and suvorexant, and has been found to have fewer adverse effects and improved efficacy in some cases 3.
- The medication has been found to have a dose-dependent pattern, with slight variations in efficacy and safety between the 5 mg and 10 mg doses 4.
- Lemborexant has been shown to improve sleep quality, reduce sleep onset latency, and increase total sleep time, with effects lasting up to 12 months after therapy 4.
Efficacy and Safety
The efficacy and safety of lemborexant have been evaluated in several studies, including:
- A phase 3 randomized clinical trial that found lemborexant to be effective and safe in adults with insomnia disorder, with significant benefits observed over twelve months 2.
- A systematic review that compared the efficacy and safety of lemborexant 5 mg versus 10 mg, and found that both doses were effective and safe, with slight variations in efficacy and safety between the two doses 4.
- A study that evaluated the safety and efficacy of lemborexant in patients with insomnia who were taking GABA-BZ receptor agonists or suvorexant, and found that lemborexant was a useful alternative with fewer adverse effects 3.
Residual Effects
The residual effects of lemborexant have been evaluated in several studies, including:
- A study that found that lemborexant did not substantially impair next-day functioning in healthy subjects and subjects with insomnia, with no significant differences in postural stability, cognitive performance, or driving performance compared to placebo 5.
- A study that found that lemborexant improved morning alertness and reduced sleepiness, with significant benefits observed over six months and maintained at twelve months 2.