From the Guidelines
Suvorexant (Belsomra) is used for the treatment of insomnia disorder, specifically for improving sleep onset latency, total sleep time, and wake after sleep onset in adults.
Key Points
- The FDA labeling information for suvorexant warns of cognitive and behavioral changes, such as amnesia, anxiety, hallucinations, and other neuropsychiatric symptoms 1.
- Moderate-strength evidence from 3-month trials of 15 and 20 mg of suvorexant showed that compared with placebo, suvorexant improved response to therapy, defined as 6-point or greater improvement from baseline in ISI score 1.
- Suvorexant, 15 to 20 mg, reduced sleep onset latency by 6 minutes compared with placebo, and improved total sleep time by 16 minutes and wake after sleep onset by 5 minutes 1.
- The overall evidence for suvorexant was weakly in favor of its effectiveness for the treatment of sleep maintenance insomnia only, with objective reports of wake after sleep onset showing clinically significant reduction at both 10 mg and 20 mg dosages 1.
- Adverse events were assessed in both studies, and the overall frequency of adverse events was not significantly increased versus placebo, with no evidence of daytime residual or withdrawal symptoms 1.
- Moderate-quality evidence showed that suvorexant increased treatment response and improved sleep onset latency, total sleep time, and wake after sleep onset compared with placebo in mixed general and adult populations 1.
From the FDA Drug Label
BELSOMRA® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. BELSOMRA is an orexin receptor antagonist indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance (1). BELSOMRA® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
Suvorexant (Belsomra) is used for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance 2, 2, 2.
From the Research
Suvorexant (Belsomra) Usage
- Suvorexant, also known as Belsomra, is a dual orexin receptor antagonist used for the treatment of insomnia 3, 4, 5, 6.
- Insomnia is a condition characterized by poor quality and/or quantity of sleep, and suvorexant works by targeting the orexin receptors to improve sleep onset and maintenance 3, 4.
- Suvorexant has been shown to be effective in improving sleep time, onset, latency, and quality compared to placebo in clinical trials 3, 4, 5.
Target Population
- Suvorexant is approved for use in adults with insomnia, including nonelderly and elderly patients 5, 6.
- The drug has been studied in patients with primary insomnia, as well as those with secondary insomnia and comorbidities such as obstructive sleep apnea, Alzheimer's disease, dementia, acute stroke, and delirium 3, 4.
Dosage and Administration
- Suvorexant is available in different doses, including 10-20 mg for elderly patients and 40/30 mg for nonelderly patients 5, 6.
- The drug is administered orally, and its pharmacokinetics may be affected by CYP3A modulators 7.
Safety and Efficacy
- Suvorexant has been shown to be generally safe and well-tolerated in clinical trials, with common adverse effects including dizziness, somnolence, headaches, and cognitive impairment 3, 4, 5, 6.
- The drug has a better safety profile compared to existing therapies, and it preserves natural sleep architecture, promoting more restful sleep and recovery 4.