Dayvigo Approved for Treatment of Insomnia

December 23, 2019 – The U.S. FDA has approved DayvigoTM (lemborexant) to treat adult patients who have insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

Insomnia affects approximately 40 million people in the United States each year. The sleep disorder is characterized by difficulty falling asleep and/or staying asleep, which can include waking during the night and the inability to sleep until a planned wake-up time. Insomnia can cause problems during the day such as fatigue, anxiety, irritability, and difficulty with learning, memory, and performing tasks. The condition can result from a variety of factors, including medical and psychiatric conditions, poor sleep hygiene, shift work, certain medications, and environmental factors.

In clinical studies, patients who received Dayvigo experienced statistically significant improvement in three areas compared to placebo. These areas were sleep onset latency (the estimated time from when a patient first tries to sleep until sleep onset), sleep efficiency (the proportion of time spent asleep while in bed), and wake after sleep onset (the time spent awake between the onset of sleep and the patient’s planed wake-up time). Improvements in these areas meant patients fell asleep faster and were better able to stay asleep without waking early.

Recommended dosing is 5mg taken once per night immediately before bed and at least seven hours before the planned wake-up time. If needed, the dose can be increased to 10mg per night based on clinical response and tolerability. The dose should not exceed 10mg once daily, and Dayvigo should not be taken more than once in a single night. The time to sleep onset after taking the medication may be delayed if it is taken with or soon after a meal.

Dayvigo has been submitted to the U.S. Drug Enforcement Agency (DEA) for classification as a controlled substance. Eisai plans to launch the product once the DEA has made its determination, which is expected to occur within 90 days of the drug’s FDA approval.