What are the adverse reactions of Lebraxen?

Lemborexant is an OX1/OX2 receptor antagonist of the protein-coupled orexin receptor, which is used to treat insomnia characterized by difficulty falling asleep and/or maintaining sleep. So, what are the adverse reactions of Lebraxen?

The safety of DAYVIGO was evaluated in 1,418 adults (aged 18-88 years) with insomnia disorder in two controlled efficacy trials (Study 1 and Study 2). Study 1 was a 6-month, placebo-controlled trial evaluating DAYVIGO 5 or 10 mg once nightly, followed by a 6-month parallel-group extension period in which patients initially treated with DAYVIGO continued to receive the same dose and patients who received placebo were rerandomized to receive DAYVIGO 5 or 10 mg once nightly. In Study 1, 434 patients received DAYVIGO for 1 year. Study 2 was a 30-day placebo and active-controlled trial evaluating DAYVIGO 5 or 10 mg once nightly.

Adverse reactions leading to treatment discontinuation

The frequency of discontinuation was 2.6% and 1.4% of patients receiving DAYVIGO 10 mg and 5 mg in Study 1 (first 30 days) and Study 2, respectively, compared with 1.5% in the placebo group. The most common adverse reactions leading to discontinuation of DAYVIGO were somnolence (1.0% in the 10 mg group, 0.7% in the 5 mg group, placebo) and nightmares (0.3% in the 10 mg group, 0.3% in the 5 mg group, and 0% in the placebo group).

During the 6-month placebo-controlled period of Study 1, the frequency of discontinuation due to adverse reactions was 8.3% and 4.1% of patients receiving dynamin 10 mg and 5 mg, respectively, compared with 3.8% in the placebo group. The most common reasons for discontinuing DAYVIGO and occurring in more than 1 patient in the treatment groups were somnolence (2.9% in the 10 mg group, 1.0% in the 5 mg group, and 0.6% in the placebo group), nightmares (1.3% in the 10 mg group, 0.3% in the 5 mg group, and 0% in the placebo group) and palpitations (0.6% in the 10 mg group, 0% in the 5 mg group, and 0% in the placebo group).

Most common adverse reactions

The most common adverse reaction in Study 1 (first 30 days) and Study 2 (occurring in ≥5% of patients treated with ELISA and at least 2 times the rate in the placebo group) was somnolence (10% in the 10 mg group, 7% in the 5 mg group, and 1% in the placebo group).

Table 1 lists the adverse reactions based on the pooled data from the first 30 days of Study 1 (6-month controlled efficacy trial) and Study 2 (1-month controlled efficacy trial), with an incidence rate of ≥2% in patients treated with this product and higher than in patients treated with placebo.

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