FDA News

FDA OKs Eisai’s insomnia drug, Dayvigo

The FDA approved Dayvigo 5 mg and 10 mg to treat adults with insomnia, according to a press release from the manufacturer.

Dayvigo, (lemborexant, Eisai) is a small-molecule compound that inhibits orexin signaling by binding competitively to both orexin receptor subtypes, according to the release.

“We believe the approval of Dayvigo is particularly exciting because it is the first FDA-approved medication to report safety data over a 12-month period along with sleep onset and sleep maintenance efficacy data over a 6-month period in a pivotal clinical study,” said Lynn Kramer, MD, chief clinical officer of Eisai’s neurology business group.

According to Eisai, the FDA primarily based its decision on findings from two phase 3 randomized trials in which lemborexant met its primary efficacy endpoints — including the estimated time it took for patients to attempt to sleep until sleep onset, and the number of minutes from “lights off” to the first 10 consecutive minutes of nonwakefulness, measured from baseline to the end of treatment. In both trials, the drug was not associated with rebound insomnia following treatment discontinuation, and there was no evidence of withdrawal effects following lemborexant discontinuation at either dose.

The most common adverse event in patients treated with lemborexant was somnolence, Eisai stated. The most common adverse events that caused patients to stop taking lemborexant were somnolence and nightmares.

According to Eisai, the FDA has recommended that lemborexant be classified as a controlled substance. Eisai said lemborexant will be commercially available following the DEA’s scheduling, which is expected to occur within 90 days. – by Janel Miller

Disclosure: Kramer is employed by Eisai.

The FDA approved Dayvigo 5 mg and 10 mg to treat adults with insomnia, according to a press release from the manufacturer.

Dayvigo, (lemborexant, Eisai) is a small-molecule compound that inhibits orexin signaling by binding competitively to both orexin receptor subtypes, according to the release.

“We believe the approval of Dayvigo is particularly exciting because it is the first FDA-approved medication to report safety data over a 12-month period along with sleep onset and sleep maintenance efficacy data over a 6-month period in a pivotal clinical study,” said Lynn Kramer, MD, chief clinical officer of Eisai’s neurology business group.

According to Eisai, the FDA primarily based its decision on findings from two phase 3 randomized trials in which lemborexant met its primary efficacy endpoints — including the estimated time it took for patients to attempt to sleep until sleep onset, and the number of minutes from “lights off” to the first 10 consecutive minutes of nonwakefulness, measured from baseline to the end of treatment. In both trials, the drug was not associated with rebound insomnia following treatment discontinuation, and there was no evidence of withdrawal effects following lemborexant discontinuation at either dose.

The most common adverse event in patients treated with lemborexant was somnolence, Eisai stated. The most common adverse events that caused patients to stop taking lemborexant were somnolence and nightmares.

According to Eisai, the FDA has recommended that lemborexant be classified as a controlled substance. Eisai said lemborexant will be commercially available following the DEA’s scheduling, which is expected to occur within 90 days. – by Janel Miller

Disclosure: Kramer is employed by Eisai.