Suvorexant May Improve Insomnia With Alzheimer Disease

In continuation of my update on Suvorexant

Suvorexant improves total sleep time (TST) in patients with probable Alzheimer disease (AD) dementia and insomnia, according to a study published online Jan. 15 in Alzheimer's & Dementia.

W. Joseph Herring, M.D., Ph.D., from Merck & Co., in Kenilworth, New Jersey, and colleagues randomly assigned patients with both probable AD dementia and insomnia to four weeks of suvorexant 10 mg (136 patients; could be increased to 20 mg based on clinical response) or placebo (141 patients). Overnight polysomnography in a sleep laboratory was used to assess TST.

The researchers found that at week 4, the mean improvement from baseline in TST was 73 minutes for the suvorexant group and 45 minutes for the placebo group. Patients taking suvorexant were twice as likely to show an improvement of ≥60 minutes in TST compared with those taking placebo. In suvorexant-treated patients, somnolence was reported by 4.2 percent of participants versus 1.4 percent of placebo-treated patients.

"Suvorexant did not appear to impair next-day cognitive or psychomotor performance as assessed by objective tests, although these assessments do not constitute a comprehensive assessment of cognition," the authors write.

Several authors disclosed financial ties to pharmaceutical companies, including Merck, which manufactures suvorexant and funded the study.

https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.12035

https://en.wikipedia.org/wiki/Suvorexant

Merck Receives Complete Response Letter for Suvorexant, Merck’s Investigational Medicine for Insomnia

In continuation of my update on Suvorexant

Drug offers alternative treatment strategy for insomnia

In continuation of my update on  suvorexant

The team, led by W Joseph Herring (Merck Sharp & Dohme Corp, Whitehouse Station, New Jersey, USA), studied the effects of the orexin receptor antagonist suvorexant in treating 254 people aged 18 to 64 years with moderately severe insomnia.

The participants were randomly assigned to take either suvorexant, at doses of 10, 20, 40, or 80 mg, or placebo for 4 weeks, after which they switched to the alternative treatment for a further 4 weeks.

Their sleep was monitored in a sleep laboratory on the first night of taking each treatment and again in the fourth week of each treatment.

Sleep efficiency, reflecting the time patients spent in bed at night asleep, was an average 66% (with an average total sleep time of 316 minutes) before treatment and improved by a significant 5.2% to 12.9% on the first night of treatment with suvorexant, compared with placebo.

Suvorexant (see structure)  treatment also resulted in patients experiencing 21 to 37 fewer minutes awake during the first night when compared with placebo.

The benefits of suvorexant were maintained over the 4 weeks of the study, with a significant 4.7% to 10.4% improvement in sleep efficiency, compared with placebo.

For both outcomes, the effect was dose-related and all doses were superior to placebo for improving sleep efficiency on night 1 and at the end of week 4. Dose-related effects were also seen for sleep induction (latency to persistent sleep) and maintenance (wake after sleep onset). The researchers note that, overall, suvorexant was well tolerated. The most common adverse event associated with the drug was somnolence, which showed a dose-related increase.

But there was no consistent evidence of rebound insomnia or withdrawal effects after 4 weeks of treatment, or for next-day residual effects.

"This study provides evidence that suvorexant may offer a successful alternative strategy for treating insomnia," Herring said in a press statement.

Drug offers alternative treatment strategy for insomnia

Insomnia Drug Closer to Approval | News | Drug Discovery and Development Magazine

Merck & Co. said that its experimental insomnia drug suvorexant (see structure) helped patients fall asleep faster and stay asleep longer in two late-stage tests of the drug, seen as a potential blockbuster in a multibillion-dollar market. 

Merck said the drug worked better than a placebo at measurements including total sleep time, time to falling asleep, and continuous sleep after one month and three months of treatment. The company said patients reported better results on suvorexant compared with placebo, and their sleeping habits also were measured electronically.

Suvorexant is a new type of insomnia drug designed to help patients sleep while minimizing morning grogginess. It is one of Merck's major drug candidates. The company plans to file for U.S. marketing approval this year, and it is one of six planned product filings for Merck in 2012 and 2013.

The two trials involved more than 2,000 patients who had insomnia that was not caused by another medical problem. The most common side effects of suvorexant were tiredness and headache.
 

Insomnia Drug Closer to Approval | News | Drug Discovery and Development Magazine