Clinical Trial Explores Sleep Aid for Alcohol Use Disorder

Getting a good night’s sleep is challenging for people in recovery from alcohol use disorder. Lying in bed missing the familiar drink that once eased sleep, the night feels restless, and the next day proves exhausting. This all-too-common struggle can derail recovery, affecting thinking, mood and physical well-being.

 

“In the first month after you stop using alcohol, your sleep and how you feel is still pretty messed up. Your brain is still adjusting to this new state,” says Kelly Truong, MD, a staff psychiatrist with Menninger’s Addictions Services team.

 

She explains that many people start drinking due to sleep issues, forming a habit that, while initially helpful, leads to restless sleep. As alcohol breaks down, it causes rebound anxiety or insomnia during the night.

 

“This creates a vicious cycle where the belief becomes, ‘I need alcohol to sleep, but I feel tired during the day. If I don't have alcohol, I can't get any sleep at all.’ So, continuing to drink just seems like the best option and can trigger a relapse," Truong says.

 

With seed funding from donors, Truong and a team of Menninger researchers conducted a double-blind clinical trial to investigate if combining the medications naltrexone and lemborexant can improve sleep, reduce cravings and decrease the urge to turn to alcohol during vulnerable times. The study is part of Menninger’s ongoing efforts to advance the treatment of substance use disorders. Boosting clinical trials, like Truong’s, is pivotal to this initiative.

 

While naltrexone has a three-decade track record of effectively reducing alcohol cravings and lowering the risk of relapse, it can exacerbate sleep issues — and that's where lemborexant steps in. Lemborexant is a long-used sleep aid belonging to a class of drugs called orexin antagonists. These medications work by blocking orexin, a chemical messenger in the brain that plays a role in both insomnia and addiction. It’s possible that orexin antagonists, like lemoborexant, may also help to reduce alcohol cravings.

 

 

As a bonus, naltrexone and lemborexant are both FDA approved, streamlining access to the treatment if the combination proves effective.

 

The clinical trial, which was recently completed, randomly assigned eight hospitalized patients who consented to the study into two groups: one taking the combination therapy, and the other taking naltrexone and a placebo. To mimic a real-world environment, each participant engaged in virtual reality scenarios with common alcohol use triggers, such as celebrating with friends at a bar or having an argument.

 

The research team measured participants’ cravings and administered medications weekly to see if cravings diminished over time. They also tracked participants’ sleep quality using a wristwatch-like wearable device to collect data, like movements during sleep and heart rate. Next steps involve analyzing the data to assess the treatment’s safety and efficacy, laying the groundwork for larger clinical trials.

 

Truong says donor funding played a crucial role in launching the trial by covering essential components like medications and the virtual reality service. She emphasizes the need for diverse treatment approaches for substance use disorders, stressing that combining therapies is more effective than using them alone.

 

There’s an urgent need for better treatments, considering that more than 1 in 6 people over the age of 12 had a substance use disorder in the past year, according to the 2022 National Survey on Drug Use and Health. At Menninger, almost 65% of patients have a substance use disorder, either as their sole diagnosis or as a co-occurring condition.

 

"In our community, substance use disorders are widespread and challenging to address,” Truong says. “It's crucial to approach them with the same intensity as any other psychiatric condition."