For those who suffer from insomnia, the answer is not simple. Of the few medications on the market, many cause a slew of unpleasant and sometimes dangerous side effects. However, recently the FDA approved a new insomnia medication that may serve as an alternative. The drug, named lemborexant (Dayvigo), was found to particularly help seniors stay asleep.
Dayvigo was approved for the treatment of insomnia in adults who demonstrated difficulty falling asleep and staying asleep. Drug makers believe the drug may be particularly beneficial to seniors suffering from sleep problems related to mild to moderate Alzheimer’s disease.
In studies, the Dayvigo was found to statistically improve sleep onset and keep patients asleep,when compared to the placebo. Dayvigo was also not found to cause rebound insomnia, a common problem with some sleep medications. This describes worsened sleep compared to the baseline after drug discontinuation. There was also no evidence of withdrawal effects.
The most common side effects reported was somnolence, also known as sleepiness or drowsiness.
“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 six-month period in a pivotal clinical study,” said Lynn Kramer, MD, Chief Clinical Officer, Neurology Business Group, Eisai in a press statement. “We look forward to making this new therapeutic option available to the millions of patients who suffer with insomnia.”
The medication is a dual orexin receptor antagonist, which works by inhibiting neurons that promote wakefulness. According to research, this type of drug is less likely to cause adverse side effects related to memory and cognition.
The drug also tested well in it’s “middle of the night safety.” This requires a drug to keep a patient asleep, but not work so well that they are not able to be awakened and alert in case of an emergency. There was no difference between Davigo and a placebo affecting patients’ abilities to awaken in the middle of the night to a sound. However, the drug did appear to affect the attention and memory of patients, as well as their balance. These effects were not found when patients were awakened after a full night of rest.
The drug still needs to be scheduled by the Drug Enforcement Agency. After this is done, it can then be prescribed to patients.
Insomnia is a common problem affecting an estimated 48 percent of Americans at some point in their lives. There are currently a number of sleeping medications available both by prescription and over the counter.
These medications have a sedative effect and help individuals fall asleep and stay asleep once knocked out. However, the drugs are not without their side effects, some of which are serious. For example, sleeping medications can have a high rate of misuse and abuse and can become addicting.