Insomnia is persistent difficulty starting or maintaining quality sleep.
It is a very frequent pathology in the general population, it is estimated that between 25 and 35% of adults have suffered occasional or transient insomnia, while between 10 and 15% suffer from chronic insomnia. For these latter cases, the arrival of a new drug on the market seems to offer a solution.
Daridorexant, a medication manufactured by Idorsia Pharmaceuticals, belongs to a class of drugs known as dual orexin receptor antagonists. In January 2022, it received approval from the US Food and Drug Administration (FDA) to treat chronic insomnia in adults, and will be marketed from Mayo under the name QUVIVIQ.
This decision was reached after knowing the results of phase 3 trials, published in The Lancet Neurologywhich enrolled 1,854 adults aged 18 years and older with insomnia at 154 clinical trial sites in 17 countries.
The research consisted of participants receiving Daridorexant, in doses of 10, 25 or 50 mg, or a placebo, once a day (in the evening), for 3 months. Criteria for treatment efficacy were change from baseline to month 1 and month 3 in sleep quality measures: Latency to Persistent Sleep and Wake After Sleep Onset, objectively controlled by polysomnography in a sleep laboratory .
- Natural remedies to sleep well and avoid insomnia
After completion of the treatment period, the investigators found that the 25 and 50 mg doses showed a statistically significant improvement in measurements versus placebo at both month 1 and month 3. However, the 10 mg dose did not show significant improvements in measurements, so it was not approved by the FDA.
The 50 mg dose also showed a significant reduction in daytime sleepiness compared to placebo.
Other works, such as those published in neurology, Psychopharmacology Y sleeping, also showed positive results after analyzing the effects of Daridorexant in people with chronic insomnia. They detailed that Daridorexant is a safe drug that does not generate tolerance and does not cause drowsiness the next day.
How does Daridorexant work?
Daridorexant is used to treat chronic insomnia by only blocking the activation of orexin receptors, a hormone that maintains wakefulness. This allows sleep to occur, keeping its structure intact in all its phases.
This is a big difference from traditional sleep aids such as benzodiazepines, which cause extensive inhibition of brain activity, shortening the time it takes to fall asleep, prolonging the time spent asleep, and generally reducing wakefulness.
However, its use tends to worsen sleep quality by increasing light sleep and decreasing deep sleep. Another disadvantage of benzodiazepines is possible tolerance to their effects, rebound insomnia, reduced slow-wave sleep, and the fact that withdrawal is characterized by rebound insomnia and a prolonged period of anxiety and agitation.
In addition, due to the risk of generating dependency, the use of benzodiazepines is usually recommended only for a period of two to four weeks, unlike Daridorexant, which was tested for months in the participants of the different investigations.
The recommended dose of Daridorexant is one 50 mg tablet to be taken orally at night, about 30 minutes before bedtime. For patients with moderate hepatic impairment or those taking other medications, eg moderate CYP3A4 inhibitors, the recommended dose is 25 mg per night.
Is it safe to take Daridorexant?
The approval and marketing of Daridorexant generated a revolution in certain scientific and media circles, since it is easy to take, appears to be safe, does not generate tolerance and does not cause drowsiness the next day.
In turn, these results are supported by studies of good quality, with significant samples of participants, although tending to concentrate on older adults. Despite this effectiveness, many experts agree that this issue should be treated with caution.
As it is a new treatment, its long-term effects are still unknown (headaches, hallucinations, drowsiness, dizziness, sleep paralysis, nausea, and fatigue were reported in the investigations, although infrequent).
Specialists in sleep problems point out that taking a medication is not a definitive solution. It is necessary to work on the factors behind lack of sleep, which affects millions of people in the world.
Managing stress is the first step to improving sleep quality, and to achieve this, adopting a healthy lifestyle is essential. This should include:
- A balanced diet, rich in vegetable fruits, cereals and legumes.
- Exercise regularly.
- Maintain sleep schedules (go to bed and wake up at the same time every day).
- Try to make the sleeping environment as pleasant as possible.
- Avoid electronic devices before bed.
- Do not eat or drink excessively at night.
- Learn to recognize and handle stressful situations. For this, relaxation techniques or practices, such as yoga, deep breathing or meditation can be very useful.
Sources consulted: American Academy of Sleep Medicine, US National Library of Medicine, Mayo Clinic, SleepFoundation.