Evie Summers
Sleep is an essential part of our lives, and insomnia is a common condition that affects many individuals. While there are various medications available to help with insomnia, they often carry drawbacks such as the risk of dependency and side effects like drowsiness. However, a new treatment option, Daridorexant (Quviviq®), offers a different approach to helping adults with insomnia fall asleep faster and stay asleep longer. Another sleeping pill that has been approved by the FDA is Belsomra (suvorexant). Daridorexant belongs to a new class of drugs called DORAs, which work by reducing levels of wakefulness and avoiding the severe side effects and dependency issues of traditional treatments. It is clinically proven to improve sleep within just one week of nightly use and is designed to be taken consistently. While it is a promising option, long-term clinical trials are still needed to fully understand its effects.
| Characteristics | Values |
|---|---|
| Name | QUVIVIQ® (daridorexant) |
| Alternative names | Dayvigo® (lemborexant), Belsomra (suvorexant) |
| Intended use | Prescription treatment for adults with insomnia |
| Mechanism of action | Dual orexin type 1 and type 2 receptor antagonist |
| Dosage | 50 mg doses more effective than 25 mg doses |
| Side effects | Sleepiness, decreased awareness and alertness, risk of falls, drowsiness, dizziness, cognitive impairment |
| Contraindications | Patients with narcolepsy, patients with allergies to ingredients, patients over 65, patients taking other sleeping medications or sedatives |
| Interactions | Unknown, but may affect other medicines and vice versa |
| Addiction potential | Low risk of developing dependence |
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What You'll Learn
QUVIVIQ (daridorexant)
QUVIVIQ is available in tablet form and should be taken once each night, within 30 minutes of bedtime, and when the user can stay in bed for at least 7 hours. It is recommended that users follow their doctor's instructions for taking the medication. It is advised that QUVIVIQ should not be taken with food or right after a meal, and it works faster if taken on an empty stomach.
QUVIVIQ may cause serious side effects, including decreased awareness and alertness, sleepiness during the day, worsening of depression, and suicidal thoughts or actions. It may also cause hallucinations or a temporary inability to move or talk. The risk of these side effects is higher if the user takes more QUVIVIQ than prescribed, does not sleep a full night after taking a dose, or takes it with alcohol or other medicines that cause drowsiness. It is advised that users do not drive or perform other activities that require alertness or coordination until they know how QUVIVIQ affects them.
In clinical studies, people reported sleeping better after just 1 week of taking QUVIVIQ every night, and improvements continued to increase over 3-4 weeks. It is a relatively new drug, and studies will continue to examine its long-term effects.
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Belsomra (suvorexant)
Belsomra is an orexin receptor antagonist, which means that it alters the signalling of orexin in the brain. It is a dual orexin receptor antagonist (DORA), acting as a selective dual antagonist of the orexin OX1 and OX2 receptors. Unlike benzodiazepines and Z-drugs, suvorexant does not interact with GABA receptors and has a distinct mechanism of action.
The medication has an intermediate elimination half-life of 12 hours and a time to peak of about 2 to 3 hours. It is taken by oral administration and is indicated specifically for the treatment of insomnia in adults, characterised by difficulties with sleep onset and/or middle-of-the-night insomnia, total sleep time, and issues with sleep quality.
The effectiveness of Belsomra is considered modest, similar to that of other orexin antagonists but lower than that of benzodiazepines and Z-drugs. A 2017 systematic review and meta-analysis found that the medication improved sleep onset, total sleep time, and sleep quality when assessed at one to three months of treatment. The review also found that suvorexant increased total sleep time by increasing rapid eye movement (REM) sleep while having no effect on or even decreasing non-rapid eye movement (NREM) sleep.
Side effects of suvorexant include somnolence, excessive daytime sleepiness, headache, dizziness, abnormal dreams, dry mouth, and impaired next-day driving ability. Rarely, sleep paralysis, sleep-related hallucinations, complex sleep behaviours like sleepwalking, and suicidal ideation may occur. Tolerance, dependence, withdrawal, and rebound effects do not appear to be significant issues with the medication.
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DAYVIGO (lemborexant)
DAYVIGO is thought to treat insomnia by blocking certain signals believed to play a role in wakefulness. It is the second dual orexin receptor antagonist and blocks wake-promotion by blocking the binding of neuropeptides, orexin A, and orexin B. It is to be taken right before going to bed, preferably on an empty stomach, as food decreases its effectiveness.
DAYVIGO may cause serious side effects, including temporary sleep paralysis, hallucinations, cataplexy-like symptoms, and complex sleep behaviours such as walking, driving, or cooking while not fully awake. It should not be taken with other medicines that can make one sleepy or with alcohol, as these combinations may increase the risk of serious side effects. The morning after taking DAYVIGO, one's ability to drive safely and think clearly may be decreased, and sleepiness may persist throughout the day.
DAYVIGO has been shown to be safe and effective when taken nightly for up to one year, with less than 1% discontinuation rates with short-term use (two weeks) and less than 10% with long-term use (12 months). It has been compared with placebo and zolpidem for sleep onset and maintenance in two randomized, double-blind, placebo-controlled studies that included approximately 800 adults.
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CBT-I (cognitive-behavioural therapy for insomnia)
Cognitive Behavioral Therapy for Insomnia (CBT-I) is a proven and recommended treatment for insomnia. It is a multi-component treatment that targets difficulties with initiating and/or maintaining sleep. CBT-I focuses on restructuring the thoughts, feelings, and behaviors that contribute to insomnia. It is considered effective for both short-term and chronic insomnia.
During CBT-I, a trained provider helps to identify thoughts, feelings, and behaviors that contribute to insomnia. This involves examining thoughts and feelings about sleep and testing their accuracy, while also examining behaviors to determine if they promote sleep. The provider then clarifies or reframes misconceptions and challenges in a way that promotes restful sleep.
CBT-I typically involves 6-8 sessions, although the length may vary depending on individual needs. These sessions can happen weekly or biweekly. The sessions may include cognitive, behavioral, and educational components. The educational component involves learning about sleep and insomnia, including the differences between insomnia and other sleep problems. Behavioral interventions focus on changing habits to improve sleep, such as identifying and eliminating ineffective habits that may have initially been developed to improve sleep. Cognitive interventions aim to change thoughts that affect sleep by teaching patients to question unhelpful thoughts about sleep and replacing them with more adaptive, sleep-promoting thoughts.
Relaxation techniques are also commonly taught in CBT-I, such as breathing exercises that involve slow, deep breaths. These exercises have been shown to increase slow heart rate and breathing, reducing feelings of anxiety, anger, and depression. Homework is an important aspect of CBT-I, as the strategies learned in sessions require practice to become habits. This may include keeping a daily sleep diary to track sleep patterns and treatment progress, as well as improving sleep habits.
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Benzodiazepine receptor agonists (BZRA)
BZRA medications are rapidly absorbed, with a Tmax of 0.5 to 2 hours, which accounts for their capacity to hasten sleep onset. They differ widely in half-lives, and the half-life is predictive of the likelihood of producing residual effects. Among the benzodiazepine BzRAs, only triazolam has a short half-life. Temazepam and estazolam have intermediate half-lives, whereas flurazepam and quazepam have long half-lives. All of these intermediate and long-acting benzodiazepines have been shown to have residual effects.
The major pharmacological difference among the BzRAs is in their alpha receptor subtype binding affinity. For the alpha receptor of the GABAA complex, six subtypes have been identified. All of the benzodiazepines demonstrate a similar affinity for the alpha 1, 2, 3, and 5 receptor subtypes. In contrast, zolpidem and zaleplon have a higher affinity for alpha 1 than the other subtypes. Eszopiclone shows a decreased preference for the alpha 1 subtype, having a greater affinity for alpha 2 and 3. Based on animal studies, it is hypothesized that alpha 1 mediates sleep promotion and amnesic effects, whereas alpha 2 and 3 are involved in anxiolytic and possibly antidepressant effects.
An inability to remember information presented after drug administration, termed anterograde amnesia, is a characteristic of all BzRAs. It can be due to either attention failures or both attention and consolidation failures in the memory process. The severity of amnesia is related to plasma concentration at the time of stimulus presentation, which is determined by dose and time since drug ingestion. As there are currently no BzRAs that do not bind to the alpha 1 receptor, all available BzRAs are associated with amnesia.
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Frequently asked questions
The new sleeping pill is called Daridorexant (Quviviq®). It is a prescription medicine for adults with insomnia.
Daridorexant blocks the action of orexin, a substance produced by the brain that helps keep us awake. By inhibiting orexin, Daridorexant enables users to fall asleep faster and stay asleep longer.
Daridorexant has been found to have fewer side effects than traditional sleeping pills. It has a low risk of dependence and tolerance. However, it may cause decreased awareness and alertness the morning after, impacting activities like driving.
Daridorexant is recommended for adults with insomnia lasting three nights or more per week for at least three months, significantly affecting their daytime functioning. It is not suitable for those with narcolepsy or allergies to its ingredients.
