From the FDA Drug Label
- 1 Controlled Substance QUVIVIQ contains daridorexant, a Schedule IV controlled substance.
- 2 Abuse Drug abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. The abuse potential of daridorexant was evaluated in preclinical models, recreational sedative drug users, and insomnia subjects In a human abuse potential study conducted in 63 recreational sedative drug users, the effect of single-dose administration of QUVIVIQ [50 mg, 100 mg (two times the maximum recommended dose), and 150 mg (three times the maximum recommended dose)], zolpidem (30 mg), suvorexant (150 mg), and placebo on subjective rating of "drug liking" was evaluated At the dose of 50 mg, QUVIVIQ showed significantly lower "drug liking" ratings than zolpidem (30 mg) and suvorexant (150 mg), but significantly higher than placebo. Because individuals with a history of abuse of or addiction to alcohol or other drugs may be at increased risk for abuse of or addiction to QUVIVIQ, follow such patients carefully.
Quviviq (daridorexant) has the potential to be habit-forming, as it is classified as a Schedule IV controlled substance. However, studies have shown that at the recommended dose of 50 mg, it has lower "drug liking" ratings compared to other sedatives like zolpidem and suvorexant. Nevertheless, individuals with a history of substance abuse or addiction should be monitored closely when taking Quviviq 1.
- Key points:
- Quviviq is a Schedule IV controlled substance
- It has lower abuse potential compared to other sedatives at the recommended dose
- Individuals with a history of substance abuse or addiction should be monitored closely
- Quviviq can be habit-forming, and its use should be approached with caution.
From the Research
Quviviq (daridorexant) has a low potential for abuse and dependence, as demonstrated by a recent study published in 2023 2. The study found that daridorexant had no reinforcing effects, was dissimilar to zolpidem in a drug discrimination task, and did not induce any withdrawal-related signs upon treatment discontinuation in rats. This suggests that the risk of habit formation is relatively low. However, as with any medication, it is essential to use Quviviq exactly as prescribed by a healthcare provider, at the lowest effective dose (25-50 mg once daily at bedtime) and for the shortest duration necessary. Patients with a history of substance abuse may still be at higher risk for developing dependence, and healthcare providers should monitor them closely. Additionally, a long-term safety and tolerability study of daridorexant found that treatment with the medication for up to 12 months was generally safe and well tolerated, with no new safety signals or concerns of withdrawal-related symptoms or rebound insomnia 3. Key points to consider when using Quviviq include:
- Taking the medication exactly as prescribed
- Using the lowest effective dose
- Limiting the duration of treatment
- Monitoring for signs of dependence, such as tolerance or withdrawal symptoms
- Gradually reducing the dose when stopping treatment to minimize withdrawal symptoms, as recommended by a healthcare provider.