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DAYVIGO® stabilizes the sleep architecture and thereby increasing the satisfaction in the quality of sleep
DAYVIGO® temporarily blocks a pathway (Orexin Signals) in your brain which keeps you awake at night. This can help you fall asleep, stay asleep, and may help you perform your daily routine the next.
DAYVIGO® can help you sleep better.
- By reducing the time to fall asleep
- By reducing the frequent awakening
- By increasing the total sleep time
- By increasing satisfaction of sleep quality
- As per the clinical trials data, Lemborexant significantly reduces the initial time to fall asleep by 19 to 32 minutes and also maintains the sleep by reducing the time to wake after falling asleep by 44 to 51 minutes
- One year long study of Lemborexant showed sustained results overtime, with no signs of tolerance or physical dependence
As per the clinical trial data:
- There was no change in the postural stability seen in morning in the patients taking Lemborexant
- The cognitive parameters like memory and attention were not impacted in patients taking Lemborexant
- There was no significant impairment in the driving ability 9 hours after taking Lemborexant
In Special Safety Studies conducted to assess both short term and long term safety, DAYVIGO® demonstrated:
- No Physical Dependence
- No Rebound Insomnia & No Signs of Withdrawal on discontinuation
- No significant impairment of next morning cognitive abilities
Adverse Reactions
Based on the pooled analysis data from Phase 3 trials (SUNRISE 1 and SUNRISE 2), the most common adverse reactions, reported in ≥2% of DAYVIGO®-treated patients and at a greater frequency during the first 30 days of treatment were:
| Adverse Reactions | Dayvigo® 5 mg | Dayvigo® 10 mg |
|---|---|---|
| somnolence or fatigue | 6.9% | 9.6% |
| Headache | 5.9% | 4.5% |
| Nightmares or abnormal dreams | 0.9% | 2.2% |
The rate of somnolence was higher in patients 65 years or older treated with DAYVIGO® 10 mg (9.8%) compared with patients younger than 65 years (7.7%). Hence, Exercise caution when using doses higher than 5 mg in patients ≥65 years old
In case you experience any adverse reaction, kindly contact your healthcare practitioner
Reference:
- Rosenberg R et al. JAMA Netw Open. 2019;2(12):e1918254.
- Koren D, Dumin M, Gozal D. Role of sleep quality in the metabolic syndrome. Diabetes Metab Syndr Obes. 2016;9:281-310.
- Kärppä M et al. Sleep. 2020;zsaa123. doi:10.1093/sleep/zsaa123
- Murphy P, Kumar D, Zammit G, Rosenberg R, Moline M. Safety of lemborexant versus placebo and zolpidem: effects on auditory awakening threshold, postural stability, and cognitive performance in healthy older participants in the middle of the night and upon morning awakening. J Clin Sleep Med. 2020 May 15;16(5):765-773.
- Vermeeren A, Jongen S, Murphy P, Moline M, Filippov G, Pinner K, Perdomo C, Landry I, Majid O, Van Oers ACM, Van Leeuwen CJ, Ramaekers JG, Vuurman EFPM. On-the-road driving performance the morning after bedtime administration of lemborexant in healthy adult and elderly volunteers. Sleep. 2019 Apr 1;42(4):zsy260.