(BPT) – Many people have experienced the negative impact of a poor night’s sleep, often referred to as “waking up on the wrong side of the bed.” In fact, studies show that as many as 30% of adults worldwide have experienced insomnia symptoms and 10% of patients have insomnia disorder.[1] Insomnia is on the rise due to the pandemic and the massive upheavals people are experiencing to their everyday routines.[2]

“Based on my experience, the myriad of shifts in our day-to-day lives as a perfect storm for sleep challenges,” said Russell Rosenberg, Ph.D., D.ABSM, sleep specialist and former chair of the Board of the National Sleep Foundation.

What factors contribute to insomnia?

Insomnia, an inability to fall and/or stay asleep, can be influenced by many things, including lifestyle habits (i.e. caffeine intake and lack of a wind-down routine), as well as a person’s sleeping environment (i.e. bedroom temperature).[3]

Certain types of brain functioning may also impact sleep, such as the inability to turn down wake signals in the brain. These wake signals are regulated by a neuropeptide in the brain called orexin.

“Orexin signaling is believed to promote periods of wakefulness. For people who frequently struggle with sleep, it is possible that orexin signaling is not functioning normally,”[4] said Rosenberg.

How do medical experts diagnose insomnia disorder?

For adults who have insomnia disorder, obtaining the recommended seven to eight hours of sleep per night may seem like an impossible task.[5]

A healthcare provider might diagnose you with insomnia disorder if you:

  • Have trouble falling asleep or staying asleep for three out of seven nights each week for a period of at least three months.[6]
  • Struggle socially, at work, in school or in other important areas of functioning due to your insomnia.6

What are the options for treating insomnia disorder?

“We must continue to give sleep the attention it deserves as we seek to combat the negative effects of the COVID-19 environment on our health and wellbeing,” said Rosenberg. “People struggling with sleep consistently should take it seriously and make an appointment with a doctor or healthcare professional to see if they may be struggling with insomnia disorder. Once this initial step is taken, the conversation can begin about what treatment options may be best.”

Doctors have several options when treating patients with insomnia disorder, but often start with the least invasive treatment approach.[7] Cognitive behavioral therapy for insomnia, known as CBT-I, typically includes “sleep restriction” (i.e. limiting the amount of time people spend in bed when they are unable to sleep) and “stimulus control” (i.e. keeping the bedroom dedicated to sleep and sex, as well as getting out of bed when you can’t sleep).7

For people who cannot manage their symptoms through behavioral and/or environmental changes, there are several prescription treatment options which may be considered when discussing your symptoms with a doctor.

Four main classes of prescription medications are used to treat sleep issues: sedatives, antidepressants, melatonin agonists and orexin receptor antagonists.[8] Each class has a different mechanism of action that affects the central nervous system in a specific way.8

Orexin receptor antagonists (blockers) belong to a class of medications that inhibit the effect of orexin, a chemical in the brain that plays an important role in keeping people awake.4 In people with normal daily sleep-wake rhythms, orexin signaling is believed to promote periods of wakefulness.4

DAYVIGO® (lemborexant) CIV 5mg and 10mg tablets, a prescription medication, is part of this class of orexin receptor antagonists and is a prescription medicine for adults age 18 years and older who have trouble falling or staying asleep (insomnia).[9] In a clinical trial, patients reported falling asleep faster and staying asleep longer with DAYVIGO.9

“It is crucial to offer patients treatment options that may help them fall asleep and stay asleep,” said Dr. Rosenberg.

Do not take DAYVIGO if you fall asleep often at unexpected times (narcolepsy). Please see additional Important Safety Information below. To learn more about DAYVIGO visit https://www.dayvigo.com/.

As we continue to deal with the pandemic, adequate sleep is an important aspect of health and wellbeing that many will struggle with handling. It’s important for patients to speak with their doctor to determine which treatment approach is best for them. All prescription medications should be used as directed by the prescribing doctor.

Important Safety Information

DAYVIGO may cause serious side effects including:

  • decreased awareness and alertness. The morning after you take DAYVIGO, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day. Do not take more DAYVIGO than prescribed. Do not take DAYVIGO unless you are able to stay in bed for a full night (at least 7 hours) before you must be active again. Take DAYVIGO right before going to bed.

Do not take DAYVIGO if you fall asleep often at unexpected times (narcolepsy).

DAYVIGO is a federally controlled substance because it can be abused or cause dependence.

Before taking DAYVIGO, tell your healthcare provider about all of your medical conditions, including if you:

  • have a history of depression, mental illness, or suicidal thoughts; drug or alcohol abuse or addiction; a sudden onset of muscle weakness (cataplexy); daytime sleepiness
  • have lung problems or breathing problems, including sleep apnea
  • have liver problems
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

  • Taking DAYVIGO with certain other medicines can cause serious side effects. DAYVIGO may affect the way other medicines work and other medicines may affect the way DAYVIGO works.
  • Do not take DAYVIGO with other medicines that can make you sleepy unless your healthcare provider tells you to.

What should I avoid while taking DAYVIGO?

  • Do not drink alcohol while taking DAYVIGO. It can increase your chances of getting serious side effects.
  • Do not drive, operate heavy machinery, do anything dangerous, or other activities that require clear thinking if you take DAYVIGO and have had less than a full night of sleep (at least 7 hours) or if you have taken more DAYVIGO than prescribed by your healthcare provider.
  • You may still feel drowsy the next day after taking DAYVIGO. Do not drive or do other dangerous activities until you feel fully awake.

DAYVIGO may cause serious side effects, including:

  • temporary inability to move or talk (sleep paralysis) for up to several minutes while you are going to sleep or waking up
  • temporary weakness in your legs that can happen during the day or at night
  • complex sleep behaviors such as sleep-walking, sleep-driving, preparing and eating food, making phone calls, having sex or doing other activities while not fully awake that you may not remember the next morning.
  • worsening depression and suicidal thoughts have happened during treatment with DAYVIGO.

The most common side effect of DAYVIGO is sleepiness.

These are not all of the possible side effects of DAYVIGO. Call your doctor for medical advice and if you have any new or worsening side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information about DAYVIGO, see full Prescribing Information.

Price disclosure information for prescribers is available here.

References

[1] Ferrie JE, et al. Sleep epidemiology – a rapidly growing field. Int J Epidemiol. 2011;40(6):1431–1437.

[2] America’s State of Mind: U.S. trends in medication use for depression, anxiety and insomnia. Express Scripts. April 2020.

[3] National Sleep Foundation. Sleep Hygiene. Updated August 14, 2020. Accessed at https://www.sleepfoundation.org/articles/sleep-hygiene.

[4] Scammell TE, Winrow CJ. Orexin Receptors: Pharmacology and Therapeutic Opportunities. Annu Rev Pharmacol Toxicol. 2011; 51: 243–266.

[5] Cappuccio FP, et al. Sleep duration and all-cause mortality: a systematic review and meta-analysis of prospective studies. Sleep. 2010;33(5):585-592.

[6] American Psychiatric Association. Diagnostic and statistical manual of mental disorders: DSM-5. Arlington, VA: American Psychiatric Publishing, 2013.

[7] Cognitive Behavioral Therapy for Insomnia (CBT-I). SAMHSA. March 2018.

[8] Lie JD, Tu KN, Shen DD, Wong BM. Pharmacological treatment of insomnia. P T. 2015 Nov;40(11):759-768, 771.

[9] Eisai Inc. DAYVIGO Full Prescribing Information. 2019.

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