Have Trouble Sleeping? Consider Belsomra

1
FDA Approves Belsomra for Sleep

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Every year, an estimated 35% of all Americans are tortured by insomnia or other sleep-related disorders.  Ten to 15 percent of these people go on to have chronic insomnia which requires medical attention.  Moreover, chronic insomnia doubles lifetime mortality (death) risk and increases the risk for other chronic illnesses like depression, hypertension and diabetes.  Alarmingly, insomnia is not only a disease that harms individuals but also poses a threat to the public.  More specifically, people with daytime sleepiness secondary to insomnia are more likely to cause industrial and motor vehicle accidents.  

Insomnia is treated with both drugs and behavioral therapy.  In August 2014, the FDA approved Belsomra (suvorexant), a new type of drug that has proven effective in helping people fall sleep and stay asleep longer.  

2
Some Facts on Insomnia

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Insomnia is generally defined as problems with initiating sleep, staying asleep (frequent or prolonged awakenings) and unrefreshing sleep.  Chronic insomnia develops when a person becomes conditioned to an arousal state which is irreconcilable with sustained and restorative sleep. 

There can be many reasons why a person develops insomnia over time including somatic illness, psychiatric illness, drugs, lifestyle issues, primary sleep disorders (obstructive sleep apnea, restless leg syndrome, and so forth).  Oftentimes, the etiology of insomnia is multifactorial with many causes playing a role. 

When diagnosing insomnia, a detailed history (possibly including a sleep diary) is key with particular attention paid to "alarm symptoms" like chest pain, heavy snoring, suicidal thoughts and so forth.  Such alarm symptoms help the clinician ascertain the severity of a possible underlying cause.

Here is a list of insomnia symptoms:

  • fatigue
  • daytime sleepiness
  • low energy
  • problems with memory and concentration
  • irritability
  • headache
  • depressed, anxious or combative mood

When treating insomnia, it's important that the clinician treats any underlying conditions or disease that may be causing or contributing to the insomnia.  Nonpharmacologic approaches are preferred to pharmacologic ones and center on reframing the context of sleep.  For example, if you or someone you love has problems with sleep, consider better sleep habits or sleep hygiene: routine bed times, avoidance of alcohol or illicit drugs, daily exercise, a comfortable sleep environment and more.  Moreover, long-term cognitive behavioral therapy, which aims to change beliefs that cause anxiety which interferes with sleep, has been proven to be just as effective as sleep medication.

Here is a list of commonly prescribed sleep medications:

  • benzodiazepines (Halcion)
  • benzodiazepine receptor agonists (Ambien)
  • melatonin agonists
  • sedating antidepressants (trazodone)
  • antihistamines

Finally, with those people who have a problem with their sleep-wake cycle (circadian rhythm), therapy with natural or artificial light may help.

3
What is Belsomra?

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Belsomra belongs to a new class of drugs which inhibit the orexin neuropeptide signalling system.  Whereas most sleep medications induce sleep by activating the (inhibitory)

GABAA receptor, Belsomra acts as an orexin antagonist and blocks the neurotransmitter orexin which mediates wakefulness.  In other words, most sleep medications help by directly inducing sleep; whereas, Belsomra helps by inhibiting wakefulness. 

Assumably, Belsomra should have fewer adverse effects than drugs which work on GABAA because stimulation of GABAA receptors can also cause sleep walking and other disconcerting and dangerous behaviors while asleep including eating, driving and even having sex.  However, as pointed out by the FDA, Belsomra has never actually been compared with other drugs in a clinical research setting: "Belsomra was not compared to other drugs approved to treat insomnia, so it is not known if there are differences in safety or effectiveness between Belsomra and other insomnia medications."

In clinical trials, participants who had been taking Belsomra for one year reported that after discontinuing the drug for 2 months, it took, on average, almost 15 extra minutes to fall sleep.  Furthermore, these participants slept almost 22 minutes less than those research participants who were still taking the drug.

During clinical trials, researchers identified that a significant number of participants who took the highest dose (20 mg) had difficulties with driving the following day.  If you or someone you know is planning on taking Belsomra, it's important to keep safety in mind and exhibit caution with driving or other activities that require full mental acuity.

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Final Thoughts on Insomnia and Belsomra

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If you or someone you love battles insomnia, it's important to receive proper counseling and treatment.  Keep in mind that 60% of insomnia cases go unrecognized by internists and family medicine physicians and fewer than half of these physicians take sleep histories so it pays to remain vigilant when seeking help.

Although Belsomra can help with sleep, it's no silver bullet in the fight against chronic insomnia.  Rather this drug, like any other sleep medication, is a single modality that works best with other interventions including proper sleep hygiene, treatment of underlying medical conditions and even cognitive behavioral therapy.

Selected Sources

Hardin KA, Antonson K, McBride AB, Young JS. Chapter 94. Insomnia: Assessment and Management of Sleep Disorders. In: McKean SC, Ross JJ, Dressler DD, Brotman DJ, Ginsberg JS. eds. Principles and Practice of Hospital Medicine. New York, NY: McGraw-Hill; 2012.  Accessed October 27, 2014.

Keenan CR. Chapter 10. Insomnia. In: Henderson MC, Tierney LM, Jr., Smetana GW. eds. The Patient History: An Evidence-Based Approach to Differential Diagnosis. New York, NY: McGraw-Hill; 2012. Accessed October 27, 2014

“Insomniacs get new mechanism sleep drug Belsomra” by Cormac Sheridan published in Nature Biotechnology on 10/9/2014.  Accessed from PubMed on 10/28/2014.

Singer CM, Applebee GA. Chapter 28. Sleep Disorders. In: Feldman MD, Christensen JF. eds. Behavioral Medicine: A Guide for Clinical Practice, 3e. New York, NY: McGraw-Hill; 2008.  Accessed October 27, 2014.

 

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