STEPS

New Drug Reviews

Suvorexant (Belsomra) for Insomnia

 

Am Fam Physician. 2016 Jun 15;93(12):1016-1020.

Suvorexant (Belsomra) is labeled for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. Unlike other hypnotics, it blocks the binding of neuropeptides (orexin A and B) that promote wakefulness. It is a schedule IV controlled substance.1

View/Print Table

DrugDosageDose formCost*

Suvorexant (Belsomra)

10 mg once daily within 30 minutes of bedtime; may increase to 20 mg once daily

5-, 10-, 15-, or 20-mg tablets

$305


*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed April 27, 2016).

DrugDosageDose formCost*

Suvorexant (Belsomra)

10 mg once daily within 30 minutes of bedtime; may increase to 20 mg once daily

5-, 10-, 15-, or 20-mg tablets

$305


*—Estimated retail price of one month's treatment based on information obtained at http://www.goodrx.com (accessed April 27, 2016).

SAFETY

Suvorexant carries a slight risk of abuse. Events that suggested possible abuse were identified in 3% to 4% of patients in clinical trials.2,3 Suvorexant is a central nervous system depressant. Rare side effects include sleep paralysis, hypnagogic hallucinations, and mild cataplexy, consisting of brief periods of leg weakness.2 Suvorexant should be avoided in patients with depression because it may worsen symptoms; patients with severe depression were excluded from clinical trials. It should also not be used in patients with narcolepsy, obstructive sleep apnea, or severe chronic obstructive pulmonary disease. It is a U.S. Food and Drug Administration pregnancy category C drug. It is unknown whether suvorexant is excreted in human breast milk.1

TOLERABILITY

Suvorexant causes significant somnolence in 7% to 11% of patients, and driving performance is impaired in up to 20% of patients, especially at higher doses and when starting the medication. Performance can be affected without the patient being aware.4 Taking suvorexant may also impair other mental or physical capabilities. These effects are dose-related and are heightened when suvorexant is combined with other depressants such as alcohol and opioids. Suvorexant may

Address correspondence to Andrea R. Gauld, PharmD, BCACP, BCPS, at agauld@ndm.edu. Reprints are not available from the author.

Author disclosure: No relevant financial affiliations.

REFERENCES

show all references

1. DailyMed. Drug label information. Belsomra–suvorexant tablet, film coated. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5b72731-1acb-45b7-9c13-290ad12d3951. Accessed November 18, 2015....

2. Michelson D, Snyder E, Paradis E, et al. Safety and efficacy of suvorexant during 1-year treatment of insomnia with subsequent abrupt treatment discontinuation: a phase 3 randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2014;13(5):461–471.

3. Herring WJ, Connor KM, Ivgy-May N, et al. Suvorexant in patients with insomnia: results from two 3-month randomized controlled clinical trials. Biol Psychiatry. 2016;79(2):136–148.

4. U.S. Food and Drug Administration. Suvorexant safety and efficacy. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/UCM354215.pdf. Accessed December 17, 2015.

5. Herring WJ, Snyder E, Budd K, et al. Orexin receptor antagonism for treatment of insomnia: a randomized clinical trial of suvorexant. Neurology. 2012;79(23):2265–2274.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, Contributing Editor.

A collection of STEPS published in AFP is available at http://www.aafp.org/afp/steps.


 

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