Belsomra (suvorexant) for Insomnia: Cost, Side Effects, Dosage and Prescribing Information | Rachael Olsufka, PharmD | RxEconsult

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Belsomra (suvorexant) Sleep Drug FDA Approval, Cost, Side Effects, Dosage for Insomnia Category: Sleep Disorders by - August 21, 2014 | Views: 71974 | Likes: 0 | Comment: 2  

IBelsomra (suvorexant) for insomnia


Brand Name: Belsomra
Generic Name: suvorexant tablets

Medication Class: Dual orexin receptor antagonist (DORA)
Similar Drugs: Belsomra is the first and only dual orexin receptor antagonist approved in the US
Manufacturer: Merck & Co. Inc.
FDA Approval date: August 13, 2014

What is Belsomra and its mechanism of action?

Belsomra (suvorexant) is new sleep drug for treating insomnia. It is a dual orexin receptor antagonist (DORA) that blocks orexin A and orexin B from binding the OXR1 and OXR2 receptors. Orexin also referred to as hypocretin, is a naturally occurring chemical produced in the hypothalamus. The hypothalamus is an area of the brain that controls sleep, body temperature, and several other bodily processes. Wakefulness and arousal are experienced when orexins are produced in the brain. Belsomra works by binding to the orexin A and orexin B chemicals thereby preventing them from binding to their respective receptors (OX1R and OX2R). By preventing orexins from binding to their respective receptors, Belsomra reduces wakefulness in persons experiencing insomnia, thus helping them fall asleep faster and stay asleep longer.

What is Belsomra approved for treating?

Belsomra is approved for treatment of insomnia, a common sleep condition characterized by difficulty falling asleep and/or staying asleep. The National Institute of Health estimates approximately 60 million Americans suffer from insomnia each year.

How effective is Belsomra?

Belsomra was studied in two randomized, double-blind, placebo-controlled clinical studies in adults (18-64 years old) and elderly (≥65 years old) patient populations over a period of 3 months. Belsomra was compared to placebo for both the time to fall asleep and time to stay asleep using both subjective and objective measurements. The subjective measurement was patient reported time to fall and stay asleep while objective measurement was assessed by polysomnography. 

In one study of 483 participants (193 received 15 or 20 mg of Belsomra and 290 received placebo) a statistically significant difference in time to fall sleep was observed in sleep onset (8 fewer minutes compared to placebo) and stayed asleep longer (17 fewer minutes awake compared to placebo) at the end of 3 months. The superiority of Belsomra compared to placebo was similar in the other studies and with patient reported measurements.

Belsomra has not been compared to other medications used for the treatment of insomnia (e.g., Ambien, Lunesta) therefore it is unknown how Belsomra directly compares to these medications in safety and effectiveness.


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