Hospice Medication Alert: New Drug for Insomnia – Belsomra (Suvorexant)

 In Medication Alerts

alert2Belsomra (Suvorexant), which was given FDA approval in August, 2014, became available early this year. Belsomra works as an orexin receptor antagonist. Orexins are chemicals that are involved in regulating the sleep-wake cycle and play a role in keeping people awake. It is the first drug approved with this mechanism of action.

Belsomra is a schedule IV controlled substance, which is the same category as temazepam (Restoril) and zolpidem (Ambien), due to its potential for abuse and dependence. It is available as 5, 10, 15, and 20 mg tablets, and should be taken no more than once per night, within 30 minutes of going to bed. It is recommended that the lowest effective dose be used and the total dose should not exceed 20mg once daily. A Medication Guide addressing safety issues should be handed out with all Belsomra prescriptions.

In clinical trials, patients taking Belsomra fell asleep faster and spent less time awake during the night. However, these studies compared Belsomra to placebo instead of other drugs approved to treat insomnia. Therefore, it is unknown if Belsomra is superior to other hypnotics in terms of effectiveness and safety. The side effects are similar to other sleep medications: somnolence, headache, abnormal dreams, next-day drowsiness, sleep-driving and other complex behaviors while not fully awake. The FDA initially rejected high doses of Belsomra- 30mg and 40mg because they posed a dangerous risk of next-day drowsiness. The clinical trials showed that people who took a 15 mg or 20 mg dose of Belsomra every night for 3 months fell asleep just 6 minutes faster on average than those who got a placebo pill and slept only 16 minutes longer compared to the placebo group. The recommended starting dose of 10 mg was only studied in 62 people for 1 month and it is unclear whether it improves sleep. The 5 mg dose was not studied at all, so its effect is unknown.

Other than a new mechanism of action, Belsomra does not provide any additional benefits in the hospice setting. With a similar efficacy and safety profile, the use of Belsomra is very limited due to its high cost and the availability of other hypnotics.

Cost comparison of Belsomra to other hypnotic alternatives (15-day supply):

  • Belsomra 10mg QHS — AWP $158
  • Zolpidem (Ambien) 10mg QHS — AWP $70
  • Temazepam 15mg QHS — AWP $11
  • Trazodone 100mg QHS — AWP $11

References:

  1. Belsomra® [package insert]. Whitehouse State, NJ: Merck & Co., Inc; 2014.
  2. Citrome L. Suvorexant for insomnia: a systematic review of the efficacy and safety profile for this newly approved hypnotic. Int J Clin Pract.
    2014 Dec;68(12):1429-41.

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