Belsomra

Treats insomnia characterized. NDA 204569, held by Merck Sharp Dohme. Suvorexant.

As of Nov 13, 2026, NDA 204569 (Belsomra), held by Merck Sharp Dohme, was first approved by FDA on Aug 13, 2014, with 9 approved supplements and 1 published complete response letter.

First approved: Aug 13, 2014
Review: Standard
Supplements approved: 9
Complete response letters: 1

What It's For

From the FDA-approved label (Indications and Usage)

BELSOMRA (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. BELSOMRA is an orexin receptor antagonist indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Jan 29, 2020	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 13, 2014	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Label Letter

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
Jun 28, 2013	Suvorexant (MK-4305)Effectiveness, Safety, Labeling	Approved

Products

4 strengths and forms

Product	Active ingredient	Marketing
Belsomra5MG · tablet;oral	Suvorexant	RxReference drug
Belsomra10MG · tablet;oral	Suvorexant	RxReference drug
Belsomra15MG · tablet;oral	Suvorexant	RxReference drug
Belsomra20MG · tablet;oral	Suvorexant	RxReference drug

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 10, 2025	Supplement 10Labeling · Standard review	Approved	Letter Label Medication Guide
Mar 25, 2021	Supplement 8Labeling · Standard review	Approved	Letter Label
Mar 18, 2020	Supplement 7Labeling · Standard review	Approved	Label Letter
Jan 29, 2020	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 12, 2018	Supplement 5Labeling · Standard review	Approved	Letter Label
May 27, 2016	Supplement 4Labeling · Standard review	Approved	Letter
May 3, 2016	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 30, 2015	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 7, 2014	Supplement 1Labeling · Standard review	Approved	Letter Label
Aug 13, 2014	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 204569
Drugs@FDA: Overview at FDA
Company: Merck Sharp & Dohme

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters