Drug Safety Information for BELSOMRA (Suvorexant)

Safety-related Labeling Changes for BELSOMRA (SUVOREXANT) Rx Drug: FDA Link

Adverse Drug Reactions for BELSOMRA* (Suvorexant)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with BELSOMRA
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Drug ineffective	367
2	Nightmare	104
3	Abnormal dreams	93
4	Somnolence	77
5	Headache	67
6	Feeling abnormal	59
7	Insomnia	56
8	Hallucination	35
9	Nausea	32
10	Poor quality sleep	28
11	Dizziness	26
12	Wrong technique in drug usage process	25
13	Palpitations	24
14	Middle insomnia	23
15	Anxiety	22
16	Fatigue	19
17	Sleep paralysis	18
18	Agitation	16
19	Adverse event	14
20	Tremor	14

* This side effect also appears in "Top 10 Side Effects of BELSOMRA " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking BELSOMRA
(associated with FDA Medwatch/FAERS Reports)

	Reason	# of FDA Reports
1	Insomnia	1455
2	Sleep disorder	42
3	Sleep disorder therapy	14
4	Circadian rhythm sleep disorder	7
5	Poor quality sleep	6
6	Middle insomnia	6
7	Depression	2
8	Suicide attempt	2
9	Product used for unknown indication	1

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for BELSOMRA

Total Reports Filed with FDA: 1828

Number of FDA Adverse Event Reports by Patient Age for BELSOMRA

Total Reports Filed with FDA: 1828*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Suvorexant (Belsomra)

Charts are based on 1828 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.