Drug

Daridorexant

84 flagged reaction(s) · 2,805 total co-reports · max PRR 65.0

Important: Reactions below are the flagged terms from this drug’s FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate disproportionality in spontaneous reporting, not causation. Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.

	Reaction	Co-reports (a)	PRR	ROR	Signal
1	Nightmare	275	65.0	72.6	signal
2	Product Availability Issue	148	54.1	57.4	signal
3	Abnormal Dreams	137	40.3	42.6	signal
4	Brain Fog	44	24.6	25.1	signal
5	Middle Insomnia	55	24.2	24.7	signal
6	Poisoning Deliberate	25	21.9	22.1	signal
7	Initial Insomnia	19	15.2	15.3	signal
8	Poor Quality Sleep	37	14.1	14.3	signal
9	Paralysis	18	10.2	10.3	signal
10	Insomnia	315	9.6	10.8	signal
11	Impaired Driving Ability	13	9.3	9.4	signal
12	Therapeutic Product Effect Incomplete	78	9.0	9.2	signal
13	Sluggishness	11	8.8	8.9	signal
14	Nocturia	13	8.8	8.8	signal
15	Restless Legs Syndrome	19	8.5	8.6	signal
16	Hallucination	76	8.3	8.5	signal
17	Suicidal Ideation	89	7.9	8.2	signal
18	Intentional Overdose	59	7.5	7.7	signal
19	Restlessness	33	7.3	7.4	signal
20	Somnolence	170	6.9	7.3	signal
21	Loss Of Personal Independence In Daily Activities	37	6.3	6.4	signal
22	Joint Dislocation	8	6.2	6.2	signal
23	Therapeutic Product Effect Decreased	33	6.1	6.1	signal
24	Product Prescribing Issue	15	6.0	6.0	signal
25	Hypersomnia	21	6.0	6.0	signal
26	Mania	12	6.0	6.0	signal
27	Night Sweats	23	5.8	5.9	signal
28	Oral Candidiasis	9	5.6	5.7	signal
29	Dysarthria	26	5.6	5.7	signal
30	Inappropriate Schedule Of Product Administration	121	5.6	5.8	signal
31	Disturbance In Attention	37	5.6	5.6	signal
32	Feeling Jittery	13	5.5	5.6	signal
33	Hallucination, Visual	14	5.4	5.5	signal
34	Aphonia	9	5.3	5.3	signal
35	Tardive Dyskinesia	18	5.1	5.2	signal
36	Fibromyalgia	15	5.0	5.1	signal
37	Hand Deformity	8	5.0	5.0	signal
38	Peripheral Coldness	8	4.7	4.7	signal
39	Hepatic Cytolysis	7	4.7	4.7	signal
40	Muscle Twitching	13	4.6	4.6	signal
41	Product Packaging Quantity Issue	6	4.5	4.5	signal
42	Agitation	40	4.4	4.5	signal
43	Bone Loss	8	4.3	4.3	signal
44	Serotonin Syndrome	10	4.3	4.3	signal
45	Feeling Abnormal	122	4.1	4.3	signal
46	Neuroleptic Malignant Syndrome	6	4.1	4.1	signal
47	Coma	24	4.1	4.1	signal
48	Vaginal Discharge	5	4.1	4.1	signal
49	Gastroenteritis Viral	9	4.1	4.1	signal
50	Ear Discomfort	5	4.0	4.0	signal
51	Meningioma	7	3.9	3.9	signal
52	Anger	16	3.8	3.9	signal
53	Sedation	12	3.8	3.8	signal
54	Depressed Mood	24	3.7	3.7	signal
55	Wrong Technique In Product Usage Process	89	3.6	3.7	signal
56	Panic Attack	16	3.6	3.6	signal
57	Suicide Attempt	26	3.5	3.5	signal
58	Coordination Abnormal	6	3.5	3.5	signal
59	Thinking Abnormal	8	3.5	3.5	signal
60	Leukaemia	4	3.5	3.5	signal
61	Product Prescribing Error	10	3.4	3.5	signal
62	Migraine	39	3.3	3.4	signal
63	Hemiparesis	7	3.3	3.4	signal
64	Circulatory Collapse	7	3.3	3.3	signal
65	Illness	41	3.3	3.4	signal
66	Scar	7	3.3	3.3	signal
67	Respiratory Depression	5	3.3	3.3	signal
68	Paranoia	7	3.3	3.3	signal
69	Brain Injury	4	3.2	3.3	signal
70	Hallucination, Auditory	6	3.1	3.1	signal
71	Mood Swings	12	3.1	3.1	signal
72	Psychomotor Hyperactivity	6	2.9	2.9	signal
73	Glossodynia	8	2.9	2.9	signal
74	Myoclonus	4	2.7	2.7	no signal
75	Product Dispensing Error	7	2.6	2.6	signal
76	Irritability	18	2.4	2.4	signal
77	Akathisia	4	2.4	2.4	no signal
78	Eye Pruritus	9	2.2	2.2	signal
79	Bone Density Decreased	8	2.1	2.1	no signal
80	Product Physical Issue	5	2.0	2.0	no signal
81	No Adverse Event	41	1.9	1.9	no signal
82	Product Taste Abnormal	3	1.8	1.8	no signal
83	Abortion Spontaneous	8	1.6	1.6	no signal
84	Completed Suicide	15	1.5	1.5	no signal