• Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
• Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

• Change From Baseline in the Total HAM-A Score After 1 Week [ Time Frame: Baseline and 1 week ] [ Designated as safety issue: No ]
• Change From Baseline in the Total HAM-A Score After 2 Weeks [ Time Frame: Baseline and 2 Weeks ] [ Designated as safety issue: No ]
• Change From Baseline in the Total HAM-A Score After 3 Weeks [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in the Total HAM-A Score After 4 Weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in the Total HAM-A Score After 5 Weeks [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in the Total HAM-A Score After 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in the Total HAM-A Score After 7 Weeks [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in the Total HAM-A Score After 8 Weeks [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period [ Time Frame: Baseline and at endpoint during the 8 week treatment period ] [ Designated as safety issue: No ]
• Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
• Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
• Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
• Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
• Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
• Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period [ Time Frame: at endpoint during the 8 week treatment period ] [ Designated as safety issue: No ]
• Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
• Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
• Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
• Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period [ Time Frame: Baseline and at endpoint during the 8 week treatment period ] [ Designated as safety issue: No ]
• Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
• Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
• Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
• Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
• Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
• Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period [ Time Frame: at endpoint during the 8 week treatment period ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-insomnia Subscore After 1 Week [ Time Frame: Baseline and 1 week ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period [ Time Frame: Baseline and at endpoint during the 8 week treatment period ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week [ Time Frame: Baseline and 1 week ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period [ Time Frame: Baseline and at endpoint during the 8 week treatment period ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-somatic Subscore After 1 Week [ Time Frame: Baseline and 1 week ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-somatic Subscore After 2 Weeks [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-somatic Subscore After 3 Weeks [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-somatic Subscore After 4 Weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-somatic Subscore After 5 Weeks [ Time Frame: Baseline and 5 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-somatic Subscore After 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-somatic Subscore After 7 Weeks [ Time Frame: Baseline and 7 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-somatic Subscore After 8 Weeks [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
• Change From Baseline in HAM-A-somatic Subscore at Endpoint During the 8 Week Treatment Period [ Time Frame: Baseline and at endpoint during the 8 week treatment period ] [ Designated as safety issue: No ]
• Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week [ Time Frame: 1 week ] [ Designated as safety issue: No ]
• Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
• Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
• Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
• Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
• Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
• Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) at Endpoint During the 8 Week Treatment Period [ Time Frame: at endpoint during the 8 week treatment period ] [ Designated as safety issue: No ]

An 8-week, open-label trial in 848 subjects at 212 sites to compare time to response in symptoms of anxiety in subjects treated with Niravam™ and a newly prescribed Selective Serotonin Reuptake Inhibitor (SSRI)or Serotonin and Norepinephrine Reuptake Inhibitor (SNRI) to that in subjects treated with a newly prescribed SSRI/SNRI alone. Subjects must be at least 18 years of age and positive for Generalized Anxiety Disorder (GAD)or Panic Disorder. Subjects will be randomized to receive concomitant Niravam™ and an SSRI/SNRI or an SSRI/SNRI alone during the study. Most symptom evaluations will be done using an automated phone interview system. There are 4 clinic visits.

• Generalized Anxiety Disorder
• Panic Disorder

• Drug: Niravam
• Drug: SSRI/SNRI

• Experimental: Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
• Experimental: Panic Disorder: Newly prescribed SSRI or SNRI alone
• Experimental: Generalized Anxiety Disorder: Niravam plus a newly prescribed SSRI or SNRI
• Experimental: Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone

Inclusion Criteria:

• Must be at least 18 years of age.
• Diagnosed by the Investigator with primary Generalized Anxiety Disorder (GAD) and/or primary Panic Disorder with or without agoraphobia, either primary episode or recurrence, and is positive for GAD or Panic Disorder by the MHS (Mental Health Screener)).
• Receiving a new prescription for all SSRI or SNRI as indicated for GAD or Panic Disorder with or without agoraphobia. Definition of a new prescription in case of a recurrence in symptoms is no prescription or refill of prescription of SSRI or SNRI for the past 6 months.
• Subject is informed and given ample time and opportunity to think about his/her participation and has given his/her written informed consent.

Exclusion Criteria:

• Presence of medical condition or presence of schizophrenia, bipolar disorder, alcohol abuse/dependence or any other primary major psychiatric disorder that, in the opinion of the Investigator, would jeopardize the subject or compromise the subject's ability to participate in the trial.
• Is a current suicide risk in the opinion of the Investigator.
• Has initiated cognitive therapy within two months of Study Day 1.
• Does not speak English or does not hear well enough to be able to perform the Hamilton Anxiety (HAM-A) Rating Scale and Mental Health Screener (MHS) by Interactive Voice Response System (IVRS).
• Has taken a benzodiazepine within the past 30 days.
• History of hypersensitivity or allergic response to any of the components of SSRIs, SNRIs, benzodiazepines, or related drugs.
• If a female of child-bearing potential, is pregnant, nursing, or not using appropriate birth control methods.
• Presence of contraindications to the SSRI or SNRI to be prescribed per the specific package insert.
• Presence of acute narrow angle glaucoma or taking ketoconazole or itraconazole,which are contraindications to Niravam per the package insert.
• History of phenylketonuria (PKU).
• Participation in a previous clinical trial within 30 days prior to Study Day 1.